![[Podcast] How Can Cell & Gene Manufacturers Scale to Meet Demand-min](https://www.benchmarkproducts.com/wp-content/uploads/2023/09/Podcast-How-Can-Cell-Gene-Manufacturers-Scale-to-Meet-Demand-min.png)
In this episode of Exceeding Your Benchmark, Sumit Verma, Senior Vice President Global Strategic Manufacturing at Iovance Biotherapeutics, talks about the challenges faced by new biopharma startups and how cell and gene manufacturers can scale to meet demand.
![[Podcast] What Updated Annex 1 Regulations Mean for Sterile Manufacturing Companies in 2023-min](https://www.benchmarkproducts.com/wp-content/uploads/2023/09/Podcast-What-Updated-Annex-1-Regulations-Mean-for-Sterile-Manufacturing-Companies-in-2023-min.png)
Podcast Host Gabrielle Bejarano talked to Chris White, who is the Global Head of GMP at Adamas Consulting, about what’s new and different in Annex 1, and how sterile manufacturing companies and facilities can meet the regulations by the summer of 2023.
In pharmaceutical manufacturing, the presence of endotoxin poses a risk to final product quality and patient safety. This article will discuss what endotoxins are, how they can be detected, and how you can prevent contamination.
Jump to video discussion On August 25th 2022, the FDA alongside EMA jointly released its new Annex 1 regulations for sterile drug manufacturing processes, monitoring, quality control, and more. The revision has been 14 years in
After several years of delays, the EU and FDA are now doubling down on their efforts to force drug manufacturers to comply with Annex 1…
