In recent months, the FDA has increased its compliance focus on the regenerative medicine industry, vowing to crack down on illicit stem cell clinics and others advertising the untested use of human cell and tissue-based products (HCT/P). Here’s a breakdown of the 351 vs. 361 regulatory framework.
Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time-consuming and difficult for cell and gene therapy companies. As such, here are three ways to save time when reviewing an MSA.
By Herman Bozenhardt, Bozenhardt Consulting Services, and Erich Bozenhardt, IPS-Integrated Project Services
Expansions and renovations to existing biological facilities, and construction of new facilities, provide unique opportunities to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the third in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.