Product and process impurities in biopharmaceuticals are often present in very low abundance and are often “lost in the noise,” making their analyses quite challenging and time-consuming.
In this webinar, learn about a novel mass spectrometer-based approach that can speed detection and quantitation while achieving the required specificity and sensitivity—and how multiple reaction monitoring (MRM) techniques can be effectively applied to CMC-related development activities.
Case studies will be cited to demonstrate how internally standardized LC-ESI-MS/MS methods can be designed and validated to meet regulatory requirements.
Rowel Tobias, Ph.D., Senior Scientist, Protein Chemistry, ABC Laboratories
An accomplished protein chemist with over 20 years of bioPharmaceutical industry experience, Dr. Tobias is ABC’s technical lead for CMC Method Development and Validation for therapeutic proteins, antibodies and biosimilars. He has in-depth experience in analytical characterization, release and stability testing for monoclonal antibodies, complex glycan analysis, and has developed a novel approach to post-translational modification analysis by mass spectrometry to support regulatory submissions and clinical studies. Prior to joining ABC, Dr. Tobias worked as a research scientist and study director for various biotherapeutics and diagnostic companies, where he contributed to numerous FDA submissions. Dr. Tobias’ work has been widely published, and he is co-inventor of a single-chain polypeptide diagnostic marker for myocardial infarction.
John Anders, Ph.D., Head of Quality Control, Nanotherapeutics, Inc.
Over the past three decades, Dr. Anders has been instrumental in the development of scores of recombinant proteins, therapeutic antibodies, antisense oligonucleotides, biosimilars and genomic medical devices. A retired Major in the U.S. Army Medical Research and Development Command, Dr. Anders served for many years at the Walter Reed Army Institute of Research and the U.S. Army Medical Institute of Chemical Defense at Aberdeen Proving Grounds, Maryland, where he pioneered numerous vaccines and drugs to fight parasitic disease, and helped develop countermeasures against chemical and biological threat agents. An accomplished researcher and publisher, Dr. Anders subsequently served as laboratory director for two contract research organizations supporting the development of bioPharmaceuticals. While Vice President of lab operations at Gene Express Inc. he led a team in development of several genomic-based diagnostic and companion tests for subsequent approval as medical devices. Today, Dr. Anders is the resident Senior Scientific Advisor at ABC, and assists clients worldwide in the development and regulatory requirements of biotherapeutic products.
Who Should Attend?
Scientists involved in biopharmaceutical development or manufacturing, or anyone involved in outsourcing these services
ABC Laboratories provides IND-enabling, registration and post-commercialization support for the development, quality control and lifecycle management of large and small molecule drugs, medical devices and combination products. The company employs nearly 400 scientists and support personnel, and supports all stages of drug development with GLP and CGMP-compliant analytical testing services across all types of active Pharmaceutical ingredients and formulations. Our personalized, results-based approach to doing business is backed by drug development know-how, cross-disciplinary technical expertise, and applied experience with multiple regulatory frameworks. ABC delivers the kind of insight that drives better outcomes.