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ISCT Webinar 2019: Critical Ancillary Materials for Cell & Gene Therapies

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Critical Ancillary Materials for Cell & Gene Therapies: 
Addressing the Impact of Human Serum and Serum Alternatives

Sponsored by Akron Biotech and Cook Regentec

An ISCT Process and Product Development Subcommittee Webinar

Event Date
Wednesday, October 30, 2019
08:00 PDT, 11:00 EDT


About the Webinar
Ancillary materials are critical to the long-term success of your cell and gene therapy product. Critical considerations for ancillary materials of biological origin include sourcing, manufacturing, safety and performance consistency. In this webinar, we will discuss AB serum as a cell media supplement, the challenges and risks associated with its use, and potential alternatives on the horizon including TLiven , a human platelet lysate (hPL) derived product. Current standards in ancillary materials and the evolving global regulatory landscape will also be discussed.

John Fink, MBA

Senior Product Manager
Pall Corporation
Co-Chair, ISCT Process and Product Development Subcommittee
United States

Claudia Zylberberg, PhD

Akron Biotech
United States

AB Serum and Cell Therapy Development: Benefits, Challenges, and the Path Forward

Male AB Serum has long been used as a cell media supplement because it contains a mixture of proteins, lipids, and growth factors that are essential for cell culture. Additionally, Male AB serum lacks antibodies to blood type A and B antigens, has low concentrations of estrogen and Human chorionic gonadotropin (HCG) hormone, and lacks antibodies to major histocompatibility antigens; all of which can interfere with the culture of human cell lines associated with the human immune system. Because it is serum, it contains no detectable fibrinogen or any other coagulation factors that are otherwise present in whole blood and plasma. This reduces or eliminates the possibility of fibrin strand generation during downstream processing. Although Male AB Serum is a critical cell media supplement, it introduces serious quality- and supply chain-related challenges for advanced therapy developers. Variability in the donor base introduces batch-to-batch variability in the serum, the potential for contamination introduces risk into the cell therapy manufacturing process, and given the limited number of AB blood donors, there are serious challenges securing supply. This talk will focus on the benefits of AB Serum in culture, present many of the innovations that Akron Biotech has introduced to mitigate against these challenges, provide an overview of important regulatory aspects, and discuss future opportunities to improve or replace the material.

Steve Charlebois, PhD

Vice President of Engineering and Regenerative Medicine
MED Institute
United States

Pathogen-reduced human platelet lysate: a robust alternative to AB Serum in CAR T Cell Manufacturing

Advanced cell and gene therapies offer hope of treating numerous diseases previously designated incurable. No greater example is the promise of immunotherapy products such as CAR T for the treatment of hematological and solid tumor cancers. Thus far, two commercial CAR T products have gained market approval for the treatment of patients with relapsed or refractory B-Cell Acute Lymphoblastic Leukemia. However, in both cases manufacturing has proved challenging and the next wave of immunotherapies must resolve these challenges to evolve the field.

Mitigating risks associated with raw material supply chain currently represents one of the major challenges within the manufacturing of cell and gene therapies. Male AB serum is commonly used for expansion of the CAR T product. However, AB negative donors represent a small fraction of the population and, with increasing demand from the expanding field of cell and gene therapies, shortages and increasing prices are likely. It is therefore imperative to find alternative sources of cell culture supplements capable of expanding CAR T cells to the required numbers with associated efficacy.

Human Platelet Lysates (hPL) have previously been used for the clinical expansion of cells such as MSCs. However, until now, their use for expansion of CAR T cells has not been vigorously tested. TLiven, a pooled, pathogen reduced hPL produced at commercial scale, was evaluated for its ability to expand and support CAR T cell function.

The maintenance of less differentiated T cell phenotype in CAR T cells has been extensively explored by many groups using various methods (sorting or drug treatment). Here it is demonstrated that simple replacement of traditional FBS or human AB serum with TLiven can achieve same goal with potent anti-tumor effect in both in vitro and in vivo experiments.

Jiwen Zhang, PhD
VP Regulatory Affairs
United States

Regulatory perspectives of ancillary materials (AM) used in CGT manufacturing

Cell and gene therapy (CGT) products promise tremendous clinical benefits for patients who often have exhausted treatment options. However, consistent CGT manufacturing has proved rather challenging. Ancillary materials (AM) used in the CGT manufacturing is a significant contributing factor that impacts on the manufacturing success. When using AM of biological origin, safety and performance of AM are critical. Considerations should include source of the materials, manufacturing process, and testing for safety and performance consistency. When AM are human sourced, donor screening and testing need to meet regulatory requirements. This talk will discuss regulatory perspectives of CGT AM products, current standard development and future considerations, and evolving global regulatory landscape in AM requirements.


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