USP General Chapter Design of Stability Studies for Biotechnology Product Development and Lifecycle Management

Published on: 

Sponsored Content

Up to speed on the latest requirements and strategies to help ensure biotechnology product stability? Join this webcast to understand the regulatory landscape and develop strategies designed to enhance speed to market and lean and agile product lifecycle management. Live: Wednesday, Oct. 9, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Oct. 9, 2020 Register free

Register free:

Event Overview:
Stability of biologics often proves rate-limiting for product development and market registration. Biotechnology or biological medicinal products are inherently complex, often requiring specialized technologies and procedures to ensure their quality, safety, and efficacy. One of the essential requirements for any medicinal product is that product stability is maintained throughout the product shelf life. In addition, the stability of the product must be assured from the moment it leaves the company until it is administered to the patient.  

This webcast introduces a new USP General Chapter that provides guidance and considerations specific to biotechnology product stability with a focus to streamline development programs and achieve sustainable commercial product expiries.

Key Learning Objectives:

  • Understand the regulatory requirements and expectations related to biotechnology product stability programs

  • Learn how to design stability strategies from preclinical to commercial lifecycle management

  • Discuss example designs for biotechnology product stability testing

Speakers: Camilla Santos, PhD, Director Product Quality, Amgen

Lori McCaig, PhD, Independent Consultant, Member of the USP Biologics Stability Expert Panel

Time and date: Wednesday, Oct. 9, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Oct. 9, 2020

Sponsor: USP

Register free: