SPECIAL FEATURE - Injection Devices: From Pens & Autoinjectors to Pills, Sprays & Capsules, Injections Become More Efficient

The pharma community has made incredible advancements in developing injectable devices that are less painful, ensure precise drug delivery, reduce injection frequency, and integrate with digital health technologies – all of which are important for patients treating chronic diseases. As the comfort level for patients to self-administer medication rises, so too does the global injection drug delivery market. Estimated to be valued at $757.06 billion this year, the market is projected to reach 1,630.73 billion by 2033, according to Nova One Advisor.

While most of the innovation witnessed is in patient-centric devices like autoinjectors and pen devices, there are exciting alternatives hitting the market. For example, the Food and Drug Administration just approved ARS Pharmaceuticals’ neffy epinephrine nasal spray for severe allergic reactions. This makes it the first non-needle epinephrine treatment available in the United States for adults and older kids with food, sting or drug allergies. In a statement, ARS Pharma’s president and CEO said: “This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies. The sprayer is a treatment alternative that avoids the need to inject epinephrine with a needle.”

Avoiding needles is the reason why oral drug delivery remains the most widely used route of delivery. Companies like Rani Therapeutics recognize this and de­veloped what it believes is disruptive tech­nology for the oral delivery of biologics: the RaniPill Platform. The RaniPill Capsule is a robotic pill that moves fully intact through the stomach and reaches the in­testine to deliver drug via transenteric in­jection. In February, Rani announced positive topline results from its Phase 1 clinical study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43. In the study, RT-111 was well-toler­ated and delivered ustekinumab with high bioavailability.

“We are highly encouraged by the positive results from our Phase 1 study for RT-111 – our third successfully completed Phase 1 trial using RaniPill technology,” said Talat Imran, Chief Executive Officer of Rani in a press release. “To our knowl­edge, RT-111 is the first ever oral mono­clonal antibody to achieve high bioavailability in humans. These data pro­vide clinical validation of our ability to suc­cessfully transform an injectable large molecule into an oral pill. Specifically for this program, we believe RT-111 has the potential to offer a highly differentiated dosing regimen for patients with psoriasis compared to both injectable biologics and oral small molecules and peptides.”

Researchers have developed an in­jectable capsule, known as L-SOMA engi­neered with an advanced driving and delivery mechanism. This system facilitates the encapsulation of both small-molecule drugs and large-molecule drugs, such as monoclonal antibodies, while doubling the drug loading capacity. L-SOMA can achieve a peak plasma concentration akin to subcutaneous injection standards within a 30-minute post-administration, and can reach bioavailability of 80% within a few hours. Alex Abramson, Assistant Professor at Georgia Institute of Technology, explains that to deliver the drug, the L-SOMA uses a staged and sequence controlled multi-spring actuation system that injects a hy­podermic needle beneath the gastric mucosa and thereupon delivers 80μL of liquid drug formulation into the submu­cosal space. The L-SOMA’s actuation mechanism is located on the shell of the device, eliminating the need for gastric fluid to enter the pill and be in contact with the loaded drug before injection. A dissolv­ing pellet, accessed through a hole on the top of the pill, holds an injection molded needle hub in place using a latching mechanism. Over time, this pellet dis­solves. Once actuated, the L-SOMA first in­serts a needle into the tissue to a defined distance using an excess of force. Then it uses a second spring to push down on a plunger that drives the liquid drug formu­lation through the needle and into the gas­tric submucosa. Two membranes seal off the dose storage area and prevent leakage as the plunger pushes the liquid through a side hole in the needle and out via the needle’s tip. By decoupling the needle in­sertion from the liquid injection, the device achieves delivery of its entire dose deep within the tissue instead of releasing the dose as the needle moves through the tis­sue. He says this staged injection system prevents any of the dose from expelling into the gastric fluid where it could be de­graded.

This exclusive Drug Development & Delivery annual report highlights other in­novative and promising injection technolo­gies that are ever more user friendly, versatile, precise, and life- saving.

ApiJect: Prefilled Autoinjector Overcomes Prohibitive Pricing

Autoinjectors and other take-home in­jection delivery devices are removing bar­riers for patient access to the medicine they need. ApiJect’s mission is to make in­jectable medicines and vaccines safe and accessible to everyone. The company helps pharmaceutical companies design rapidly scalable, affordable, easy to use, and sustainable drug delivery systems.

The ApiJect platform, for example, creates prefilled injection devices by bring­ing together Blow-Fill-Seal (BFS) advanced aseptic drug packaging with attachable drug delivery components. This allows the ApiJect platform to create safe, affordable, and easy-to-use prefilled drug delivery sys­tems.

Joseph Wojcik, MBA, PMP, Senior Di­rector, Pharmaceutical Sciences, ApiJect, explains that in high-income countries, autoinjectors are popular because of their convenience and their price point is not prohibitive when compared to visiting a hospital or clinic. However, in a low- or middle-income country, the autoinjector is likely more expensive than the clinic visit (and certainly more expensive than at-home use of a vial and syringe).

“Its high price point significantly de­creases its demand, which in-turn reduces access for those who can afford it,” he says. “The ApiJect platform can transform this situation by providing the safety and ease-of-use of a prefilled format at a price point that more people can afford across the globe – helping to increase access to more injectables using market forces.”

ApiJect is currently working with a client to solve a problem related to use and access of their injectable drug product in low- and middle-income countries. By leveraging the ApiJect technology platform and ApiJect’s Global Health, Device Design, and Product Development teams, ApiJect has collaborated with this client to develop a solution that meets the specific device delivery needs of their drug product and addresses “Last Mile” issues that limit access to critical medicines, says Mr. Wojcik.

Artcraft Health: No-Fail Autoinjector Training

Known for their ease of use, autoin­jectors are quickly becoming the most popular type of self-injection device be­cause they are pre-dosed and straightfor­ward for patients to learn, which reduces the risk of user error.

Artcraft Health is a full-service health education agency that partners with pharma, biotech healthcare service, and medical device companies. Artcraft has long served the injectables market with demonstration device training, particularly with autoinjectors, for which there is an ongoing need to ensure successful patient onboarding.

“The most critical part of autoinjector use is patient training,” says Marty Mason, Senior Director of Demonstration and Training Devices at Artcraft Health. “An au­toinjector is only as good as the training that accompanies it,” he says.

To meet the biggest unmet need of the autoinjector market, Artcraft has recently developed the first autoinjector training device that delivers no-fail training, even if the device itself fails. Artcraft’s demoX™ training device – the industry’s first electronic autoinjector training device – delivers no-fail training by using pre-pro­grammed movements to replicate the functions of a commercial autoinjector with zero-motion variability, he explains.

If demoX starts to fail due to loss of power, a battery indicator light prompts the clinician to give the device a 5-minute recharge to restore its no-fail perform­ance, so clinicians never experience a training failure – even if the device itself fails.

According to Mr. Mason, “demoX was created to solve the problem of autoinjec­tor training devices that don’t last as long as projected and exhibit problematic vari­ations in key functions such as plunger drop and in the sound of the audio click. As a fully rechargeable electromechanical device, demoX avoids the rapid wear and tear that befall traditional devices and eliminates the motion and timing variabil­ity that has become a sore point for the in­dustry. In fact, demoX is engineered to last five times longer than previous genera­tions of training devices.” As an added benefit for clients, the demoX device has an internal counter that tells sales reps how many times the HCP has used the de­vice.

In addition to the launch of demoX, Artcraft Health has deep portfolio experi­ence in connected and wearable devices, having created electromechanical training devices for several injection systems. The accuDemo technology, launched last year, is a training platform that eliminates 100% of user errors in every onboarding session, says Mr. Mason.

BD: Range of Devices Deliver Complex Biologics

A broad portfolio of drug delivery sys­tems designed for high-volume and com­plex biologics is available from BD and are designed to be intuitive, reliable and enhance the overall patient experience. The BD Effivax™ Glass Prefillable Syringe, BD Libertas™ Wearable Injector, and the BD Neopak™ XtraFlow™ Glass Prefillable Syringe are at the forefront of addressing challenges in subcutaneous drug delivery. The BD Effivax Glass Prefillable Syringe, for example, is designed for reliability and efficiency, particularly in high-volume vac­cine production, addressing the need for scalable solutions in pandemic prepared­ness. The BD Neopak XtraFlow Glass Pre­fillable Syringe is designed to enhance patient comfort with reduced injection force. Coupling the BD Neopak XtraFlow Glass Prefillable Syringe and the BD SCF™ PremiumCoat® Plunger Stopper, BD can provide pharmaceutical companies with a system that is compatible with a range of biologics.

“These devices collectively address key challenges in the sector, including patient  experience, device usability, and the scalability of drug delivery solutions,” says Beth DiLauri, Director, Portfolio Marketing BD – Medical Pharmaceutical Systems.

The BD Neopak XtraFlow Glass Pre­fillable Syringe system was developed in response to pharmaceutical partners’ needs for a device that could deliver highly viscous biologics without compromising patient comfort, explains Ms. DiLauri. The BD Neopak XtraFlow Glass Prefillable Sy­ringe reduces the injection force required to deliver higher viscosity biologics, mak­ing it easier for patients to self-administer their medication. “This innovation not only addressed the specific challenge faced by our partner, but also can enhance the overall patient experience by minimizing discomfort during injection,” she says. “Furthermore, BD’s ability to scale up pro­duction and maintain high-quality stan­dards ensured that the product meets the rigorous demands of both the pharmaceu­tical partner and regulatory bodies.”

BD also recognizes the increasing im­portance of connectivity and wearable de­vices in enhancing patient care. The BD Libertas™ Wearable Injector is a ready-to-use drug delivery system that supports the shift towards self-administration by en­abling the subcutaneous delivery of large volumes of medication, which is crucial for biologics.

BD also acquired Edwards Life­sciences’ Critical Care to expand its smart connected care solutions. “This acquisi­tion, along with the development of AI-dri­ven clinical decision tools, positions BD as a leader in the integration of connectivity with drug delivery,” Ms. DiLauri says. “We are committed to advancing our portfolio to include more wearable and connected devices that provide real-time data and improve patient outcomes.”

Although specific product details can­not be disclosed now, BD is focused on de­veloping future-ready solutions that integrate connectivity to support patients and healthcare providers in making in­formed decisions based on real-time data.

Credence MedSystems, Inc.: A Platform of Solutions Addressing Emerging Challenges

Ongoing trends in the pharmaceuti­cal industry are creating significant chal­lenges to the safe and effective delivery of injectable medications. And, there are sev­eral challenges that need to be solved by innovative drug delivery systems, says John Merhige, Chief Commercial Officer, Credence MedSystems, Inc.

For example, more difficult-to-admin­ister formulations need to be delivered by more naïve users in less formal settings. In obesity and diabetes therapies, pipeline programs will require self-administration of formulations that require separation of constituents during storage due to stability or coformulation challenges. Dose vol­umes are getting both smaller (in applica­tions such as ophthalmology and medical aesthetics) and larger (in biologics for chronic disease) while greater dose accuracy is needed due to safety issues. Users prefer a preattached needle to re­duce the number of administration steps and facilitate administration, but formula­tions and suspensions with high concen­tration and viscosity are leading to injection failures stemming from needle clogging. And the general pressures on cost containment persist while enhanced sustainability continues to emerge as an industry imperative.

“Credence’s philosophy of Innovation Without Change has resulted in a product portfolio that provides solutions to these challenges while reducing the risk and burden of implementation,” he says. “Cre­dence achieves this by utilizing industry-standard primary package components and increasing efficiency of existing man­ufacturing processes.”

For example, the Credence Compan­ion® provides integrated passive needle safety, numerous user cues to ensure safe  administration, and a reduced environ­mental footprint to promote adherence while supporting pharma’s sustainability goals and eliminating steps in the manu­facturing process. The Companion plat­form offers flexibility, enabling larger barrels to be employed as needed.

Additionally, the Credence Dual Chamber platform enables at-home ad­ministration of complex drug products that require separation of constituents during storage due to stability or co-formulation challenges. The Dual Chamber platform utilizes industry-standard prefilled syringes either with a pre-attached retracting nee­dle or with a luer lock front end, offering flexibility to customize for different dose volumes, administration routes, and user requirements. “Whether point-of-care re­constitution or sequential injection of two liquids is required, the usability resembles that of a single-chamber PFS,” says Mr. Merhige. “This has the potential to change the paradigm for these challenging formu­lations, allowing pharma manufacturers to reduce development expense and shorten time to market while presenting these medicines in formats that enable success­ful administration.”

Companion and Dual Chamber are flexible enough to administer injectables as stand-alone systems or with an autoin­jector. Credence is, therefore, collaborat­ing with industry leaders on autoinjector offerings that can leverage the inherent benefits of both devices. The disposable single-use autoinjector is more common in the industry today. In this format, Com­panion’s end-of-dose cues and integrated needle retraction simplify the autoinjector by removing functionality requirements it had previously needed to address. Beyond that, Companion helps to enable further adoption of a reusable autoinjector. After use, Companion protects the needle in the plunger rod, allowing for safe and easy re­moval by the user. And because Compan­ion’s integrated safety eliminates the traditional add-on wrap around device, the disposed portion represents minimal plastic in a small footprint, thereby accen­tuating the sustainability impact of the reusable autoinjector offering. “In this way, Companion with a reusable autoinjector creates the greatest sustainability value for the industry,” says Mr. Merhige.

Crossject: Differentiating in Speed & Indications

When it comes to autoinjectors, pa­tients prioritize devices that are easy to use, convenient to store, effective and safe in treatment, and affordable. The ongoing advancements in autoinjector technology offer significant benefits to various stake­holders by reducing the need for burden­some and expensive clinic and hospital visits. Consequently, the demand and ac­ceptance of innovative autoinjectors are steadily increasing among patients, care­givers, advocacy groups, physicians, and cost-conscious insurance providers. Fur­thermore autoinjectors have a lower pa­tient-to-patient and intra-patient dosing variability compared to oral or nasal routes of administration, thus ensuring the dose is accurately received, says Patrick Alexandre, Founder and CEO of Crossject.

Crossject’s ZENEO® is a needle-free autoinjector platform designed to deliver a variety of drugs via intramuscular or subcutaneous injection. Its patient-friendly, compact design and simple administration make it especially well-suited for pre-hos­pital treatments and emergency situations. “The needle-free technology not only en­hances patient experience, it also offers the potential to improve compliance and adherence, making it an attractive option for patients valuing ease of use and mini­mal discomfort,” he says.

One the differentiating benefits of the ZENEO autoinjector is the speed of injec­tion – it delivers the medication in less than 0.1 seconds. The rapid delivery effectively minimizes the risk of administration errors or needle lacerations, says Mr. Alexandre.

“Moreover, the high velocity of drug delivery utilizing ZENEO has shown prom­ising drug delivery results, as highlighted in our latest clinical trial,” he says. “The  study demonstrated that ZENEO achieves higher mean drug concentrations within the first 10 minutes as well as a quicker in­jection process, leading to a potential faster onset of action for the injected drug. This rapid response is crucial for condi­tions like seizures where it can prevent prolonged episodes and associated neu­rological complications.”

ZENEO also has the potential to ele­vate the standard of care for a wide range of health conditions that require immedi­ate, emergency treatment. The company’s current focus is to provide patient-centric rescue solutions that are safe, reliable, and effective, with rapid drug delivery that can be easily administered when time is of the essence, such as the epilepsy market. Crossject is moving toward submitting a New Drug Application to the FDA in 2025 for Zepizure®. Additionally, Crossject is ad­vancing two additional programs, ZENEO Hydrocortisone and ZENEO Adrenaline, with plans for market authorization filings soon after the Zepizure NDA submission.

ZENEO also holds promise for chronic conditions, says Mr. Alexandre. “Clinically, ZENEO has proven its capabil­ity to deliver both small and large mole­cules, regardless of viscosity, with the same precision and speed as our emergency drug applications. The ability to inject drugs easily and rapidly, without a needle and even through clothing, positions ZENEO as a differentiating factor in vari­ous therapeutic areas, including oncology, dermatology, obesity, cardiology, and res­piratory care.”

Duoject Medical Systems: Making Complex Lyo Therapies Accessible & Manageable

One of the main factors driving the injectable delivery sector is the develop­ment of biologics, including vaccines, an­tibody-drug conjugates, and monoclonal antibodies, which often cannot be deliv­ered orally due to the complexity of their molecules and precise administration method requirements. Injectable therapies often provide rapid onset of action and improved bioavailability when compared to oral medications.

Duoject develops novel medical de­vices that enhance the safety, convenience, and compliance of injectable therapies, with a focus on patient-centric care. Its technologies aim to help reduce dosing er­rors and improve the patient experience by emphasizing ease of use and minimizing discomfort associated with injections, al­lowing patients to manage their conditions at home and reduce the need for frequent hospital visits.

Duoject’s Raven is a new preassem­bled all-in-one reconstitution and injection device designed for seamless home care use. This device integrates both a diluent cartridge and lyo drug vial into a single, compact unit, enabling the reconstitution of the medication with a few simple steps prior to self-administration using a stan­dard pen needle for convenience. Raven is a single-use, sterile device, eliminating the need to manually handle multiple components, simplifying the preparation process and reducing the risk of contami­nation and dosing errors, explains Daniel MacDonald, Director of Drug Delivery Sys­tems, Duoject Medical Systems.

“This new design addresses a significant challenge in the pharmaceutical in­dustry: ensuring accurate and safe admin­istration of reconstituted drugs in a home care setting,” he says. “Traditional meth­ods of drug reconstitution and injection often require multiple steps and a high level of precision, which can be daunting for patients, especially those with limited medical training. By simplifying the recon­stitution and injection process into a single, user-friendly device, Duoject’s Raven en­hances patient adherence to treatment regimens, leading to better health out­comes.”

Moreover, the device’s safety features, such as hidden transfer needle, locking mechanism to prevent reuse, and consis­tent dosing improve the overall safety pro­file of injectable medications, addressing concerns of contamination and dosing in­accuracies, says Mr. MacDonald. “This in­novation represents a significant step forward in making complex lyophilized in­jectable therapies more accessible and manageable for patients worldwide.”

Enable: Hands-Free, Wearable Administration Delivers Up to 25mL

Biologics continue to dominate pipelines and portfolios. In fact, more than 45% of global biologics doses are greater than 5mL. These products are viscous, concentrated, and are increasingly re­quired to be high-volume to be efficacious. Large volumes of medication often require administration either intravenously or sub­cutaneously using a syringe and needle, or via a syringe pump – delivery methods that can involve lengthy clinic visits, large needles, and often painful procedures. This is where Enable sees a clear need for innovation.

“The main obstacle with autoinjectors is they often don’t have the capacity to support large volumes of medication,” says Matt Huddleston, Chief Commercial Officer, Enable. “This is why we believe en­Fuse offers such a unique and incredible opportunity. enFuse features the first-ever hands-free, wearable technology designed to deliver large volumes of therapeutics subcutaneously (up to 25mL with a single enFuse, or up to 100mL with multiple en­Fuses worn simultaneously), in which pa­tients receive their needed treatment through a simple injection under the skin, instead of intravenously.”

Purposely designed to be completely mechanical, enFuse doesn’t require wiring or tubing, therefore allowing hands-free administration that enables patients to move freely and perform light to moderate activities while medication is being admin­istered. After adhering to skin with adhe­sive, a thin, hidden needle comfortably and silently delivers medication into the skin. An indicator shows when the medica­tion has been fully delivered and the nee­dle automatically retracts.

With a design that allows compatibil­ity with small molecule and biologic drug formulations across a range of viscosities and volumes, enFuse is applicable across various therapeutic areas and offers phar­maceutical partners a unique opportunity to differentiate their drug development programs and medication offerings. Pharma companies also have greater flex­ibility for streamlining formulation changes from intravenous to subcutaneous with en­Fuse technology flexibility, potentially in­creasing time to market, he says.

In October 2023, the FDA approved the first enFuse combination product – the EMPAVELI Injector – marketed by Apellis, to enhance self-administration of EM­PAVELI for adults with paroxysmal noctur­nal hemoglobinuria (PNH). As a result, the EMPAVELI Injector has elevated the stan­dard of care in PNH and the treatment ex­perience for patients living with this chronic condition, says Mr. Huddleston. Most re­cently, Enable announced a partnership with Serina Therapeutics to develop and commercialize SER-252, an investigational apomorphine therapy, in combination with enFuse for a potential best-in-class treat­ment of Parkinson’s disease.

He explains that unlike other apomor­phine treatments that require daily, time-consuming infusions via an electronic pump – leading to patient and physician burden and potential significant skin reac­tions – enFuse allows patients to self-ad­minister SER-252 with a quick, simple injection under the skin, all from the com­fort of their home.

In addition to Apellis and Serina, En­able has entered into multiple shared-value partnerships with other leading drug developers, including CSL Behring, Roche, Sanofi, UCB, and Viridian.

Flex: Smart Syringe Design Platform Accelerates Time to Market

Exceptional user-centered design and human machine interface are the founda­tion of rapid adoption of autoinjectors by leveraging natural behaviors to make complex devices seem effortless. Innova­tions driven by technology advancements in connected devices – such as artificial in­telligence for decision support – enhance safety and accuracy through real-time monitoring and predictive analytics, and can further fuel customer confidence and increase adoption.

Last year, Flex introduced a reference design platform for developing prefilled syringes (PFS). “The smart syringe refer­ence design platform is part of our goal to enable pharma companies to offer the most advanced drug delivery solutions for patient care,” explains Jennifer Samproni, Chief Technology Officer, Health Solutions, Flex. “It provides advanced technology housed in a common syringe form factor for ease of use and improved dose accu­racy, and its sensors for connectivity allow data collection and post-use analysis as well as the ability to monitor patients re­motely.”

These new features were designed to fit into small, volume-fill syringes, such as a 1mL PFS. Because the syringe’s piston incorporates digital features and transfers data through Bluetooth low energy (BLE), the drug can be administered and easily monitored without compromising patient privacy and cybersecurity, she says. The smart syringe accurately senses the deliv­ered dose and transmits the injection log together with a timestamp to a clinical study portal. This allows effective injection tracking, while enabling post-use data analysis to enhance the efficacy of clinical trials.

“We also designed the smart syringe with sustainability in mind by using eco-sustainable resin material to lower the product’s carbon footprint and by ensur­ing the syringe is easily disassembled at the product’s end-of-life to enable circular economy processes,” says Ms. Samproni. Cybersecurity concerns have been ad­dressed with the industry-standard AES128-EAX scheme, which provides en­cryption to protect transmitted dose data, as well as syringe-to-cloud secure authen­tication.

Flex’s smart autoinjector reference platform was designed to enable pharma­ceutical companies to accelerate time to market, reduce costs, and boost reliability while ensuring patient compliance and minimizing environmental footprint. The platform was recently used in a product optimization assessment carried out by a leading pharma company. The study helped highlight the varied experiences that patients have with different injection devices and demonstrated the value that reusable autoinjectors with connected fea­tures deliver to patients.

The research involved a focus group of patients from Europe and the US, most of whom had no prior experience using connected devices; they were simply shown key features of Flex’s reference de­sign platform and provided feedback. “The results helped our pharma customer address new device development based on real patient needs, preferences, and concerns,” she says. “Involving a prototype like the smart autoinjector helped them mitigate the risks of designing and testing something from scratch.”

Kahle Automation: Assembling Device Components Without Risking Damage

A rapidly expanding market today is a class of Type 2 diabetes drugs that not only improves blood sugar control, but may also lead to weight loss. These glucagon-like peptide 1 (GLP-1) agonists are most commonly administered via in­jection given daily or weekly. Autoinjectors and pen injectors play a key role in allow­ing the patient to perform this as a self-in­jection at home. Not surprisingly, drug/device manufacturers are desper­ately trying to increase their production ca­pacity to capitalize on this market growth, says John Wuschner, President, Kahle Au­tomation. Some aspects of this expansion are straightforward (make more drug) by processing or storing more, but on the de­vice/packaging side, assembling dozens of precision components using higher out­put systems requires crossing boundaries that have been avoided in the past based on perceived risk and/or capital con­straints.

“Market growth is addressing the capital constraint issue, but these devices utilize components with unique features re­quiring complex assembly and feeding systems, and getting these designs from current to higher volume production rates to meet the surge in demand requires an automation partner who not only under­stands how to get thousands of compo­nents per minute to the assembly machine, but also in a controlled manner without functional or cosmetic damage,” he says.

Feeding of components without caus­ing damage is critical when one considers that an autoinjector or pen injector could have 10 or more different components needing to arrive at the machine at rates exceeding 400 per minute. Mr. Wuschner says: “There are control features on every component that can affect dosage, func­tionality or even safety, and proper han­dling must be ensured to guarantee that these features are preserved. The feeding system designer needs to take each com­ponent’s purpose into consideration dur­ing the development stage and work in partnership with the device manufacturer to arrive at a low-risk solution that meets the production requirements. Sometimes this means that slowing the feedrate itself while multiplying the tooling will allow for this needed control.”

This is also true of the assembly processes. In order to guarantee high yields at higher outputs, faster is not al­ways better. Running a slower speed scal­able through multiplying the tooling allows for a more efficient and controlled assem­bly process. It also allows more time for processes (e.g., welding, sealing, thread­ing) instead of working on the edge of the process, he says. This improves consis­tency and mitigates the risks of assembly because there is a bigger window of oper­ating parameters available.

“By so doing, not only is the probabil­ity of rejects reduced, but also the key per­formance indicators of the product can be managed to generate results that perform equivalently lot to lot, and inspections can be more robust in a stable environment.” A side benefit to this theory of operation is that the equipment is operating at a more controlled rate with lower vibration and wear and generating higher productivity (reduced downtime and maintenance costs).

Lifecore Biomedical: Data-Driven Decisions for Injection Delivery Options

Compared to vials and syringes, get­ting an autoinjector to market may take more time, money, and resources, which could potentially delay the commercializa­tion of an important product. Some com­panies may choose this route, while others may decide to commercialize in a vial and then do work to bring an autoinjector to market post-commercialization. Finding a CDMO that can support scale-up and support flexible container configurations in either situation is valuable.

To mitigate challenges during combi­nation product design verification process and to help de-risk future activities, it is im­portant to make data-driven decisions, says Julie D’Ascenzo, New Business Development Director at Lifecore Biomedical. “This can be done by performing feasibility or characterization studies that allow you to evaluate the component and system-level performance,” she says. “By perform­ing early-stage feasibility work, you will gain confidence that you have selected the appropriate primary packaging or device for your molecule.”

Of what should early-stage feasibility work consist? First, it is important to con­duct a study that spans its shelf life so you understand what can happen 2-3 years down the road. Performing testing at T0 and accelerated aging will give you a full picture of what your product looks like over its shelf life in a shorter period. Sec­ond, it is important to understand some of the challenges that can occur between your drug and container, in this instance a PFS. Areas of concern may be dewetting, particulate formation, and mechanical performance alteration. To ensure that there is no alteration of the mechanical performance of your device over its shelf life, performing breakloose glide force and injection time testing in combination with a lubrication layer analysis at T0 and accelerated aging are studies that allow you to make data-driven device selection decisions.

Another aspect to consider is if you are transitioning from a prefilled syringe (PFS) to an autoinjector. Proactively obtain­ing dimensional data of a PFS and sharing it with your autoinjector manufacturer up front can help decrease overall timelines, says Ms. D’Ascenzo. “While drawings from PFS manufacturers are useful, being able to go one step further to understand all the potential sources of dimensional variability in the system that make up your autoinjec­tor gives insight into what dimensions are critical to device functionality,” she says. “Performing a dimensional evaluation will give you more detailed information and allow you to understand from where po­tential variation is coming. By conducting this work, you are understanding your full system earlier on and better positioning your team for success.”

Nemera: Pen Injectors Facilitate Multi-Dose, High-Volume Dosing

Autoinjectors are quickly becoming the most popular type of self-injection de­vice primarily because they are very intu­itive and simple to use. Their design is user-friendly, often requiring just a single press of a button to administer the med­ication, which minimizes the risk of user error and ensures accurate dosing. How­ever, it is important to note that autoinjec­tors are typically not designed for multiple uses, which raises concerns about sustain­ability, says Cécile Gross, Global Category Manager, Parenteral, Nemera. Despite this, their user-friendly utilization continues to drive their popularity in the market. Ne­mera’s PenDURA and PenVARIO platforms facilitate multi-dose pen injector ranges.

“Our pen injector range, including PenDURA and PenVARIO, addresses the challenge of diabetes by offering practical benefits and sustainable options for pa­tients with chronic diseases,” she says. “Multiple-use capability is practical for pa­tients who need to inject themselves sev­eral times a day. Making treatment easier to take and reducing waste compared with single-use devices provides a cost-effective long-term solution.”

Nemera recently collaborated with a generic drug manufacturer to address the “diabesity” market with a sustainable and economical solution. “They needed a cost-effective option for the Rest of the World (ROW) markets and our custom PenDURA AD was the answer,” says Ms. Gross. “De­signed for GLP-1 injections, it is reusable, which offers a very low cost per injection and maintains sustainability. Working to­gether, we have succeeded in providing a solution to our customers’ needs.”

Nemera is also addressing the chal­lenges of biologics, self-administration, and sustainability in a single device with its Symbioze™ reusable on-body injector. Sumbioze is designed for continuous med­ication delivery, enhancing patient comfort and compliance for those managing chronic conditions.

The Symbioze drug delivery system is a connected and reusable on-body injec­tor suitable for large-volume injections. With embedded Bluetooth connectivity, a recognition system between the reusable and the disposable part, and a dedicated patient application, Symbioze allows pa­tients to monitor their treatment progress in real-time, receive reminders for upcom­ing doses, and track injection history – all from a smartphone or tablet.

“Connectivity and wearable devices are transforming the way patients manage their health, and we are working on this path of innovation,” she says. “By combin­ing advanced wearable technology with connectivity applications, we are enhanc­ing patient engagement, improving treat­ment adherence, and leading to better patient health outcomes.”

Nemera is currently pursuing new markets focusing on high-dose and high-volume medications. Symbioze and Safe’n’Sound® facilitate the administration of high-dose biologics to make treatments more accessible and effective for patients, she says.

PCI Pharma Services: Comprehensive Clinical to Commercial Injectable Delivery

Biopharmaceutical companies are ac­tively incorporating autoinjector drug de­livery technology into their product portfolios, recognizing the competitive ad­vantage these devices offer in terms of dif­ferentiation and patient satisfaction. As a result, the autoinjector market is witnessing a surge in innovation, with companies in­vesting to enhance device features and compatibility with a diverse range of bio­logic drug products.

Indeed, the growth in injectables is driven by biologics – which in most cases today cannot be effectively delivered orally – and the desired delivery is self-adminis­tration. Spanning the cycle from develop­ment to commercialization, PCI offers comprehensive, scalable injectable drug delivery solutions for large and small mol­ecule life-changing therapies. “Our inte­grated sterile drug manufacturing and injectable final assembly and packaging solutions support biopharma companies in optimizing dosing, and provide conven­ient, easy-to-use, patient-centric therapies to patients,” says Bill Welch, Executive Di­rector Market Development, Advanced Drug Delivery, PCI Pharma Services. “Our consultative methodology and extensive experience enable a flexible and agile ap­proach for our clients, ensuring the right solution for the patient to realize improved health outcomes around the world.”

Driven by innovation and patient-cen­tricity, PCI’s design and development ex­pertise, combined with device assembly and drug delivery packaging capabilities, offer flexible solutions for a diverse portfo­lio of conventional and specialty injectable drug-device combination products. PCI enables rapid growth of the drug-device combination product for both the sterile fill-finish (SFF) and the final assembly, packaging, and labeling of the drug-de­vice combination.

He says: “Clients are thinking about their drug-device strategy earlier in the de­velopment process, with many biophar­maceutical companies investing in research and development to not only en­hance device features and compatibility with a diverse range of large and small molecule drug products, but also introduc­ing and evaluating them as viable dosage forms earlier in clinical trials through par­allel development strategies.”

Meeting the exponential growth in the development and use of autoinjectors, PCI continues to invest in device-agnostic, in­novative, scalable, injectable combination product final assembly, packaging, and la­beling technologies for autoinjectors, pre­filled syringes, PFS with needle safety device, pens, and on-body injector (OBIs).

“Wearable OBIs are currently a small segment of the market when compared to pens, PFS, and autoinjectors, and can be generally divided between those that are “prefilled and preassembled” and those that require filling and/or insertion of the drug container at point of use,” Mr. Welch explains. Similar to autoinjectors, there is an emphasis on simplicity for the patient, as exemplified by the “peel, stick, and click” approach for prefilled and pre­assembled OBI. As a device-agnostics service provider, PCI offers final assembly or kitting, packaging, and labeling services for OBI, as well as SFF of the containers used in OBI.

“We have the scalability to handle the dynamic volumes of biopharmaceutical therapies, whether large or small, from early-phase clinical trials through to com­mercial supply of niche personalized med­icines to large, annual volume treatments,” says Mr. Welch.

Phillips Medisize: Pen Injector Appeals to a Range of Customers

The injection market is currently dom­inated by pen injectors for insulin delivery, but autoinjectors are becoming more com­mon and in a broader range of indica­tions. Each device type has pros and cons. Pen injectors allow the patient to adjust the delivered dose, critical for drugs such as insulin-requiring titration. Also, pen injec­tors enable multiple injections from the same drug container, reducing the cost per dose. However, they are considered more complex to use than autoinjectors. The rapidly evolving injectable GLP-1 market will impact the uptake of new devices, with single-use autoinjectors currently gaining popularity for their convenience. Sustain­ability considerations will likely drive the market towards multidose disposable pen injectors. Additionally, take-back schemes are being explored to reduce waste, but in the longer term, continued focus on reduc­ing waste will likely increase interest in reusable devices, explains Iain Simpson, Director of Business Development at Phillips Medisize.

Most of the pen injectors in the market have been developed by pharma compa­nies for specific drugs. “Phillips Medisize spotted an emerging need for a pen injec­tor with a familiar look and feel to existing pen injectors that could offer a platform to a wide range of customers,” he says. “In developing this solution, which we call Envoi, we also incorporated some new benefits into the design, such as shorter button travel, which makes it particularly suited to delivering larger doses and for patients with smaller hands.”

Envoi is a platform solution that offers a range of models suited to deliver a range of therapies, including insulin, GLP-1s, and hormone replacement. Henrick Leisner, Envoi Platform Manager at Phillips Medis­ize, says: The Envoi Pen has been designed to be patient-friendly, minimizing the risk of device failure due to misuse, and is suit­able for delivering a range of drugs, in­cluding high-concentration drugs. “Furthermore, it has been designed for highly automated, high-volume manufac­ture, enabling reliable and economically viable supply to the largest drug markets on a global basis,” he adds.

Phillips Medisize is also a leader in developing connected devices that accu­rately measure medication use, allowing a digital health intervention to be adapted in real-time to changing patterns of medica­tion use. Dr. Simpson explains: “Working with Bayer, we brought the first drug-device combination with a regulated companion digital service to market. Medication non-adherence is a big issue for the industry, resulting in lost pharma company revenue as well as higher medical costs and lower economic productivity. Non-adherence is a complex behavioral issue requiring per­sonalized and dynamic interventions, that is, adaptive to any patient’s current circum­stances. We are working with behavioral experts to develop connected health solu­tions that address this need.”

Portal: Fast & Easy Delivery of High-Viscous Biologics

Empowering patients to manage their own care at home can lighten provider workloads, reduce demand for expensive clinical services, and make adherence more convenient for patients. The Portal PRIME device is an easy-to-use, needle-free, reusable injector that digitally con­trols the administration of high-viscosity biologics and monoclonal antibody treat­ments.

“Typical biologic concentrations are ≤200mg/mL; with increased dose needs, there becomes a trade-off between con­centration, which leads to higher drug vol­ume or to higher viscosity,” explains Christina Mastandrea, Vice President, Clinical Research, Portal. “New drug deliv­ery systems are needed to handle high-vis­cosity drugs or higher volumes in a pa­tient-acceptable format.”

Portal’s PRIME device can deliver vol­umes up to 2.0mL at high viscosities (up to 1,200cP) in 0.6 seconds. It can be con­nected to patient apps or the wellness team to provide a more complete data picture. PRIME is well-suited for patients with a chronic disease who need to take subcutaneous injections on a regular basis.

Portal is expanding its portfolio to in­clude a needle-based Smart Syringe that retrofits standard 1mL or 2mL prefilled sy­ringes (PFS). “Similar to PRIME, this tech­nology leverages a high-powered linear actuator, sophisticated real-time control al­gorithms, and cloud connectivity that also offers a transformed and safer user expe­rience,” she says.

Ms. Mastandrea continues: “Connec­tivity and wearable devices must be de­signed with end users in mind. Clinicians are interested in easy access to relevant clinical data, efficient integration of the digital platform into the clinical workflow, and ultimately improved treatment out­comes. For patients, the application’s us­ability and design are important for initial adoption, as are the potential for fewer clinical visits and thus fewer co-payments along with reduced time invested in ap­pointments and travel to clinics. Portal con­tinues to improve its connectivity platform to ensure a seamless and informative ex­perience for both clinician and patient, and the platform meets the highest quality standards.”

Sanner Group: Supporting Drug Delivery System Development

The injectable drug delivery sector is pouring huge resources into expanding capacity for GLP-1s. These drugs were de­veloped originally to treat Type-2 diabetes, but have proven effective in treating obe­sity and, more recently have been shown to offer some protection against cardio­vascular disease. While most GLP-1 drugs are injected, oral GLP-1s, such as Rybelsus (semaglutide), are being developed. How­ever, sales of injected GLP-1s should con­tinue increasing for some time due to relatively infrequent injections and patient-centric injector designs.

Another trend is large-volume injec­tions. Multiple drugs have been or are being reformulated from intravenous infu­sion to subcutaneous injection. These ther­apies tend to require high-volume or high-viscosity injections, which has prompted the development of large-vol­ume autoinjector platforms and onbody delivery systems. The majority of “tradi­tional” autoinjector platforms are based on a 1mL staked needle. More recently, 2.25mL syringes have been supported and the increasing capability for larger vol­umes has been extended to 3mL in car­tridge-based autoinjectors.

A third trend is increasing innovation in ophthalmic injections. These have spe­cific development challenges because they have very low particulate limits, they must not draw fluid back up the needle, they must not increase intraocular pressure, they have small dose volumes and precise dose accuracy, and they must be targeted very accurately.

Autoinjectors offer increased usability over vial-and-syringe or prefilled syringe presentations. Vials require multiple user steps to transfer the drug into a syringe and then inject into the patient. “In many cases, the drug is lyophilized so the user has to reconstitute the drug, too,” says Tom Oakley, Vice President of Design & Devel­opment, Sanner Group. “These additional steps increase the risk of error and loss of sterility.”

He continues: “Prefilled syringes re­duce the number of user steps compared to vials, but they can be difficult to use, es­pecially if the drug has a high viscosity and/or high volume, of if the user has is­sues such as hand tremors, arthritis, or im­paired visibility. In addition, unless they have a needlestick protection system, the user risks needlestick injuries from prefilled syringes.”

Sanner supports companies in the de­velopment of drug delivery systems, taking them from initial requirements through de­sign and development, verification and validation, and into scale-up and produc­tion. “Within that process, safety, function­ality and design are equally important,” says Mr. Oakley.

One example is an ergonomically shaped “flange” (finger rest enlargement) for a prefilled syringe. This improved flange increases safety and ease of use due to its ergonomic shape and non-slip surfaces. These features are especially im­portant where injection accuracy is critical, such as ocular injections and in cosmetic procedures. He says: “Sanner’s optimized manufacturing process ensures that the flange achieves the smallest shot weights possible with two-shot molding.”

SCHOTT Pharma: Prefillable Polymer Syringe Simplifies Subcutaneous Infusion

Autoinjectors ensure consistent and reliable dose delivery. This is particularly important for the efficacy of treatments, especially in the case of chronic condi­tions. SCHOTT Pharma’s prefillable poly­mer syringe is designed to ensure precision and quality in dosing. This is par­ticularly crucial for biologic medications. Additionally, polymer syringe maintains the stability of the drug, ensuring its effi­cacy until it is administered.

The polymer syringe also features a user-friendly design, reducing the risk of administration errors. “This not only en­hances the overall user experience, but also contributes to patient safety,” says Nina Krautwurst, Global Product Manager Polymer Solutions at SCHOTT Pharma.

Furthermore, the polymer syringe can be customized to accommodate various viscosities and volumes, making it versatile for different types of medications and de­vices. She says: “This flexibility allows healthcare professionals to choose the most suitable option for their specific needs, ensuring optimal drug delivery.”

In line with the growing demand for eco-conscious medical devices, SCHOTT Pharma uses sustainable materials to minimize the environmental impact of its prefillable polymer syringe SCHOTT TOPPAC®. Additionally, SCHOTT TOPPAC can store drugs down to -100°C and is successfully used in combination with highly sensitive drugs such as mRNA.

“With SCHOTT TOPPAC, we ensure that people around the world can admin­ister their medications safely and easily,“ says Ms. Krautwurst.

By combining KORU Medical’s ex­pertise in pump systems with SCHOTT’s expertise in prefillable polymer syringes for large volumes, SCHOTT can help improve the market introduction of infusion thera­pies while simplifying the subcutaneous in­fusion of large quantities of medication. For example, one pharmaceutical client was developing a new biologic therapy that required precise, subcutaneous ad­ministration, she explains. They faced challenges with patient compliance and dosing accuracy using traditional syringes.

“The ergonomic and easy-to-use de­sign of our prefillable polymer syringe makes self-administration straightforward with the KORU system, resulting in higher patient adherence,” she says. “Also, the precision engineering of our syringe en­sured consistent dosing, which is critical for the efficacy of biologic treatments. Lastly, patients reported a more positive experi­ence due to reduced injection anxiety and ease of use, leading to better overall treat­ment outcomes.”

SCHOTT Pharma recently launched the cartriQ® platform of pre-washed, ster­ilized, and siliconized ready-to-use (RTU) cartridges, covering all relevant formats, from 1.5mL to 20mL, to safely inject cru­cial therapies at home. “As a RTU product, pharmaceutical companies can always ex­pect the same quality and have higher flexibility in production to actual market demand, ensuring a consistent supply of critical drug products,” says Robert Lind­ner, Global Product Manager Bulk & Ster­ile Cartridges at SCHOTT Pharma.

Most recently was the launch of 10mL cartriQ cartridges, which are suited for sensitive biologics. The containers are compatible with Ypsomed’s Ypsodose, making the fully assembled system the first on the market that is prefilled and pre-loaded, significantly reducing the handling steps for end-users, says Mr. Lindner.

Singota Solutions: Aseptic Manufacturing Tailored to Client Needs

There are several factors driving growth in the injectable delivery business sector. Many of today’s common diseases require injection of the therapeutic to avoid complications of the effects of the diges­tion system on the drug’s therapeutic ef­fects. New infectious diseases such as COVID-19 will require injectable vaccines.

Autoinjector technology offers many advantages. Self-injection via autoinjectors allows for improved dose accuracy and re­duced cost of administration. Design fea­tures provide benefits such as prevention of accidental activation, reduced needle stick accidents, and visual or audible indi­cators of dosage success. Autoinjectors are now being designed with mobile app con­nectivity that keeps track of dosing fre­quency and even providing reminders to patients to take their medication.

CDMOs can play an important part in the development of an autoinjector/therapeutic product. The for­mulation and fill-finish processes need to be compatible with the design of the au­toinjector. Material compatibility, container closure integrity, and product stability con­siderations are all necessary in moving a product through the development phases.

Singota Solutions is a CDMO dedi­cated to overcoming obstacles in the drug development pipeline. “Specializing in small-batch aseptic filling, aseptic manu­facturing solutions, and injectable formu­lation development, Singota offers comprehensive services designed to expe­dite the progression of clients’ products to­ward clinical trials,” says Will Powers, Senior Director of Business Development & Marketing for Singota Solutions. “Our GMP-compliant warehousing and 3PL operations ensure the integrity and safety of pharmaceutical products, including those requiring cold-chain pharmaceutical storage.”

Stevanato Group: Single-Use Autoinjector Features Versatile Design

A number of biologic therapies are now coming off patent so biosimilar com­panies are seeking platform products that offer low up-front cost and fast time to market. Novel therapies moving from healthcare settings to the home, mean­while, are accelerating the move towards self-administration and therefore increas­ing the demand for simple and proven in­jectable delivery systems to enable safe and effective self-administration. Whether managing a chronic condition or dealing urgently with a life-threatening allergic re­action, patients are playing an increasingly central role in their own medical care through the self-administration of essential drugs.

“Autoinjectors are proving popular because of their simplicity and ease of use which enables them to self-administer their therapies,” says Josh Gordon, Product Manager for Drug Delivery Systems at Ste­vanato Group. “And, they are becoming more popular with pharma and biotech companies because of their optimal deliv­ery solution that presents a proven user in­terface and efficacy balanced with a favorable cost of ownership.”

While maintaining the historically proven user interface of a 2-step autoin­jector for the patient, Aidaptus® is a single-use autoinjector with a versatile design that accommodates both 1mL and 2.25mL prefilled glass syringes in the same device form factor and, with no change parts, ac­commodates flexible fill volumes in the prefilled syringe, he explains. “These unique product features provide value to the pharma customer by offering class-leading flexibility and adaptability in the development and manufacturing of com­bination products. This is demonstrated when combination products have multiple dose volumes. Aidaptus allows the pharma to test a single device design in development and minimize final assembly recipes to execute in manufacturing and SKUs to commercialize.”

In addition to the value the product brings, the Aidaptus commercialization is supported by Owen Mumford and Ste­vanato Group’s joint collaboration that amplifies Aidaptus’ value to the pharma by bringing the full complementary capa­bilities of the two organizations to bear, Mr. Gordon says. “Leveraging Owen Mumford’s pioneering autoinjector expe­rience and expertise along with Stevanato Group’s integrated device capabilities, in­cluding primary container, device, manu­facturing, assembly equipment, and analytical services, provides a scalable and continuity of supply offering to the pharma industry. Supported by the Owen Mumford and Stevanato Group’s collabo­ration, the Aidaptus offers unique value and opportunity to support speed to mar­ket and consolidation in scaling and mar­keting combination products.”

Terumo Pharmaceutical Solutions: Packaging for Compatibility

There are more than 3,000 injectable drugs in the pipeline – many of which are sensitive biological drugs with potential stability challenges. Thus, primary packag­ing solutions must reduce drug-container interactions throughout the shelf life. In ad­dition, many biologic drugs in the pipeline are targeted towards smaller patient pop­ulations, which requires the manufacture of smaller batches even in prefilled sy­ringes (PFS) – without compromising on quality. Flexible filling lines in combination with ready-to-fill components like PLAJEX™ is the answer to address this trend, says Thomas Isaac, Global Product Manager, Terumo Pharmaceutical Solutions Division. Terumo works with external partners to en­sure compatibility of PLAJEX with autoinjec­tors and safety devices for an integrated solution.

Terumo also supports its partners at both the development and commercial phases. In one case, Terumo helped intro­duce a biosimilar product in an autoinjec­tor. “By integrating the manufacturing of primary containers with essential features for the biotech market, such as silicone oil-free barrels, along with a comprehensive range of services – including fill-finish, as­sembly with an autoinjector, and regulatory support – Terumo simplified the tradition­ally complex supply chain involving multi­ple players,” he explains. “This allowed the pharmaceutical company to focus on drug substance preparation. As a result, the biosimilar product in the autoinjector has been registered in Europe, the US, Japan, and many other countries.”

Providing the most suitable injection needle for a specific drug constitution, route of administration, and injection site can be paramount for treatment compli­ance and patient adherence. To ensure the immediate availability of all necessary el­ements for an uncompromised procedure, it is beneficial to co-pack the selected nee­dle with a treatment kit. To streamline automated co-packing, Terumo has devel­oped a comprehensive range of needles provided in primary packaging featuring an ergonomically shaped cap-case recep­tacle – the K-Pack™ range. These needles are designed to occupy minimal space and have round shapes for enhanced pick-and-place efficiency. They also feature color-coded, tamper-evident labels with 2D-barcode capabilities, accommodating all major automation technologies. Addi­tionally, the implementation of a full 360° camera inspection is essential for optimal packaging processes, facilitating device identification and inventory control.

Terumo has also developed hypoder­mic injection needles that meet the de­mands of long-acting drug placement. “Leveraging advanced cannula design and manufacturing capabilities, Terumo has marketed needles that enable the injection of larger medication volumes into the gluteal area,” says Mr. Isaac. “These nee­dles, which feature lengths around 51mm and thin-wall technology, are designed to enhance user and patient comfort through reasonable flow rates.”

Vetter: Thoughtful Consideration of Autoinjector Development

As chronic diseases rise, there is a re­lated spike in biologic approvals. This re­sults in a co-existence of blockbuster products and small-batch drugs devel­oped depending on the demand of the patient group. Many of these diseases re­quire regular injections and experience significant increase in demand.

In this context, patient centricity is be­coming a greater priority as many look for homecare solutions that allow for self-ad­ministration. This shift from intravenous (IV) administration to subcutaneous (SC) is prompting pharma and biotech customers to outsource based on the unique require­ments and lifecycles of their molecules.

Autoinjectors are rising in popularity, largely due to their intuitive functionality and ease of use, even for patients with lim­ited dexterity. As a result, it is much more likely for patients to adhere to their di­rected doses, which improves overall care. These devices have no readily visible nee­dle and use “push on skin” technology that often reduces patient anxiety. Unlike an in­jector pen, autoinjectors include needle-stick prevention as an added safety feature. As a form of prefilled syringe, au­toinjectors include a single dose that min­imizes the risk of incorrect dosing, even for patients with little training. With controlled injection time and speed, patients experi­ence less pain.

“There are multifaceted challenges in the injectable sector that we strive to ad­dress,” says Carolin Gruber, Product and Service Manager Primary Packaging and Devices, Vetter. “Large-volume injections, for example, are growing in popularity due to new molecules (e.g. mAbs) with high concentrations and a rise in home­care. As the industry shifts from IV to SC formulations, we are evaluating devices with volumes that exceed 2-3mL and new wearables that support patient self-admin­istration.”

Sustainability is also a challenge. As a high-consumption industry with high plastic production, Vetter is focusing on making smart and environmentally con­scious decisions as a responsible member of the value chain. This includes providing all-paper packaging solutions and dis­cussing the implementation of recycling streams without jeopardizing quality.

Finally, Vetter is working to include flexible manufacturing concepts to account for small batch sizes for rare diseases and personalized medicines, and the corre­sponding frequent changeovers required, says Ms. Gruber.

“As a full-service provider, long-term thinking is essential to get ahead of cus­tomer needs and serve as an experienced and strategic manufacturing partner,” she says. “Launching an autoinjector is a strategically, technically, and operationally complex process that requires thoughtful consideration every step of the way.”

West: ODBS Evolves to Improve the Patient Experience

Injectable drugs are the fastest grow­ing drug segment and the rise in biologic drugs requires innovation in drug delivery methods due to their complex molecular structure. Regulations continue to evolve with review times increasingly expedited, with approximately 76% of drugs getting approved on their first cycle in 2022. Ad­ditionally, there is a race between drugs targeting the same indication or therapeu­tic area, particularly in biosimilars, with CDER approving more than 53 biosimilars referencing 17 innovator biologics; 42 are currently on the market.

Chronic conditions require long-term therapy, which has facilitated innovation and increased advancements and im­provements in the patient experience. As therapies become more complex and shift towards self-administration, pharma com­panies are under pressure to bring novel devices to market that are intuitive and easy to use for patients. “It’s not only a matter of preference – regulators are lis­tening,” says Shari Krusniak, Director, Marketing Strategy, West Pharmaceutical Services. “They’ve started capturing the ex­periences, perspectives, needs, and prior­ities of patients as part of the FDA’s Patient-Focused Drug evaluation. Their goal is to give patients more of a say in drug development and evaluation.”

Device development is a complex process, and the delivery technology can hinder patient experience. “Knowing our customers face these challenges, we aim to support their development with services and solutions that drive better patient out­comes,” says Ms. Krusniak.

West developed the SmartDose® port­folio of on-body delivery system (OBDS) devices to offer patients with chronic health conditions, who require medication injections, a reliable, convenient, and easy-to-use method for home-based drug administration. SmartDose is available in both 3.5mL and 10mL, consists of a bat­tery-powered, wearable on-body injector with a separate, prefillable, polymer-based cartridge that is filled with the drug product. “The OBDS incorporates human factors and usability testing to deliver a truly patient-centric approach to self-ad­ministration,” says Gurmeet Singh, Senior Director, Business Development, West Pharmaceutical Services.

SmartDose OBDS was the first large-volume wearable to be approved as a combination product by the FDA, this tech­nology has since evolved with multiple generations, with the goal of improving adherence and patient experience across a range of dose volumes, explains Ms. Singh. The SmartDose 3.5mL and 10mL devices are now used with two separate globally approved therapies in the market.

Disclaimer: West’s SmartDose® on-body injector platform is not independently cleared or approved by any regulatory body for general healthcare professional or patient use, nor is it available for gen­eral commercial purchase. Its distribution and use are subject to applicable regula­tory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or bio­logical product. Compatibility with any particular drug or biologic must be con­firmed, and its ability to achieve the de­sired patient benefits must also be confirmed, on a case-by-case basis. Impor­tant product and safety information and warnings available on West’s website.

Ypsomed: A Range of Injectors for a Range of Indications

There is huge demand for pens and autoinjectors to support the market growth for once-weekly GLP-1 injections for treat­ing Type 2 diabetes and obesity (diabesity). The latest GLP-1 type drugs can be formu­lated for multidose injections from a pen or as a single injection from an autoinjec­tor. Ypsomed is positioned to provide both devices, depending on the marketing strat­egy of the pharma customer.

“Some of the early once-weekly ther­apies for GLP-1s for treating diabesity were based on an antibody fragment that was only available in an autoinjector,” explains Ian Thompson, Vice President Account & Business Development, Ypsomed. “Newer once weekly GLP-1 drugs are simpler peptides that can be formulated and adminis­tered using a multidose pen injector. For a one-year therapy, a patient needs only 13 pens containing 4 weekly injections com­pared to 52 single-use autoinjectors. In this case, the pen injector option is more sustainable, and we expect demand for pens to increase over time for GLP-1 ther­apies.”

Other key growth drivers include the number of new antibody and oligonu­cleotide therapies for treating autoimmune diseases, rare diseases, and new therapy areas such as neurology diseases and im­muno-oncology drugs. Demand is in­creasing for larger volume injections of high antibody payloads, which has led to the development of new platforms that de­liver up to 5mL handheld injections, such as the YpsoMate 5.5 and 5-10mL patch injections like YpsoDose.

Connected solutions are also pivotal. Ypsomed Digital Health provides pharma­ceutical companies with fully integrated digital solutions combining injection de­vices with comprehensive digital patient tools. “Our connected devices deliver sup­port for patients throughout the injection process and capture accurate and unbi­ased real-world data,” says Mr. Thomp­son. Key connected devices include SmartPilot for YpsoMate and the Ypso­Dose large-volume patch injector.

Pharma customers are seeking estab­lished platform-based pen and autoinjec­tor platforms that are sustainable and manufactured at multiple sites around the world as therapies become available glob­ally. “Ypsomed is working on processes and new products that will further reduce the device carbon footprint and both im­prove and increase recyclability,” says Mr. Thompson.

The company is focusing on the com­plete range of platform products and ex­panding its global manufacturing footprint in Europe, China, and North America. Manufacturing the UnoPen and YpsoMate at multiple sites globally reduces supply chain risks and the ability to manufacture locally is more sustainable. Ypsomed now has more than 70 products on the market and over 130 active customers with many new self-injection device launches planned.