Bovine-derived media still 'gold standard' despite safety and reliability concerns, expert

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.”​

Problems​

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.

Stemulate​

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.