SPECIAL FEATURE - Outsourcing Analytical Testing: AI Could Transform Analytical Labs

Largely driven by the complexity of biologics, biosimilars and personalized medicine development, the global pharmaceutical analytical testing outsourcing market is expected to reach $15 billion by 2030, almost doubling in growth from $8 billion in 2022.1 Stringent regulatory guidelines and specialized capabilities are also contributing to bio/pharma companies seeking to outsource an­alytical testing providers.

Some of these specialized capabilities include artificial intelligence (AI), which requires a depth of expertise and provides access to large quantities of high quality data. Industry insiders say the potential of AI to increase reproducibility and accuracy has the potential to transform analytical labs in the future. For example, AI can automate and streamline chromatography analysis by enabling property predictions of unknown samples based on previous data.2 The result is a reduction in time and labor required to analyze chromatography data and improve accuracy and reliability. The promise that AI holds in the pharma sector has experts valuing the market at $6.7 billion in 2030, up from $1.56 billion in 2022.3

This exclusive annual report from Drug Development & Delivery presents how today’s leading analytical testing service providers are taking advantage of AI and other types of automation and in­novative technologies.

Adare: Robust Technologies for More Efficient Drug Development

Personalized and tailored drug treat­ments escalate the complexity of drug de­velopment significantly, often demanding a departure from traditional methods used in conventional development. Analytical testing, therefore, plays a pivotal role in ensuring that these novel treatments meet the diverse and specific requirements of the medication. An example of this is a specialized device that Adare is currently working on with a customer. This device enables precise and adjustable dosing, even outside standard dose ranges, such as administering a 35mg dose when only 25mg and 50mg tablets are available, ex­plains Mike Markham, Associate Director, Analytical Sciences, Adare. This flexibility also allows doctors to modify dosages without issuing new prescriptions.

“Achieving such precision demands robust analytical testing, focusing on the exact particle size and shape that is crucial for the device’s functionality,” he says. “Our formulation scientists are employing highly controlled methods, particularly in analyzing particle size with greater accu­racy than usual.”

This need for robust analytical testing is amplified by the multiple active ingredi­ents contained in the formulation, with half used for immediate release and the other for extended release. This necessitated en­hanced testing procedures in both mate­rial characterization and chemistry, as each API needed precise control. “This ex­emplifies the increased robustness and specificity often required in analytical test­ing during the development of personal­ized and tailored drug treatments,” says Mr. Markham. “The demands of pharma­ceutical development are ever-growing, and analytical testing is evolving to meet those demands.”

One of Adare’s strengths is mastering available technologies, then thoughtfully applying them to overcome customers’ challenges, says Jason Brown, Analytical Science Manager, Adare. For example, the company recently utilized a unique micro-dissolution apparatus for a kinetic solubil­ity study. “This specialized tool, not commonly found at CDMOs, enabled us to swiftly assist the customer in selecting the optimal salt form for their drug devel­opment.”

Mr. Brown says that this not only high­lights Adare’s technological capabilities, but also underscores the importance to the industry of understanding and innovatively utilizing existing technologies. “As impor­tant as new technologies like AI are, just as important – if not more so – is gaining a deep understanding of technologies that already exist and applying them in unique and novel ways that benefit sponsors and their patients,” Mr. Brown says.

As a result, he says, in the future, an­alytical labs in the bio/pharma industry are expected to increasingly integrate ro­botics and artificial intelligence. AI in par­ticular will be instrumental in data workup, especially for tasks like chromatographic data interpretation and data summariza­tion. “We have been exploring these inno­vations and will continue to do so, but we also greatly anticipate ongoing advance­ments in automation, online collaboration, remote operations, and paperless work­flows. These developments, though less headline-grabbing than AI or robotics, have already significantly streamlined daily operations in analytical labs. We foresee these advancements continuing to evolve, further reducing operational fric­tion and shaping the future of analytical lab environments in a meaningful way.”

Catalent: Digitization & People Create High Quality Data

Catalent has supported the pharma­ceutical and biotech industry with inte­grated and stand-alone large-molecule analytical services. One example is a cus­tomer that recently came to our Research Triangle Park, NC, site because a CRO had been working with a validated cIEF method on the Maurice to look at charge heterogeneity. Over the course of 18 months of developing and validating the method and testing stability samples, it was found that the method was not reproducible.

“The CRO could not find a solution to make the method more reproducible, so the customer brought the method to Catal­ent to troubleshoot it and make it more ro­bust,” explains Joe Nawrocki, Associate Director, Catalent Biologics. “We accepted the challenge and purchased a Maurice instrument capable of CE-SDS and cIEF. With the instrument currently being on­boarded, we were able to take the method and accomplish the customer’s need in just one month. Once we complete the on­boarding of the Maurice instrument, we will perform method validation and stabil­ity testing.”

Luke Mercer, Bioassay Manager, Catalent Biologics, says that while platform analytical methods continue to have their place, there is increasing need for molecule-specific analytical development to support treatment advances. This fo­cused evaluation and optimization, when done properly, results in well-designed methods that provide robust data to progress these innovative treatments to patients. The use of robotics allows the standardization of these setups to mini­mize some of the human variables that are always present. This can result in less vari­ability across test occasions.

“Digitization of all processes has been underway for years and continues to ad­vance,” says Mr. Mercer. “We will continue to see advancements in this area to allow more instruments interfaced. People will always have a key role in analytical labs, but with a goal to simplify their workday. Through more efficient digital and instru­mentation design, we will allow analysts flexibility to have more time outside the lab while still generating high quality data.”

Cyclolab Ltd.: Facilitating the Separation & Analysis of Challenging Contaminant Pairs

Cyclolab is an all-around cyclodextrin research and development company, op­erating as a CRO for cyclodextrin-related services including:

  • development of products (pharma, cos­metic, food, agricultural industries);
  • offering custom synthesis of cyclodex­trins, fine-tailored for certain guest mol­ecules (like Sugammadex) or purposes;
  • performing pilot-scale cGMP-compliant manufacturing of cyclodextrins to be used as APIs or excipients in clinical studies or cyclodextrin-enabled formu­lations for the same purpose; and
  • all analytical tasks related to the above, under GMP (method development, val­idation, stability studies for formulation ingredients (APIs, cyclodextrins) and final products as well).

One of Cyclolab’s main activities in­volves the synthesis of Sugammadex (SGM) impurities. SGM is a gamma-cy­clodextrin derivative, indicated for the re­versal of neuromuscular blockade initiated by the administration of rocuronium or ve­curonium. “The intellectual property rights for this molecular entity have either re­cently lapsed or are approaching expira­tion,” says Dr. Erzsébet Varga, Head of HPLC Laboratory, Cyclolab Ltd. “Conse­quently, multiple manufacturers have ap­proached us seeking assistance in their respective developmental endeavors.”

Given the extensive array of potential reaction pathways, a multitude of impuri­ties can arise during the process. In the absence of precise information regarding these impurities, it becomes challenging to determine the optimal reaction pathway.

Cyclolab’s analytical department suc­cessfully assisted its partners in the follow­ing areas:

  • Identification of unknown impurities through a comprehensive approach involving High-Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and Nuclear Magnetic Res­onance (NMR): Initial analysis includes HPLC-MS examination of the sample with unidentified impurity followed by the assessment of the mass spectrum. “Subsequent to spectrum analysis, our validation process extends to NMR stud­ies to corroborate structural details,” she explains. “It is crucial to emphasize that NMR measurements demand a sample of adequate quantity and qual­ity for accurate analysis. To meet this prerequisite, we employed one of our HPLC equipped with an automated fraction collector, ensuring the precise and efficient collection of samples for subsequent NMR investigations.”
  • Development of an HPLC method de­signed for the effective separation of critical pairs: The structural characteris­tics of SGM may lead to the formation of isomers and racemic compounds during the production process. Dr. Varga says: “Utilizing our extensive in­ventory of over 100 HPLC columns, we are well-equipped to facilitate the sep­aration and analysis of challenging contaminant pairs.”
  • Analysis of products from alternative manufacturers: Given the uniqueness of these impurities, their presence enables the identification of possible starting materials and reaction pathways. This information can also assist manufactur­ers in making informed decisions.

“Presently, Cyclolab offers more than 30 Sugammadex-related impurities, ac­tively aiding manufacturers in navigating the challenges encountered during the for­mulation/development process.

Daicel: Partnering Approach with Generic Peptide Manufacturers

Successful development of a generic peptide drug product requires a high level of technical expertise, a deep understand­ing on regulatory requirements, and excel­lent planning. Similar to small-molecule generic medicine, peptide generic medi­cine has to be bioequivalent to the inno­vator drug and ensure the same biological effect with proper safety and efficacy. However, it can be challenging to prove the sameness for synthetic peptide drugs against the reference listed peptide drugs of rDNA origin. Several governing guid­ances are now available such as: FDA Guidance for Industry: ANDAs for Certain Highly Purified Synthetic Peptide Drug Products that refers to listed drugs of rDNA origin, May 2021; USP general chapter 1503: Quality Attributes of Synthetic Pep­tide Drug Substances; EMA guidelines on the Development and Manufacture of Syn­thetic Peptides, October 2023.

“It is very difficult for mid-size generic peptide drug manufacturers to equip themselves with advanced analytical infra­structure and expertise to fulfil the criteria for successful regulatory filings, and part­nering with a specialized analytical CRO is more efficient in many aspects,” says Dr. Ch. Lakshmi Narayana, FRSC, Managing Director, Daicel Chiral Technologies India.

Japan-based Daicel Corporation es­tablished an Indian subsidiary in 2008 and, in turn, developed an analytical test­ing facility in Hyderabad, India, which has a track record of successful inspections by the US FDA in 2016, 2019, and 2023.

“Daicel has rich experience, expertise and knowledge in designing analytical studies for DMF and ANDA filings of both small-molecule drugs and peptide drugs,” explains Dr. Narayana. Daicel analytical packages for peptide drugs include method development, method validation, aggregation studies, orthogonal methods for related substances by HRMS, primary and higher order structure characteriza­tion, bio-identity tests by cell-based bio as­says, and E&L studies. Further, Anand Khatavkar, Senior Director, Sales & Mar­keting, adds Daicel’s expertise in synthe­sizing well-characterized, high-quality peptide impurity standards is an advan­tage for generic peptide drug manufactur­ers partnering with Daicel.

Both Dr. Narayana and Mr. Khatavkar say that generic peptide drug manufactur­ers partnering with Daicel are privy to a range of analytical testing with faster turn­around and quick synthesis of peptide im­purity standards, together with timely updates and transparent communication.

ICON plc: Faster Data Turnaround is a Differentiator

ICON offers true one-stop-shopping experience that includes on-site manufac­turing and release of dosing drug product, a co-located clinical unit, and analytical testing facilities that cover all types of sam­ples, including chromatographic and lig­and-binding assays.

At ICON, multiple test facilities around the globe conduct clinical studies across all phases of development. This is currently demonstrated by analysts oper­ating analytical equipment from remote offices via secure networks, mainly for data processing. “Quality Control labora­tories responsible for the analysis and ul­timately safety of our manufactured medications are equipped with identical UPLC systems at several locations in both Europe and the United States to enable flawless communication across our oper­ations,” explains Suzanne Jansen, Head of QC Laboratory, ICON plc.

When it comes to focusing on techni­cally challenging aspects, various auto­mated sample pipetting robotics are employed globally that allow high-volume consistent workflows. “Pipetting robots are taking over the performance of repetitive lab activities and this approach indeed works very well for standard work with large numbers of samples,” she says. “ICON does, however, value the impor­tance of hands-on lab activities, especially when it comes to the highly specific needs of our clients who require a flexible ap­proach from our analysts, with the ability to rapidly change strategies when needed.”

Pharma/biopharma companies are always looking for faster proof-of-concept data, which enables them to invest in the successful compounds and kill those that are not effective or safe. However, clinical trial designs of early-phase studies have become more complicated over the last couple of years to include multi-purpose protocols. Ms. Jansen explains that both PK and PD parameters are monitored throughout the clinical trial and serve as input for the intended dose for the remain­ing cohorts of the clinical trial. Tailoring the dose of the IMP is, therefore, essential for meeting the endpoints of the clinical trial.

“Adaptive doses can be realized by on-demand manufacturing and pharma­ceutical analysis,” she says. To allow the dose to be adapted, a dose range and/or concentration needs to be manufactured and analyzed. The analytical method re­quires validation (or bracketing) of all pos­sible doses in advance of the trial. PK/PD data may show that the formulation is not suitable for the drug substance used and lead to a non-linear bioavailability or an unexpectedly low or high bioavailability. A new formulation may then be needed, which calls for a rapid turnaround of the manufacturing method and analysis.

“The future analytical laboratory must be specialized in this quick turnaround,” she says. “The ability to serve the client with high quality analysis within a short timeframe will become the differentiator between pharmaceutical laboratories.”

Lifecore Biomedical, LLC: Pivoting Toward Technologies That Reduce Turnaround Time

Lifecore predicts there will be a need for higher throughput, which is leading the company to pivot toward more plate-based assays, automation options, and rapid microbiological testing technologies to reduce turnaround time. “Growth in the biologics market will result in greater need for cell-based assay capabilities and the development of platform methods,” says Jessica Raddatz Hensley, Quality Control Director at Lifecore. “In addition, the de­velopment of alternative technologies for pyrogen detection is a new area of focus for the industry.”

Lifecore’s analytical testing team re­cently identified unexpected degradation of a client’s development-stage product through our comprehensive stability serv­ices program. The assay and impurity data the analytical team provided allowed Lifecore to assist the client in optimizing their formulation to extend the shelf life of their product.

“We used our experience in handling viscous formulations to develop a biobur­den test method for a client whose previ­ous contract lab was not able to work with their material successfully,” she describes. “Lifecore’s microbiologists also overcame challenges posed by the viscosity and tur­bidity of the sample to develop a kinetic chromogenic endotoxin assay that has greater sensitivity than the gel clot method­ology used previously.”

Anticipating that the regulatory focus on data integrity controls will continue to increase, Lifecore Biomedical is prioritizing investment in electronic laboratory infor­mation management systems and auto­mated data transfer from analytical equipment. “The investment in paperless technology will also provide the enhanced transparency clients are seeking, allowing us to have more data and metadata read­ily available for custom reporting,” says Ms. Raddatz Hensley.

Lonza: Systems to Enable Remote Access for Data Analysis

Lonza recently deployed Native Ion­ization MS (mass spectrometry) linked to Protein A affinity chromatography. Titer by protein A is a well-established and robust method, deployed for many programs. This method was developed to generate structural information on bispecific assem­bly alongside titer. The combination al­lowed high throughput screening of clones for both assembly and titer simultaneously, directly from the culture supernatant.

“The outcome of this innovation is that we can deliver additional key informa­tion to support decision making without extending timelines,” says James Graham, Director, R&D, Protein and Process Analyt­ics, Lonza.

Historically, MS data processing has limited productivity, often taking longer than sample preparation and data acqui­sition combined. To that end, he envisions a future where systems will enable remote access for data analysis and effectively de-bottleneck a task that previously relied on the availability of a limited number of physical workstations. Remote analytical technologies are predominantly based around instrument control and, critically, data processing. This includes chromatog­raphy data systems, and more recently has become very important for processing of high-resolution mass spectrometry.

Robotics are currently in use for sev­eral analytical platforms. Predominantly, they are used for sample preparations, but in some cases also for end-to-end execu­tion of analytical procedures, resulting in higher standardization and cost savings. This also allows scientists to focus on the development of new methods that are re­quired for new molecular formats, rather than rote execution of platform methods. Machine Learning models are now being developed and used to improve cell lines and processes.

“We at Lonza believe analytics will be­come far more integrated into the overall process,” he says. “Scientists should be able to generate robust analytical results quickly and easily by themselves, at the point of need, rather than having to hand off samples and information to a different department. This change requires both method simplification and substantial lev­els of automation.”

This is already the case within the R&D organization, he adds, where analyt­ical instruments are sitting alongside bioreactors for at-line testing. “In the fu­ture, the role of analytical scientists will be much more focused on method develop­ment/transfer and oversight of the analyt­ical platforms. Therefore, analytical labs will focus on more advanced applications and instruments, rather than containing banks of HPLCs for routine testing.”

MedPharm: Increasing the Robustness of IVPT Experiments

In vitro penetration/permeation test (IVPT) is a well-validated tool for the study of the pharmacokinetics of topically-ap­plied drugs. The model uses excised human skin mounted in specially designed diffusion cells that allow the skin to be maintained at a temperature and humidity that match real-use conditions. The prod­uct/formulation is applied to the skin’s sur­face, and the compound is measured by monitoring its rate of appearance in the receptor solution underneath the excised skin. This model also allows the amount of the drug and metabolites within the differ­ent layers of the skin to be measured (i.e., epidermis or dermis). Additionally, this model has the potential for carefully con­trolling many of the variables involved in topical application, like dosing volumes, humidity, temperature, drug stability, skin thickness, etc.

According to Dr. Jon Lenn, Chief Sci­entific Officer at MedPharm, the most common commercially available diffusion cell systems are tedious and manual, which take hours to set up, require scien­tists to manually sample at designated time intervals (sometimes in the middle of the night), and require constant monitoring to ensure air bubbles are not introduced.

“To combat these challenges, we de­veloped a fully automated diffusion cell system (MedFlux-HT®) that uses peristaltic pumps, robotic sampling rails, optimized fluidics, and computer-controlled sample collection,” he explains. “The modification in the fluidics and automation of the sam­pling has allowed sample collection to occur simultaneously across 96 diffusion cells at 15-minute increments, which is not technically feasible with the commercial systems. The system has transformed the analytical testing to ensure accuracy of highly lipophilic drugs at sub-nanogram levels and a better characterization of the pharmacokinetics of topically-applied products.”

In addition, the system has a fully in­tegrated transepidermal water loss (TEWL) instrument that measures the integrity of the skin’s barrier across 32 diffusion cells simultaneously taking multiple readings each minute. The TEWL ensures the accu­racy of the data by allowing for skin that is damaged or has a defective barrier to be removed prior to experimentation.

Dr. Lenn says that MedFlux-HT is routinely used for R&D and regulated IVPT experiments during formulation develop­ment and optimization, and generic prod­uct approval in lieu of clinical trials. He says: “This system has decreased the work­load by about 80%, increased efficiency by several hundred percent, and increased the robustness of IVPT experiments.”

MilliporeSigma: Evolving Workflows for More Vigorous Personalized Drug Testing

Robotic technologies represent a growing industry trend because they en­able faster initiation of analytical testing and deliver consistent performance with low error rates. MilliporeSigma is integrat­ing these technologies into its contract test­ing services and currently employs robotic technologies across laboratories for virol­ogy, immunology, molecular, and more.

According to Brian Woodrow, Global Head of Operations for Product Charac­terization at MilliporeSigma, analytical testing teams: employ robotic pipetting in­struments in cell culture activities to in­crease accuracy and volume consistency from well to well; apply Machine Learning (ML) technology for automated cell count­ing and cell confluency determination; and utilize Artificial Intelligence (AI) for auto­mated cell monitoring, aiming to eliminate variability with manual cell confluency de­termination, reduce lab time, and increase cell count accuracy.

He says: “This all contributes to en­hanced data reproducibility and increased efficiency for cell-based assays.”

Looking ahead, analytical testing in the future will need to re-work workflows and become more robust to drive high throughput, one-off testing for personal­ized medicine. Fundamentally, personal­ized medicine involves developing a single drug tailored to a patient’s needs.

“This demands rapid turnaround and, often, specialized testing,” he says. “Our teams are determined to help realize the promise of personalized medicine by driv­ing adaptation of testing approaches. We continuously apply operational excellence principles to conduct step-by-step deep dives into workflows across our laborato­ries that offer analytical testing for person­alized therapies. From lab operations to report writing, quality assurance and more, we seek opportunities to optimize processes, improve turnaround time, and further specialize offerings.”

Based on current industry needs, Mr. Woodrow is certain that small molecules will continue to be relevant, while medicine based on biologics will thrive. Many bio­logic-based therapies demand faster turn­around time – within weeks or days – before administration to patients.

“Time does not allow for retests, as patients are scheduled for injections of en­gineered therapies within a pre-set time­frame,” he says. “Therefore, analytic testing providers must achieve two key per­formance indicators: on-time delivery (OTD) and right first time (RFT). These measures will become more decisive in the move from bulk-based to personalized medicine.”

PCI: New Technologies Will Enable ESG Manufacturing

New technologies, artificial intelli­gence, robotics, and automation will play a significant role in the future state of analytical laboratories. The focus will be on less lab-to-lab, scientist-to-scientist, sys­tem-to-system variability ensuring accu­racy and consistency from one test to another, as well as faster data analysis to support formulation development and process optimization studies.

“Currently, Artificial Intelligence tech­nology in analytical laboratories is not well established,” says Lauren Parry, Director of Analytical Services at PCI’s high potent manufacturing facility in Wales, UK. “Au­tomation is certainly on the increase from automatic pipettes through to dissolution and HPLC autosamplers as standard.”

She says this means the equipment can perform the analysis without the sci­entist around, which provides more con­sistency in the test execution and less scientist-to-scientist variability as well as al­lowing the scientist to work on a separate task in parallel. However, in the develop­ment phase of a product, observing how a finished product behaves in a dissolution vessel, can be value adding.

While solutions, samples, and system set-up do need to be performed on site within the laboratory, it is possible to con­trol HPLC instrumental analysis remotely through software. This includes system purging, column equilibration, system suit­ability execution, and launching of data analysis. The analysis can be monitored remotely and data processing of the ac­quired data can also be performed once the analysis is complete.

“The future analytical laboratory will be fully digital with end-to-end connected instrumentation capable of measuring, trending, and reporting of data with AI so­lutions to detect errors and resolve real-time without user intervention,” says Ms. Parry. “New technologies will form part of the Environmental, Social, and Corporate Governance utilizing alternatives to plas­tics and single-use consumables and re­newable solvents.”

Recipharm: The Future Lab Combines Automation & Technological Innovation

Recipharm embraces innovation and incorporates cutting-edge technologies into its laboratory practices, with an initial focus on incorporating robotics into its workflows. All analytical tools have been upgraded, swapping out manual work for automated processes.

The company’s analytical processes predominantly rely on chromatography, such as high-performance liquid chro­matography (HPLC), ultra-performance liquid chromatography, and gas chro­matography, supported by suitable soft­ware. Automated sample preparation techniques help to accelerate the analysis of samples compared with manual sampling and dramatically improving productivity.

“Automating these analyses enabled remote monitoring during the pandemic, allowing us to summon a limited number of analysts to the lab in a staggered man­ner to perform essential wet lab tasks like sample and standard preparations,” ex­plains Ramesh Jagadeesan, PhD, Vice President, Analytical Development, Recipharm. “The valuable experience gained from navigating these unforeseen chal­lenges continues to inform our approach in the current scenario.”

Another example of how robotics has influenced Recipharm’s analytical technol­ogy is its automated robotic diffusion sys­tem for in vitro release testing (IVRT) of semisolid dosage forms. The system auto­mates sampling, improves time efficiency, increases consistency, and prevents acci­dental contamination, ultimately making analytical testing more efficient.

Combined automation techniques, such as robotics and AI solutions, will allow analytical systems to perceive mis­takes or non-ideal conditions and make real-time corrections. As exemplified in a client project, Recipharm adopted innova­tive approaches in equipment design and integration. Dr. Jagadeesan explains: “We were approached by a sponsor to produce a method for low-dose dissolution testing of an active corticosteroid component in a topical solution. As this was not compatible with traditional dissolution methods, we had to devise a new approach. Chal­lenges stemmed from first adapting the traditional United States Pharmacopeia 2 dissolution apparatus for small volumes and developing an HPLC method with the capability to detect very low concentra­tions. In making these customizations, we could test with smaller sample volumes and reduce receptor fluid volume, leading to a higher concentration for quantification via analytics.”

The future analytical lab envisages advanced instruments for intricate proj­ects, necessitating the integration of multi­ple instruments with diverse working principles for immediate results. Analytical labs need to adopt more automation tech­niques and utilize technological innova­tions to speed up projects. Recently, Recipharm has provided analytical serv­ices related to the reverse engineering of a reference-listed drug (RLD) with an aerosol formulation. The client wanted to develop a generic formulation and wished to submit the Q1 and Q2 details to the FDA for approval. Dr. Jagadeesan says Recipharm sourced three different lots of RLD samples from the US market and an­alyzed them using a method developed in-house. The excipient content was quantified (±5%) and the client submitted a complete report within a very short time.

“Fast-tracking therapeutics is a com­mon goal that helps expedite time-to-mar­ket and allow patients to receive vital medicines sooner,” he says.

Stevanato Group: Mechanical and Closure Integrity Testing for Optimal Packaging

Pharma companies often choose a readily available drug container in a bid to accelerate the time to market for their drug product. But they risk encountering problems at the last minute if they have not thoroughly vetted the container right at the start.

“One of our US customers used a Ste­vanato Group’s Technology Excellence Center (TEC) to evaluate a range of glass and polymer syringes and elastomer stop­pers to identify which container combina­tion was optimal for their unique drug product,” says Alan Xu, Product Manager, Analytical Services, Stevanato Group. “The TEC was able to perform a range of me­chanical and closure integrity testing to identify which syringe combinations were strong candidates – and which ones should be dropped from the evaluation.”

Root-cause analysis is also a key serv­ice offered by Stevanato Group’s TECs – for example, identifying unknown fibers or components. Breakages and other quality issues are a constant challenge for pharma companies, so evaluating poten­tial root causes with TEC’s glass fractog­raphy or forensic service has been crucial, Mr. Xu says.

Preparing for FDA submissions is an­other critical service offered by the TECs – evaluating whether glass container per­formance has changed over time, for ex­ample. “Several of our customers have requested validated testing in anticipation of follow-up questions from the FDA, so having the data early brings peace of mind – both in terms of characterizing the product and also being able to respond to the FDA in a timely manner.”

Concentrating a variety of different services under one roof – as Stevanato Group does – is a trend that is likely to continue in the future. “Offering multiple services as a one-stop-shop provider reduces logistical overheads and the time between tests, as well as the risk of confounding variables,” says Mr. Xu. “The drug product, drug container, and drug delivery system can all be analyzed in the same place and benefit from economies of scale, particularly when it comes to automated testing.”

Automating services such as data collection, tracking sam­ples, environment monitoring, equipment maintenance, and cal­ibration schedules allow laboratories to minimize scheduling issues and keep projects running smoothly. Laboratory Informa­tion Management Systems (LIMS) and electronic lab notebooks are becoming increasingly popular to centralize traceability.

Combining multiple tests to be run by the same machine is also starting to happen – to minimize the human element of shift­ing samples from machine to machine and reducing total sam­ples needed, he says. There are already automated drug delivery device testing machines, for example, that simultaneously test and record multiple performance features, ranging from activation force to sound to dose accuracy. “This is set to become common­place in the future, as it delivers faster throughput and more con­sistent results.”


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