Abstract: In the iPSC derived cell therapy world, developing a suitable iPSC line is a key step, but not the only one.

Summary: Catalent has successfully addressed the challenges associated with plasmid DNA manufacturing by developing robust process and analytical platforms. Catalent’s approach involves a one-process-fits-all single-use (SU) manufacturing process in compliance with current good manufacturing practices (cGMP) standards.

Summary: Catalent offers extensive expertise in the bioproduction of plasmid DNA, from early stages of development to CGMP manufacturing to satisfy clinical and commercial needs.

This article discusses the development and establishment of Good Manufacturing Practice (GMP) compliant workflows for generating induced pluripotent stem cell (iPSC) lines and their differentiated progeny for cell therapeutic applications.

Catalent expert George Buchman, Ph.D., offers insights on key challenges with scaling up production for gene therapies, complexities in the supply chain, regulatory considerations and overall reflections on the industry, progress and future.

Summary: In this article, Catalent expert Victor Vinci discusses what strategies are being employed to accelerate product development and commercialization without compromising quality.

Summary: In this article, Catalent expert Rupa Pike to discusses the manufacturing requirements for a specific cell therapy gaining popularity: CAR T cell therapies.

Summary: In this article, Catalent commented on pricing and approval of advanced therapies.

Summary: In this article, Catalent's George Buchman was asked to respond and give insight into trends across cell and gene therapy and what we can expect to witness this year.

Summary: In this article, Catalent expert, Victor Vinci was asked to respond and give his insight into manufacturing platforms and how they will help drugmakers meet demands.