As advanced therapies progress through the clinical pipeline, the integrity of the materials used during manufacture becomes increasingly critical.
TORONTO (PRWEB) February 24, 2021
As advanced therapy developers approach approval and commercialization, they adopt increasingly robust risk-based approaches to ancillary material qualification. Ancillary material qualification is defined by USP 1043 as “the process of acquiring and evaluating data to establish the source, identity, purity, biological safety, and overall suitability of a specific ancillary materials.”
As advanced therapies progress through the clinical pipeline, the integrity of the materials used during manufacture becomes increasingly critical. This session focuses on the challenges that human blood-derived ancillary materials pose, and on the strategies employed by suppliers to mitigate the potential risks they present.
These include extensive donor-screening practices and testing for infectious transmissible agents, the application of current good manufacturing practices (cGMP) during production, and the implementation of robust safety testing on the finished products. In addition, the implementation of virus inactivation processes offers an additional layer of safety as well as lot-to-lot consistency.
Join Robert Margolin, Vice President of Global Sales, Akron Biotech; Richard McFarland, PhD, President, Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) & Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI); and Raymond Luke, Associate Director of Process Sciences (Manufacturing Science & Technology), Adaptimmune in a live webinar on Thursday, March 11, 2021 at 1pm EST.
For more information, or to register for this event, visit De-risking the Manufacturing of Cell Therapies through Virus-Inactivated Products.
ABOUT AKRON BIOTECH
Akron is a leading materials manufacturer and services provider to the regenerative medicine industry. An ISO 13485-certified company operating in line with cGMP guidelines and international standards, Akron leverages more than 100,000 square feet of development and manufacturing capacity to provide advanced therapy developers the scale, compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization. For more information, please visit http://www.akronbiotech.com.
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