Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
Manufacture Advanced Medicine

Entering the Industrial iPSC Era

Shinya Yamanaka’s groundbreaking invention of reprogramming human somatic cells into induced pluripotent stem cells (iPSC) has not only impacted the field of drug discovery, toxicity testing and in-a-dish disease modeling, but also profoundly revolutionized the field of cell and gene therapy. The capacity of iPSCs to expand in vitro andthen differentiate into specialized cells (which is to say, directed differentiation into any cell type in the body) as per user needs makes iPSCs a promising and unlimited cell source for curative clinical cell replacement therapies and disease modeling. The advance has led to a growing demand for high quality tissue and pluripotent stem cell-based therapeutics.

Over the last decade, several clinical trials using iPSC-derived specialized cells have been planned, including: mesenchymal stem cells for the treatment of steroid-resistant acute graft versus host disease/GvHD; dopaminergic progenitors for the treatment of Parkinson’s disease; natural killercell-based cancer immunotherapy for the treatment of advanced solid tumors; retinal pigment epithelial cells for the treatment of age-related macular degeneration (AMD); insulin secreting beta cells for the treatment of type I diabetes; and human iPSC-based cancer immunotherapy. 

Despite the advances in the iPSC field, major challenges remain in terms of industrializing iPSC-based therapies – specifically, relating to reprogramming and directed differentiation. Reprogramming somatic cells into iPSCs to generate a master cell bank (MCB) is a highly manual and open process, requiring specialized skills and, therefore, continuous training. The expansion process from a vial of banked iPSCs to generate large numbers of iPSCs has been the focus of recent work, leading to closed automated processing that can support industrialization (1, 2). Following expansion, directed differentiation of cells to the target cell type remains highly variable, however. A prime reason for this is that directed differentiation requires very careful optimization of the differentiation factors, their concentrations, and timing of their addition – all of which vary depending on the target cell type and the protocol used by different investigators (3). Current processes for directed differentiation for the generation of iPSC-derived cell therapy products are also not robust and reproducible, and tend to rely on highly manual, open manipulation steps. Moreover, some of the critical materials used in the process may lack qualified or reliable manufacturers/vendors – and some are only available as research-use only reagents.

Read the full article now

Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE!

Login

Or register now - it’s free!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

When you click “Register” we will email you a link, which you must click to verify the email address above and activate your account. If you do not receive this email, please contact us at [email protected].

About the Author

Behnam Ahmadian Baghbaderani

Behnam Ahmadian Baghbaderani is Global Head of Process Development, Lonza Cell and Gene Therapy.

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register