To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.
Long- and short-term stability studies are a critical part of a product development program and are required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning, you may face additional hurdles.
Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel-style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency, and safety.
In this webinar, you will learn:
- Key considerations on when and how to effectively plan your stability testing program
- How to ensure the right selection of assays for your testing package
- How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Speakers
Greg Pirozzi, Ph.D.
MilliporeSigma
Senior Project Manager, Custom Projects
Greg Pirozzi has 30 years of biotechnology industry experience with more than 20 years in various project management and technology development roles. In his current role, Greg manages a broad range of client projects including analytical and molecular assay development, transfer and validations, as well as extensive stability studies covering bulk, final drug product, and cell bank materials.
Previously, Greg led a variety of drug development projects including biologics and viral vectors for oncology, cardiovascular, ocular, and infectious disease vaccines and therapies. Greg holds a Ph.D. from New York University Medical Center.
Pamela Hamill, Ph.D.
MilliporeSigma
Technical Consultant, Field Technology Management
Pamela Hamill is a subject matter expert for product characterization, providing technical, scientific, and regulatory support for clients and specializing in strategies to understand product critical quality attributes and the functional activity of biologics through the use of binding and bioassays.
Prior to joining the organization, Pamela managed a national Level III diagnostic lab and worked in academic research focused on innate immunity, novel host defense peptides, and the development of assays enabling analysis of viral proteases and antiviral drug screening. She holds a Ph.D. and M.Sc. from the University of Glasgow.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:45min
Language:English
Session 1:presented December 9, 2021
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