Lean, Mean, Productivity Machine
Biomanufacturing is growing leaner from an operational standpoint, says Bruce Lehr, director of marketing at SAFC Biosciences. The lean imperative has led to streamlining at every stage and level of manufacturing processes.
“Customers increasingly ask for applied solutions. For example, reconstituting media and buffers into concentrates, supplying them in disposable packaging, and integrating into the customer’s process to save time, labor, and cost,” says Lehr. SAFC performs significant work for customers on simplifying feeds, combining multiple feeds into one product, and providing highly concentrated feed or media solutions from standard formulations.
SAFC’s imMEDIAte ADVANTAGE™ service, for example, creates made-to-order cell culture media, buffers, concentrates, and supplements, and supplies them at smaller minimum volumes than is typical for large-scale manufacturing. Most imMEDIAte ADVANTAGE orders ship within 10 working days of receipt.
The push from 2–3 grams per liter protein titers to 5 and 10 g/L and beyond will require a confluence of high-producing cells, optimized media and feed strategies, and advanced bioreactor technologies. “All of these must work together to enable the massive titers expected over the next few years,” Lehr notes.
For now, collaborations between SAFC and bioreactor companies are limited to the disposables arena. SAFC has been working with Advanced Scientifics on prefilled bags containing concentrates, buffers, and media, for pilot-scale processes.
The trend toward animal-derived component-free (ADCF) ingredients in mammalian cell culture continues, as does usage of chemically defined media. With these advances comes greater concerns over raw material purity, where ingredients are sourced, and an interest in supply chain integrity that is usually reserved for finished pharmaceutical products.
One of SAFC’s recent service offerings is a CHO media and feed library consisting of more than 20 unique animal component-free, chemically defined formulations that cover nutrient requirements for a wide range of CHO cell lines. Customers can screen cells against each of the media and use the products as-is, or ask SAFC to optimize them for their specific cells.
Lehr does not claim that the library will optimally cover every CHO cell’s requirements for maximum growth and productivity. “Individual clones can vary quite a bit, even among those from the same parental cell, depending on what proteins are expressed,” he says.
SAFC has been marketing ADCF long R3-IGF (insulin-like growth factor), which replaces insulin as a growth factor in mammalian cell culture. Insulin manufacturers, says Lehr, typically focus on therapeutic markets, relegating insulin for cell culture as an afterthought. This product addresses the particular need for growth factors in cell culture and is produced independently of the much larger therapeutic market. Novozymes manufactures the IGF product for SAFC.