New Novozymes unit backs animal-free protein production
to make and sell ingredients that support companies wanting to
produce biopharmaceuticals without using animal-derived
constituents.
Peter Rosholm, who took over as vice president for Novozymes' ingredients business earlier this year, said the unit had been set up to handle three new products aimed at improving the production of biopharmaceuticals in animal-free cell media. There has been a shift away from using ingredients sourced from animals, such as serum, in biologics production in recent years mainly because of the concern that they might contain infectious agents such as viruses, mycoplasma or transmissible spongiform encephalopathies (TSEs). "Cell culture media based on serum is great, because it has all the ingredients needed for cells to grow well, but biologics manufacturers have started to shun it for safety and other issues," said Rosholm in an interview. However, those who make the shift to reduced-serum or serum-free products often have to cope with a trade-off in reduced yields. Novozymes hopes to tip the balance in their favour by launching growth factors and other ingredients that help the cells grow well in culture and improve the yield of their biologic payload. Novozymes already has some products used in cell-based biopharma production, but the spur for setting up the new unit comes from recent and upcoming launches. The new products come from a combination of in-house research and recent acquisitions, notably of Delta Biotechnology and GroPep in July 2006 and December 2006, respectively. New products Novozymes has been working for some time to develop a recombinant form of the ubiquitous serum protein albumin, which helps protect fragile molecules in culture and also plays a key role in maintaining the health of cells. Recombumin is billed as a direct replacement for human serum albumin in protein drug formulation. The GroPep acquisition added LR3 (or Long-R3-IGF), the only recombinant insulin-like growth factor-1 (IGF-1) on the market for use in cell culture. This product accounted for the bulk of GroPep's sales and is already used in the production of a number of biopharmaceutical products. Finally, Delta has contributed DeltaFerrin, a transferrin molecule that supports cell growth in culture and has efficiency advantages over other growth factors such as insulin. Regulators have stopped short of banning animal products in biopharmaceutical manufacturing, and the reality is that some biologic drugs simply cannot be made without it. But when producers - and particularly risk-averse big pharma companies - have made the shift to an animal-free process, use of these ingredients can provide not only increases in productivity but also benefits in compliance with regulatory requirements and improved consistency in the process. Compliance is helped by removing the animal constituents that demand more rigorous quality control measures such as assaying to ensure there is no contamination. Consistency is improved by doing away with the batch-to-batch variability that can affect supplies of animal-derived ingredients. "The design and manufacture of recombinant ingredients for the biopharmaceutical industry represents a natural and significant development in terms of Novozymes' traditional business," said Rosholm. "We have combined Novozymes expertise in large scale protein production and supply with a strong science base to provide a range of products specifically developed for biopharmaceutical production." Rosholm would not be drawn on the size of the new unit in terms of revenues, saying that more information would be given when the company reports its quarterly results next week.
