Get Proactive With Your Stability Program
WEBINAR
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.
Merck
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.
Merck
Technical Consultant, Field Technology Management
Pamela Hamill, Ph.D. is a technical consultant supporting the BioReliance® Contract Testing Services, providing clients with scientific and regulatory advice for quality control testing of biological therapies and novel modalities. Pam was previously principal scientist overseeing clients' custom potency assay development. Prior to this, Pam managed diagnostic services at the Rabies Centre of Expertise at the Canadian Food Inspection Agency and performed post-doctoral studies at the University of British Columbia. Pamela has a Ph.D. in virology from the University of Glasgow.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:45min
Language:English
Session 1:presented December 9, 2021