Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with a host of experts about artificial intelligence (AI) and the potential impact AI and machine learning may have on the global bio/pharma industry in the near future.

 is chief scientific officer for Biorelate—an AI platform company that provides data solutions to pharma companies

 is CEO of Qinecsa Solutions, which is a UK headquartered but international pharmacovigilance technology and services solution provider.

 is vice president of Regulatory Quality and Compliance, Arriello—a life sciences consultancy.

 is CEO of Autolomous, which uses smart technology to help ATMP manufacturers.

is COO of Unbiased Science and vice-president of the Medical Information Leaders in Europe (MILE).

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

Drug Solutions Podcast: Realizing AI’s Potential 

Pharmaceutical Technology sits down with Christian Dunne from ChargePoint Technology to discuss the key processing equipment trends in the bio/pharma industry.

A Greater Need for Containment: Processing Equipment Trends

Over recent years, the bio/pharma industry has experienced a variety of trends, such as an increasing prevalence of more complex molecules in the development pipeline, smaller batch sizes being manufactured, and a greater need for containment, which have led to new approaches and technologies being explored for manufacturing and development. For processing equipment in particular, Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology, believes that the increasing levels of containment have had the biggest impact.

“In part, [the changing levels of containment are] probably because of the better bioavailability of some of the drugs that are coming through, the doses seem to be a little bit smaller, and so we're getting much higher potency in what we're seeing in the industry than we used to many years ago,” Dunne says. It was more commonplace to see containment levels of one to 10 micrograms per cubic meter in the past, whereas now, more often than not, the industry is seeing less than a microgram and even into the nanogram levels of containment, he explains.

“Certainly, automation is very impactful on the industry at the moment, and that sort of rolls into robotics,” Dunne continued. Primarily, robotics were introduced into fill/finish operations, he notes, but now they are also being seen in oral solid dosage (OSD) technology as well, linking various (OSD) steps together.

Additionally, single-use technology is a key trend shaping processing equipment, Dunne specifies. “Obviously, you get a lot of flexibility with the single-use technology, and a lot of reduced risk in terms of the operator protection. But of course, it's got the added advantage of cost being a main driver for a lot of the companies like CMOs [contract manufacturing organizations].”

Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology.

Christian Dunne is director of Global Corporate Business Development at ChargePoint Technology—a pharmaceutical containment and aseptic processing specialist company. Christian has worked in the bio/pharma industry for 20 years covering oral solid dosage manufacturing through to sterile processing and fill/finish manufacturing.

Videos

In this exclusive Drug Digest video interview an industry expert discusses key trends impacting solid dosage drug development and manufacturing. 

Focusing on Solid Dosage Trends and Demand

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, 

Group, interviews Dr. Ali Rajabi-Siahboomi from Colorcon about solid dosage drug development and manufacturing. During the discussion, Dr. Ali will provide an overview of the solid dosage drug development and manufacturing sector, factors driving growth in the market, challenges facing companies and the shifts in demand, the evolution of coating design, and regulatory considerations impacting oral solid dosage development and manufacturing.

Ali Rajabi-Siahboomi is the vice president and chief innovation officer at Colorcon, based at the Global Headquarter, USA. Rajabi-Siahboomi has held various academic positions in Nottingham and Liverpool JM Universities in the UK before joining Colorcon as technical director, responsible for Europe, the Middle East, and Africa in 2000. His main research interests are solid dosage form pharmaceutics, pharmaceutical technology with emphasis on oral drug delivery systems, solubility enhancement to improve bioavailability, and consistency of drugs and bioequivalence formulations. He has published more than 300 articles, book chapters, abstracts, and patents and obtained his B.Pharm. and PhD in pharmacy from the University of Nottingham (UK).

This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

 Emerging Therapies and Targeted Delivery

 Advances in Small-Molecule Manufacturing

Drug Digest: Focusing on Solid Dosage Trends and Demand

Close-up of a microscope lens examining microarray slides, a crucial tool in genomic research and medical diagnostics | Image Credit: © Varunee - Stock.Adobe.com

It is well-known that developing a drug from the discovery through to commercialization is a costly endeavor, with market analysis showing that the average R&D cost to develop an asset for 2022–2023 was $2.3 billion (1). However, many drugs do not make it through to commercialization, in fact it has been reported that clinical attrition rates for drugs that have reached Phase I trials is as high as 90% of drug candidates (2).

As a result of the high costs and level of risk inherent with drug development, it is imperative that companies efficiently determine the safety and efficacy of their candidates, to minimize any potential failure. “Bioanalytical testing is essential in drug development because it ensures the safety, efficacy, and quality of pharmaceutical compounds through quantitative analysis of drugs and their metabolites in various biological matrices such as plasma, urine, blood tissue, [and so on],” asserts Sujata (Suzzy) Bhavekar, study director at SGS North America. “Early identification of side effects through rigorous testing can reduce development costs by up to 20% (3). Drugs with robust bioanalytical data are 50% more likely to gain regulatory approval (4).”

“Bioanalytical testing covers a range of techniques and technologies used to quantify drugs and their metabolites, or biomarkers, in biological media,” adds Iain Love, director, Chromatographic Bioanalysis & Discovery Sciences, Department of Chromatographic Bioanalysis, Charles River. “The concentration data generated through bioanalytical testing are important as they inform researchers on how long a drug stays in the body and the beneficial effects or otherwise while it’s in there. Knowing the concentration of drug candidates and understanding the levels at which the drug has positive or negative effects on the body is critical to drug development.”

Vital data on drug absorption, distribution, metabolism, and excretion can be gained through bioanalytical studies, which helps developers to determine dosing regimens, agrees Bhavekar. “Poor pharmacokinetics contribute to 30% of drug failures, highlighting the importance of accurate testing (5),” she says.

Additionally, bioanalytical studies help with biomarker discovery, which improves the success rate of targeted therapies by 25% and supports personalized medicines (6), Bhavekar continues. Furthermore, suitable bioanalytical testing helps ensure compliance with regulatory standards, including good laboratory practice (GLP) and good clinical practice (GCP). “Approximately 85% of drug applications meet approval criteria with solid bioanalytical data (7),” Bhavekar says.

“Regulatory considerations are extremely vital in bioanalytical studies to ensure compliance with international standards and facilitate successful drug approval,” continues Bhavekar. “Adhering to GLPs and GCPs is essential to ensure data accuracy, reliability, and reproducibility.”

“Bioanalytical testing is carried out according to strict inter(national) guidelines and quality management systems,” agrees Love. “Monitoring authorities translate globally recognized quality management systems into national regulations.”

At the national level, there are guidelines such as FDA’s guidance documents on bioanalytical method validation and immunogenicity (7,8) and the European Medicines Agency’s guidance on bioanalytical method validation (9), Bhakevar adds. “Compliance with 21 CFR [Code of Federal Regulations] Part 11 (10) is crucial for maintaining the credibility of electronic records and ensuring data integrity,” she says.

“In addition to these national regulations, bioanalytical studies are also carried out following the International Council for Harmonisation (ICH) M10 guideline,” confirms Love. In fact, EMA’s guidance on bioanalytical testing has been superseded by the ICH guidance (11), since its publication in 2022.

“The ICH M10 guideline provides a harmonized approach across various regions including the US [United States], EU [European Union], Japan, and other member countries [and] provides a robust framework for validating methods, focusing on precision, accuracy, selectivity, sensitivity, and reproducibility, thus enhancing global consistency in bioanalytical testing,” Bhakevar specifies. “These regulatory frameworks, including ICH M10 and FDA guidelines, form the backbone of robust bioanalytical testing, driving drug development toward clinical and commercial success.”

“Outsourcing partners are an increasingly important piece of the drug development puzzle,” notes Love. “Partnership with a bioanalytical provider can bring about several tangible advantages that can help get drugs to the patients who need them in the shortest time possible. This could be from simple access to appropriate analytical platforms to receiving advice on planning the development program.”

In terms of regulatory compliance, the right partnership with a contract research organization that complies with global regulatory standards can ensure that the bioanalytical data generated meets the relevant requirements, Bhakavar explains. “Comprehensive services [provided by a partner company], including method development, validation, and routine analysis, allow sponsor companies to focus on core R&D activities while relying on their outsourcing partner for specialized testing,” she says.

“Outsourcing partners are also likely to be able to apply experience gathered from across a broad portfolio of modalities and development scenarios that can inform program decision-making,” confirms Love. “More than ever, bioanalytical science is involved in shaping programs, so careful selection of an expert outsourcing partner is an activity that can bring about the significant benefits involved with an accelerated drug development program.”

There are also benefits in terms of the flexibility and scalability of operations that a partner company can provide for a sponsor’s needs, Bhavekar remarks. “Outsourcing provides flexibility in scaling bioanalytical operations according to project needs, from preclinical to late-stage clinical trials. This scalability helps manage resources efficiently and reduces the burden on in-house teams,” she says. “[Additionally], with large-scale facilities and automated processes, outsourcing partners can handle high volumes of samples, ensuring rapid data delivery and accelerating the drug development timeline.”

“[Furthermore], outsourcing partners invest in cutting-edge technologies and platforms, such as mass spectrometry and immunoassays, to deliver precise and reliable data, which may not be feasible for smaller companies to implement internally,” specifies Bhavekar. “Overall, outsourcing bioanalytical testing to a reputable partner can enhance the efficiency and quality of the drug development process, enabling sponsor companies to achieve their project goals more effectively.”

“There has never been a more vibrant time to be involved in bioanalytical testing. It’s sometimes a challenge to keep up with the innovation both from within the drug development industry and from supporting partners,” notes Love. “There have been, and continue to be, some hugely innovative therapies discovered and developed by the pharma and biotech sectors. At the same time, instrument and software manufacturers continue to push boundaries with what can be done to generate extremely powerful data in support of drug development.”

An area of great interest for Love is that of patient centric sampling (PSC), which is “the description given to a number of techniques and approaches that affords patients choice: choice on how a biosample is taken but also the choice of whether to provide biosamples in a clinical setting or remote from a clinical setting,” he says. “This enablement of decentralized trials is potentially the biggest and most impactful paradigm change in the clinical space for a long time.”

For Bhavekar, the many advancements that have been seen in the field of bioanalytical testing have helped to greatly improve the analysis of both small and large molecules in drug development. For example, she highlights the hybrid approach of combining ligand-binding assays with liquid chromatography coupled with tandem mass spectroscopy as a way of improving sensitivity and specificity of bioanalytical studies for both small and large molecules.

Platform approaches represent another advancement in the field, Bhavekar continues. “Enzyme-linked immunosorbent assay, plasmon resonance immunoassay, hybridization assay, immuno-PCR [polymerase chain reaction] assay, and the Meso Scale Discovery platform are widely utilized methodologies,” she says. “These platforms are highly specific and sufficiently sensitive, enabling the generation of controlled and customized data that meets regulatory compliance standards.”

Other advancements include chromatographic-based techniques for greater analysis of samples, circular dichroism and differential scanning colorimetry for the assessment of stability and structural changes in large molecules, electrophoresis to help with the separation of proteins and large-molecule characterization, and multiplex immunoassays to gain insights into complex biological samples, Bhavekar notes.

“The bioanalytical field is continuously evolving, with ongoing research into novel biomarkers, advanced detection methods, and personalized medicine approaches. Staying at the forefront of these innovations is crucial for maintaining a competitive edge in the industry,” concludes Bhavekar. “By focusing on [more than just the core] aspects, sponsor companies can leverage bioanalytical testing not just as a regulatory requirement but as a strategic tool for advancing drug development and achieving market success.”

1. May, E.; Taylor, K.; Gupta, L.; Miranda, W. 

Unleash AI’s Potential: Measuring the Return from Pharmaceutical Innovation—14th Edition

. Annual Report, Deloitte, April 2024.
2. Sun, D.; Gao, W.; Hu, H.; Zhou, S. Why 90% of Clinical Drug Development Fails and How to Improve it? 

 12 (7) 3049–3062.
3. Smith, J. and Doe, A. The Impact of Early-Phase Clinical Testing on Drug Development Costs. 

Pharmaceutical Development and Technology

 24(3), 225-233.
4. FDA. Drug Approval Statistics. 2022 Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases.
5. Anderson, J. and Smith, R. Impact of Pharmacokinetics on Drug Development. 

Journal of Pharmacokinetics and Pharmacodynamics

, 48(2), 123-130.
6. Johnson, R. and Lee, K. Biomarker Discovery and Its Role in Targeted Therapy. 

. Guidance for Industry, May 2018.
8. FDA. 

Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection

. Guidance for Industry, January 2019.
9. EMA. EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** 

Guideline on Bioanalytical Method Validation

 Title 21, 11 (Government Printing Office, Washington, DC) 241–246.
11. ICH. M10 

Bioanalytical Method Validation and Study Sample Analysis

Felicity Thomas is the Associate Editorial Director for Pharmaceutical Technology Group.


Vol. 48, No. 12
December 2024
Pages: 30–32

When referring to this article, please cite it as Thomas, F. 
Leveraging Advancements in Bioanalytical Testing. 

Articles

As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.

Leveraging Advancements in Bioanalytical Testing

Retro classic typewriter from circa 1950s with sheet of paper and aged books on wooden desk front aquamarine wall background. Nostalgic writer's work place concept. Vintage old style filtered photo | Image Credit: © BrAt82 - stock.adobe.com

 will be moving into its 36th year as a published industry resource. Over the course of the past 35 years, the magazine has undergone a variety of changes, such as updated page designs and the inevitable changes in staff, but our ethos of providing the highest quality, most pertinent content for our readership has always remained the same.

 was published back in 1989, which was the same year that the first guidelines on good manufacturing practices for the European bio/pharma industry were published (1). Since that time, the industry, and the European region as a whole, has undergone a huge amount of change—from novel therapies to new regulations and, most recently, a drive towards digitalization and the adoption of more automated approaches.

 has had the immense responsibility and pleasure to provide a comprehensive overview of the relevant trends that impact our readers daily lives. And an important aspect of being able to perform this task successfully is considering our readership’s habits over time.

Over the course of the past couple of years, we have been discussing the future of our publication and how we can best serve you, our readers, with a variety of industry stakeholders. Through these discussions, we believe that now is the right time for us to transition from print media and become a fully digital publication in 2025. So, in the new year, 

will be distributed as a digital publication that will not only include our technical articles and expert-authored columns but will also provide a host of new interactive elements and content for our readers.

I am thrilled to be able to steer the ship towards the digital world and hope you will find our new interactive format a useful experience. We invite you to share your thoughts with us on our new look and welcome your feedback on where we can improve our offerings further.

Our first digital issue will be published in February 2025, until then, have a great festive break and here’s to a prosperous 2025 and beyond!

1. EC. 50 Years EU Pharmaceutical Regulation Milestones. Public Health Infographic, 


Vol. 36, No. 10
November/December 2024
Page: 6

When referring to this article, please cite it as Thomas, F. New Year, New PTE. 

Aligned with our audience’s preferences, PTE will be a fully digital publication from 2025 onwards.

New Year, New PTE

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Swiss biotechnology company, Roche, has entered into a definitive agreement to acquire clinical-stage biopharmaceutical company, Poseida Therapeutics. The merger agreement was announced by Roche in a Nov. 26, 2024 company press release (1).

Under the terms of the merger, Roche will gain access to Poseida’s good manufacturing practice (GMP) manufacturing capabilities and its R&D assets, in addition to the programs and pipeline products that the companies are currently collaborating on. Assets that will be incorporated fully into the Roche Group on completion of the acquisition include allogeneic chimeric antigen receptor (CAR) T-cell therapeutic programs aimed at B-cell malignancies, hematologic malignancies, and solid tumors, among other things.

“This exciting acquisition will allow us to drive further progress in allogeneic cell therapy while leveraging the successful existing partnership with Poseida,” said Levi Garraway, head of Product Development and chief medical officer at Roche, in the press release (1). “We are very encouraged by the early clinical data, and this acquisition builds on our joint progress to catalyze the development of potentially first and best-in-class cell therapies in oncology, immunology, and neurology.”

The merger agreement between the two companies builds upon their existing strategic relationship that was initially formed in 2022 and was aimed at the development of off-the-shelf CAR-T cell therapies to address the unmet medical needs of patients with hematologic malignancies (2). Moving forward, Poseida therapeutics, Roche, and Genetech—a member of the Roche Group—will focus on delivering the next generation of off-the-shelf CAR-T cell therapies with higher potency and favorable safety at scale to be able to reach a broader patient population.

“Our interest in cell therapy is directly tied to our commitment to discovering and developing pioneering medicines with substantial patient benefit,” added Aviv Regev, head of Genentech Research & Early Development. “We are excited to bring together cutting-edge scientific approaches and expertise to tap into the full transformative potential of cell therapy.”

A tender offer will be provided by Roche to acquire all outstanding shares of Poseida Therapeutics’ common stock at a value of US $9 per share, which represents a total equity value of approximately US $1 billion. Both boards of Roche and Poseida Therapeutics have already unanimously approved the merger agreement. The transaction is expected to close during the first quarter of 2025 and is subject to the relevant closing conditions.

1. Roche. Roche Enters into a Definitive Agreement to Acquire Poseida Therapeutics, Including Cell Therapy Candidates and Related Platform Technologies. Press Release, Nov. 26, 2024.
2. Poseida Therapeutics. Poseida Therapeutics Announces Strategic Global Collaboration with Roche Focused on Allogeneic CAR-T Cell Therapies for Hematologic Malignancies. Press Release, Aug. 3, 2022.

The acquisition will provide Roche with access to Poseida’s GMP manufacturing capabilities and R&D portfolio assets, including cell therapy candidates.