Raising the bar for therapeutic T cell manufacturing with PLTGold® HPL

Expansion and modification of T cells ex vivo holds great promise in regenerative medicine for treating cancer and autoimmune diseases. Engineered Chimeric Antigen Receptor (CAR) expressing T cells have demonstrated potent clinical efficacy in patients and show profound promise for many cell therapy applications. 

Despite the great therapeutic value of T cell culture, its rather surprising to realize that much of the T cell developmental and clinical research, as well as the production of T cell therapies, is still being performed using cell culture media containing fetal bovine serum (FBS). 

While the FBS in this case is considered an “ancillary material” – meaning, a reagent that is used in manufacture and development of a therapeutic product, but is not present in the final product itself – there are major drawbacks to incorporating an undefined animal-derived component in the media. The cost, limitations in supply, batch-to-batch inconsistency (both in composition and concentrations), and the overall xenogeneic nature of FBS in the cell-therapy manufacturing workflow can be quite concerning, especially when it comes to the safety of the cell-based product.

Human Platelet Lysate

Human platelet lysate (hPL) produced from platelets has been proven to be an effective, consistent, and safe alternative to FBS in T cell culture applications.  PLTGold® hPL is a heparin-free hPL derived from human platelets to provide an entirely human-derived, rich, and effective growth supplement.  PLTGold is manufactured from FDA and AABB accredited blood banks under cGMP conditions in large pooled production batches to minimize lot-to-lot variability.

There is extensive evidence to show that PLTGold hPL outperforms FBS to culture a number of therapeutic cell types, most notably mesenchymal stem cells (MSCs) and T cells.  Additionally, PLTGold is generally supplemented at 5% or less (vol/vol) in culture medium, whereas FBS is added at 10% (vol/vol) or more, making PLTGold a cost-effective alternative producing a higher cell yield.

Figure 1:  PLTGold hPL outperforms alternative serum solutions.  PLTGold supplementation (5%) shows increased growth kinetics (reduced doubling time) and higher cell yield overall when compared to FBS (10%) and human AB serum (5%) supplementation across a number of cell types.  The above chart shows the comparative cell growth of human adipose-derived mesenchymal stem cells (MSC).

Improve safety with pathogen reduced HPL

With the emergence of new infectious diseases, potential transmission of pathogens via blood-derived products is a concern in clinical applications.  Pathogen-reduced hPL helps to further improve the safety profile of materials and media used for cell-based therapies.  PLTGold®-GI is a new hPL reagent that has been gamma-irradiated for viral inactivation and pathogen reduction using a process that maintains high hPL quality and effectiveness.

Some of the challenges of CAR-T cell production is the efficiency of transduction, the expansion of T cells to clinically relevant numbers, and the long-term survival of the therapeutic cells in vivo.  The use of hPL in T cell culture media has previously been shown to improve the transduction of primary T cells, as well as the expansion and prolonged survival of cells in vivo. PLTGold and PLTGold-GI not only enhance the performance of the T cell workflow compared to other human or animal serum-derived supplements, but also more efficiently promote higher T cell yields with lower exhaustion rates over other commercially available hPL reagents.

Figure 2:  PLTGold-GI outperforms alternative hPL supplements for T cell expansion. Comparison between PLTGold®-GI and other commercially available gamma-irradiated human platelet lysate solutions used as supplements for the expansion of T cells in vitro. 

Driving cell therapy forward

CAR-T-based cell therapies in particular will benefit from PLTGold-GI hPL in bioprocessing and manufacturing workflows to enable highly proliferative, healthy, and safe cells for therapeutic use. Today, several laboratories and hospitals around the word are using PLTGold and PLTGold-GI to expand T cells and to develop CAR-T based cancer therapies. For more information or to request a quote, please contact our customer service team for more information.

Learn More

Did you know that Captivate Bio is the LARGEST supplier of human platelet lysate for both research and cell therapy applications? Contact us today for more information.

• Research Spotlight: Expanding T cell-based therapies with human platelet lysate
• Research Spotlight: Gamma irradiated HPL enables safe and efficient cell expansion
• Download our Human Platelet Lysate for Cell Therapy Research Brochure
• Explore PLTGold Human Platelet Lysate and PLTGold-GI product information page
• Learn about more Human Platelet Lysate varieties in both research and clinical grades