Changing Landscape of QC Testing for Emerging Therapies

WEBINAR

Key process goals are maintained to achieve scalable processes to ensure the reproducibility of the product. Market growth and application of emerging therapies have intensified the need for applied approaches to general safety, characterization, and efficacy testing that improves upon well-established techniques and streamlined testing. We provide an analysis of the current regulatory requirements for these molecules as well as the industry landscape and testing challenges. The use of state-of-the-art techniques to improve and expand existing testing processes to examine process product-related impurities, characterization, and viral safety provides a level of both safety and quality assurance that address current regulatory expectations.

In this webinar, you will learn:

• The definition of emerging therapies and the regulatory guidance for such therapies
• Traditional product characterization and biosafety methods and future scientific principles
• Case studies to provide experiences of successful regulatory submission