Current approaches to genetic stability testing rely on a complex set of assays to meet ICH Q5B requirements, many of which have limitations in discovery power and sensitivity. Simplifying genetic stability testing requires a sequence-agnostic, bioinformatics-based approach to rapidly identify and determine both heavy and light chain genes and flanking regions, variant analysis, copy number, and vector integration events.
As a single-test alternative, we will discuss the Aptegra™ CHO Genetic Stability Assay as a faster, DNA-based, whole genome sequencing method providing maximum information in the context of ICH Q5B for clonal CHO-based expression systems.
In this webinar, we’ll explore:
- How the single Aptegra™ assay meets ICH Q5B requirements when compared to the traditional suite of genetic stability testing assays
- What makes a bioinformatics-driven whole genome sequencing (WGS) approach superior to traditional molecular methods
- The advantages of using a single NGS-based assay in manufacturing and production
Speakers
Leyla Diaz
Merck
Principal Scientist
Leyla is a principal scientist in field development services. She provides scientific and regulatory input in biosafety testing and characterization of biological therapeutic products. She has 17 years of industry experience in product development of therapeutic antibodies and assay development for large molecules and vaccines.
Haiwang Yang, Ph.D.
Merck
Principal Scientist
Haiwang Yang is a principal scientist who specializes in designing and implementing bioinformatic tools to support sequencing-based biosafety testing methods. With more than 18 years of experience as a bioinformatician, Haiwang has extensive expertise in NGS data analyses using various programming languages and tools. Haiwang obtained a Ph.D. in genomics from Nanjing University and worked as a visiting scholar, post-doctoral scholar, and research associate at multiple institutions, including the University of Chicago, the Chinese Academy of Sciences, the National Institutes of Health, and Northwestern University.
Alexei Slesarev, Ph.D.
Merck
Head of NGS Research & Development
Alexei Slesarev is the head of NGS research and development, leading innovation initiatives for contract testing services that support pharmaceutical developers and manufacturers from early development through drug manufacturing and release. He has spent more than 25 years working in the industry, helping to pioneer advancements in DNA topoisomerases, thermostable chimeric DNA polymerases, direct whole genome sequencing technology, and small molecule therapeutics. Alexei holds a Ph.D. in molecular biophysics from the Moscow Institute of Physics and Technology, is the author of 60 publications, and holds four US patents.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:30min
Language:English
Session 1:presented November 30, 2023
To continue reading please sign in or create an account.
Don't Have An Account?