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.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.

In this expert roundtable, three experienced professionals from the rapidly evolving gene therapy field delve into the crucial assessment of AAV potency and its profound influence on the industry's progress.

In this expert roundtable, three experienced professionals from the rapidly evolving gene therapy field delve into the crucial assessment of AAV potency and its profound influence on the industry's progress.

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.