Fetal bovine serum (FBS) is used by CAR-T cell and biologic makers as a culture supplement due to it having a content of embryonic growth promoting factors and a low level of antibodies.
The serum is “the gold standard for cell culture supplements,” Henk Snyman, Director of Medical Affairs at Cook Regentec, told delegates at the Cell Therapy Manufacturing & Gene Therapy Congress in Brussels this week.
“FBS will be around for some time, with hundreds of thousands of litres being used each year,” he continued, as “when it works it works very well.”
However, FBS is – as a by-product of the Dairy industry – animal-derived which has led to concerns about the potential for transmitted bovine diseases, he continued.
Furthermore, “for a product which has been around in the industry for some years it is very poorly characterised.”
He added the product also poses a problem due to its inconsistency in supply, pricing and batch-to-batch variability.
Cook Regentec is a bioprocessing services company spunout of medical device maker Cook Medical, and offers cryopreservation solutions and its own cellular growth media offering, Stemulate.
Stemulate is a pooled Human Platelet Lysate (HPL) culture media supplement and according to Snyman is “essentially equivalent in biology and efficacy” to FBS, and though it is currently unstandardized, he said the firm “is making good progress.”
The clinical grade Stemulate is produced according to GMP conditions using human donor platelets obtained from accredited blood centers, and 115 pooled donors makes around a 20 litre batch.
The product is one of several non-animal derived supplements available for cell therapy makers. Last year, Irvine Scientific launched Prime-XV for the expansion of human T Cells.
At the time, Chief Scientific Officer Jessie Ni told us there has been “significant progression around T cell research” but the cell culture and media development “has not progressed too quickly” over the past 30 years.