ON-DEMAND Webinar
ADC Case Studies: Overcoming Challenges in Bioanalytical and CMC Characterization
Now Streaming On-Demand
Antibody-drug conjugates (ADCs) are a rapidly advancing class of biotherapeutics that combine the targeting capability of monoclonal antibodies with the cytotoxic potential of small-molecule drugs. In this webinar, we explore a series of case studies highlighting the critical bioanalytical testing and CMC characterization approaches necessary to support ADC development.
Key topics include the bioanalytical methods used to assess payload pharmacokinetics (PK), total ADC PK, antibody PK, and the detection of anti-drug antibodies (ADA). We discuss advanced CMC characterization techniques such as glycosylation profiling, assessment of purity using high-resolution mass spectrometry (LC-HRMS), potency testing through ADCC (antibody-dependent cellular cytotoxicity), drug-to-antibody ratio (DAR) characterization via LC-MS, and the quantification of residual impurities like DNA and host cell proteins (HCP).
The webinar provides an in-depth understanding of the analytical strategies employed in the clinical development and manufacturing of ADCs, offering insights into regulatory expectations and the role of these analyses in ensuring product efficacy and safety. Watch now to learn how integrated bioanalytical and CMC testing is vital for successful ADC development and commercialization.
Our experts will discuss lessons learned from their experiences and offer insight into the multiple stages of specific assays including critical reagents, regulatory standards, assay formats and timelines.
Jim McNally, Ph.D., Chief Scientific Officer, has an extensive background in bioanalytical assay development and program leadership spanning more than 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he led a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire/Takeda which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. in Viral Immunology from Louisiana State University School of Medicine in Shreveport, and a Post-Doctoral fellowship in Viral Immunology at University of Massachusetts Medical School.
Timothy Myers, Ph.D., Manager I, has more than ten years of bioanalytical experience and has held previous roles at BioAgilytix as a scientist and Bioanalytical Project Manager. He has extensive experience in development and validation of ligand binding pharmacokinetic and immunogenicity assays. Mr. Myers received his bachelor’s degree in Biochemistry at Virginia Tech and a Ph.D. in Biochemistry and Biophysics from the University of North Carolina at Chapel Hill.
Bryan Thacker, PhD, Scientist II, earned a MS in Bioengineering and PhD in Biomedical Sciences at the University of California, San Diego. Dr. Thacker has more than a decade of drug development experience. He led cell line and assay development at an early stage start up company for eight years before joining BioAgilytix. He currently leads CMC assay development and validation for drug potency and LCMS large molecule characterization.
Gregory Reynolds, Associate Director of Operations, provides strategic and managerial oversight of bioanalytical operations including overseeing bioanalytical method development, validation, and sample analysis in support of small molecule therapeutics, biomarkers and peptides by LC/MS/MS analysis, bioanalytical project management, and bioanalytical material/instrument management. Mr. Reynolds obtained his B.S. in General Chemistry from University of California, San Diego.
Sarah Crittenden, Scientist III/Bioanalytical Project Manager, develops and validates custom ADA, PK, and cLB NAb assays for a wide variety of molecules such as CAR-T, bifunctional fusion proteins, mAbs, transgenes, AAV, biosimilars, prodrugs, and ADCs while managing a team to support her assays in the lab. Sarah got her start in the bioanalytical world at a small CRO where she began in the lab running ELISA and MSD multiplex kits. After mastering the commercially available kits on both platforms, she gained experience developing and validating ADA assays. From there, she was promoted to the analytical team leader who was responsible for scheduling all the bioanalytical studies and related activities to the analytical research technicians. Sarah joined BioAgilytix more than six years ago. She earned her bachelor's degree in Chemistry from Meredith College in North Carolina.
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