Cell-based bioassays (CBBAs) are an essential tool for drug development, from preclinical through commercialization and are crucial for monitoring drug manufacturing processes and ensuring the safety, efficacy and potency of pharmaceutical products. These products, particularly cell and gene therapeutics and advanced biologics, are inherently complex.
Therefore, CBBAs must be tailored to suit each program. Choosing the best methods for each modality and understanding the desired endpoints are critical to designing successful assays and keeping your program on track. This webinar will cover fundamental aspects of CBBA development:
- Method selection for different modalities with a focus on potency
- Understanding key aspects and pitfalls of assay development
- Case study on potency assays for antibody-drug conjugates
- Importance of a two-way partnership for ensuring speed and staying on track
Register for this webinar today to explore essential strategies for designing and developing successful CBBAs tailored toward the development of advanced therapeutics.
Speakers
Jung-Hua Yeh, PhD, Principal Scientist, Cell-Based BioAssay Department at Solvias
Jung-Hua Yeh earned her PhD in Immunology at Aix-Marseille University and received her postdoctoral training at Stanford University.
Prior to joining Solvias in 2023, Jung-Hua was the Scientific Lead of the CAR-Treg program at Sangamo, served as Principal Scientist for Prokarium (UK) in vaccine development and drug candidate selection for cancer treatment and was as a Scientist in drug discovery and PD biomarker translational/clinical science at Genentech/Roche.
At Solvias, she leads the BioAnalytical strategy for drug release testing (ATMPs and Large Molecules) and ensures regulatory compliance for the Cell-Based BioAssay Department.
Message Presenter
Dr. Reg Clayton, Head of Biosafety and Deputy Site Head, Solvias
Dr. Reg Clayton is the Head of Biosafety at Solvias and Deputy Site Head of Solvias, based in Hombourg, France. Reg has worked in various positions in the pharmaceuticals sector for around 25 years, including as a Project Leader for small molecule antivirals discovery at Johnson & Johnson, Belgium; as Principal Scientist for Virology in the Field Development group at BioReliance (Merck, Glasgow) and as a VP of Serology and Disease Screening in the medical devices sector. Reg is a subject matter expert in virology, infectious diseases and cell-based assays and holds a PhD from the University of Glasgow.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Scientists, Directors and Leaders in bioassay development
- CMC analytics and quality control departments who are responsible for the development and validation of analytical testing procedures
- Anyone interested in gaining more insight into the development of cell-based bioassays
What You Will Learn
Attendees will learn about:
- Importance of CBBAs in drug development
- Customization for complex therapeutics
- Navigating development challenges
Xtalks Partner
Solvias
Solvias helps innovative companies advance their path to commercialization with CMC analytical solutions powered by deep scientific expertise and a relentless focus on our customers’ success. With years of expertise in small molecules, biologics and cell and gene therapies, our talented subject matter experts have the know-how, creativity, and tenacity to solve even the most complex analytical challenges. Solvias offers comprehensive solutions from raw materials to drug products to final release testing as well as API development and manufacturing for small molecules. Customers have a single, trusted analytical partner for their entire development journey. Our five global facilities are strategically placed in biopharmaceutical hubs. We are GMP, GLP and ISO certified and conduct over 100 successful customer audits every year. We take pride in putting science and quality at the heart of everything we do, helping our customers bring better and safer products to market faster.
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