Webinar Description:

GMP cell manufacturing for new clinical cell therapies is a rapidly expanding need in the life science space. This presentation will discuss the foundation of cell therapy product development considerations when preparing to launch into manufacture of materials in support of early Phase clinical trials to commercialization. Historical development of an autologous canine mesenchymal stem-cell product that facilitated the ability to rapidly respond to develop and manufacture an allogeneic human MSC product for treatment of COVID-19 patients with ARDS will be presented.

Learning Objectives:

• MSC isolation from tissue to success in primary cell culture
• Characterization of cell lines
• Avoiding development pitfalls in the scale-up of cell therapy manufacturing

Speakers:

Carolyn Wrightson, Ph.D.
Chief of Operations
VetStem Biopharma
● Personalized Stem Cells ● Performance Cell Manufacturing

Carolyn has over 25 years of experience in life science industry covering genetic discovery, protein synthesis and analysis, and cell culture.

At VetStem Biopharma she has led development of both Veterinary and Human mesenchymal stem cell manufacturing products having initiated over 2,500 primary cell cultures in 31 different species for autologous clinical therapeutic use. She has experience in GMP facility design, as well as writing CMC documentation in support multiple IND and INAD approved applications. VetStem Biopharma has branched out their skills and services beyond veterinary services recently forming two new divisions. Personalized Stem Cells (PSC) providing autologous stem cell therapy options manufactured to GMP standards, as well as Performance Cell Manufacturing.

Building upon years of experience, in 2020 PSC submitted and IND for approval, rapidly developed and manufactured an allogeneic Phase I/IIa human mesenchymal stem cell therapy product. Upon FDA approval, this product was licensed and subsequently taken into clinical trial use in the treatment of COVID-19 patients suffering from ARDS. This product recently finished Phase Ib under the product name COVI-MSC and demonstrated a 100% hospital discharge rate.

As an expert in cell therapy manufacturing, her team also provides contract product development and manufacturing services as Performance Cell Manufacturing for manufactured cells used directly or in support of cell therapy products in clinical trials. PCM assists their customers to rapidly and economically achieve GMP manufactured products by providing Phase appropriate services, regulatory compliance, technical transfer with process optimization, and scalability.

Austin Mogen, Ph.D.
Senior Field Application Scientist
Corning Incorporated | Life Sciences

Dr. Austin Mogen is a Senior Field Application Scientist at Corning Life Sciences. He received his doctorate from the University of Florida and gained industry experience as a Senior Scientist of upstream process development and manufacturing supervisor for viral vector manufacturing. In this position he focused on bioprocess development, closed system solutions for cell culture scale-up, and viral vector production. Since joining Corning Dr. Mogen works extensively with academic researchers and process development groups, optimizing cell culture assays and cellular scale-up conditions for viral production, cellular therapeutics, and biologics.

Cost: No Cost!