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.
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 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 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 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 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.”
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.”
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.
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.”
- Global Pharmaceutical Analytical Testing Outsourcing Market Size, Share, Growth Analysis By Service Type, By End User, By Application – Industry Forecast 2023-2030, SkyQuest Analysis, May 2023, https://www.skyquestt.com/report/pharmaceutical-analytical-testing-outsourcing-market.
- Using artificial intelligence in improving chromatography analysis, Chromatography Today, May 9, 2023, https://www.chromatographytoday.com/news/data-handling/57/international-labmate-ltd/using-artificial-intelligence-in-improving-chromatography-analysisnbsp/60366.
- Adoption of New Technologies: CDMOs Perspective, by Girish Basavaraju, PhD, Aug. 12, 2023, https://www.linkedin.com/pulse/adoption-new-technologies-cdmos-perspective-girish-basavaraju-phd/.
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