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Transferring cell therapies to the clinic requires large-scale and cost-effective manufacturing platforms in order for functional cells to be effectively produced at the scale required to meet clinical demand. For mesenchymal stem cell (MSC) and T cell therapies in particular, the incorporation of human platelet lysate (hPL) in the culture media is key to the efficient cGMP expansion of cells ex vivo.
PLTMax® and PLTGold® human platelet lysate (hPL) solutions offer many advantages over FBS, human AB serum, and lab-based platelet lysate production. PLTMax and PLTGold are xeno-free supplements with minimal lot-to-lot variation, generating reproducible results over time. PLTMax and PLTGold consistently outperform FBS and human AB serum by delivering cultures with higher overall cell yields, faster growth kinetics, and better cell quality.
With the continued development of cell-based therapies, PLTMax and PLTGold hPL meet the need for a cGMP, clinical grade culture supplement that is consistent, reliable, and cost-effective for large culture scale-up applications – and now, they are even safer than before.
Human platelet lysate is manufactured from platelets originally intended for clinical transfusion purposes, and are obtained through accredited blood banks in the United States. Because the platelets were already approved for patient injection, the safety of the material is managed by the US Food & Drug Administration (FDA) and the Association for the Advancement of Blood & Biotherapies (AABB), which set the safety standards for such transfusion products. By using these platelets as the raw material, PLTMax and PLTGold Human Platelet Lysate are safe, low-risk serum-replacement suitable for clinical translation.
Even so, with the emergence of COVID-19 and other infectious diseases, transmission of pathogens via blood related products is a valid concern, and the utmost safety of culture reagents used in translational research and therapeutic development is critical. For this reason, gamma-irradiated hPL, including PLTMax®-GI and PLTGold®-GI, offer added safety over potential pathogen transmission.
A pathogen-free and standardized cell culture supplement is required for the ex vivo propagation of human cells for clinical translation. Gamma irradiation of hPL is a sustainable and reliable process to obtain pathogen-reduced clinical-grade hPL. PLTMax-GI and PLTGold-GI hPL supplements have been treated with gamma irradiation for pathogen reduction in a process that maintains unprecedented levels of product quality and efficiency.
A viral clearance study performed on PLTMax-GI and PLTGold-GI showed a pathogen reduction that was equivalent or better than other commercially available gamma irradiated hPLs.
Figure 1: Viral clearance study results. PLTMax-GI and PLTGold-GI viral clearance data compared to published competitor data for gamma irradiated products. Values listed are Log10 reduction factors. The higher the reduction factor indicated, the more viral inactivation is detected. (EMCV: Encephalomyocarditis Virus; Reo-3: Mouse reovirus type 3; HSV1: Herpes simplex virus type 1)
When biological products are gamma-irradiated, some decrease in protein activity is expected, which, in the case of hPL culture supplement, can in turn affect the quality and performance of the product. After careful evaluation of multiple lots of pathogen-reduced PLTMax-GI and PLTGold-GI, only slight differences were seen in human adipose-derived MSC culture yield when gamma irradiated hPL products were supplemented compared to non-irradiated versions. Importantly, however, gamma irradiation only contributed to a 6 – 16% reduction in product potency in PLTMax-GI and PLTGold-GI supplements, as compared to a 20% reduction in potency and performance that was observed with other commercially available gamma irradiated hPL products.
For both PLTMax-GI and PLTGold-GI, even after gamma irradiation, both hPL supplements still outperformed even the non-irradiated versions of the competing products. PLTMax-GI and PLTGold-GI both show faster average doubling times, yielding higher cell yield in a shorter period of time than other non-irradiated or irradiated hPL products.
Figure 2: Cell yield for adipose-derived MSCs expanded in culture medium supplemented with non-irradiated and gamma irradiated human platelet lysates. The differences in ultimate cell yield with different hPL supplements after a 10 million cell starting population over a 7-day growth period. Cell yields were calculated using internal data and published competitor cell doubling times.
Human platelet lysate (hPL) is a superior alternative to FBS in cell culture systems, and offers many important benefits of consistency and safety to therapeutic cell culture and clinical applications. Large production batches and consistent supply of hPL manufactured under cGMP conditions further reduce lot-to-lot variability and improve bioprocessing and manufacturing reproducibility. PLTMax-GI and PLTGold-GI gamma irradiated hPL supplements provide an added level of safety as a pathogen reduced reagent, with very minimal impact on culture quality – consistently outperforming the standard versions of other commercially available hPL supplements. The faster doubling times observed with therapeutic cells cultured with PLTMax-GI or PLTGold-GI produce higher cell yields in shorter timeframes, offering a more cost-effective and efficient culture scale-up process.
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.
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Human platelet lysate has become a gold standard supplement for cell production in cell therapy research. With the largest portfolio of HPL, request a sample from Captivate Bio today.
