Cell culture media, novel resin technologies, and single-use systems are among the most active areas of R&D in the biomanufacturing sector. GEN recently interviewed several scheduled speakers for the upcoming “Bioprocess International Conference” in Long Beach, CA, to get a better sense of how this market is evolving and to see what types of new products are available.
Until the late 1980s, manufacturers of biopharmaceutical products cultured their cells in fetal bovine serum, despite lot-to-lot inconsistency, contamination, and supply issues. With the discovery of bovine spongiform encephalopathy in the late 1980s, and with resulting increases in regulations, manufacturers began to aggressively explore alternatives to serum-based media.
The upshot has been a growing interest in supplements in which all components are entirely chemically defined, animal-free, and protein-free.
In response to this demand, said Samuel Denby, Eng.D., scientific manager for technical applications at BD Biosciences, the company is now marketing BD Recharge™, a chemically defined cell culture media supplement. The product is the first in a series that BD is developing.
“We use proprietary fractionation processes combining analytical methods and bioassays to identify the key components in a yeast extract peptone,” he said. “From these we then selected the optimal chemical constituents for cell nutrition. Although our initial focus has been CHO cell lines, we have several customers evaluating other lines.”
Dr. Denby claimed the product offers equivalent or better yield as compared with traditional peptone supplementation, a reduction in variability while retaining protein quality, and the potential for an easier regulatory filing in biopharmaceutical manufacture.
Supplements need to be evaluated not only for their growth potential but also for their productivity, continued Dr. Denby.
“We typically start with small batch cultures and move up to confirm our results in small-scale bioreactors. In terms of developing our next-generation supplements, pulling the peptones apart is challenging, but putting a chemically defined alternative back together again is equally challenging.
“We use a cross disciplinary team, as well as alpha site evaluations with multiple biopharmaceutical manufacturers who tested the product with production cell lines.”