Achieving clinical quality for human iPSC generation and expansion

Human pluripotent stem cells (PSCs) and their derivatives hold great potential in regenerative therapies, and recently have been used in a number of clinical trials targeting various diseases.
 

In this webinar, Dr. Boris Greber will introduce the GMP-compliant induced pluripotent stem cell (iPSC) manufacturing workflow established by Catalent in addition to highlighting regulatory requirements and considerations surrounding the source material employed for reprogramming. He will furthermore elaborate on critical QC parameters to assess safety, genomic integrity, and pluripotency of iPSCs as a key starting point in ATMP production. Finally, Dr. Greber will discuss the concept of immune matching based on Catalent’s emerging library of HLA-homozygous GMP iPSC lines and provide an outlook for ATMP development based on ongoing differentiation projects.

 

Afterwards, Dr. Chao Sheng will introduce the established workflow at Miltenyi Biotec for GMP-compliant PSC expansion using the CliniMACS Prodigy^® platform and the iPS-Brew GMP Medium, which provides a ready-to-use solution for human PSC banking.

 

Learning Objectives