Novozymes Biopharma is the result of a number of acquisitions in the last few years, including Delta Biotechnology Ltd in the UK and GroPep in Australia. The synergies between the various activities in Novozymes Biopharma and also with Enzyme Business are now beginning to show in terms of an attractive product portfolio of animal-free ingredients for cell culture media and other areas in biopharmaceutical production.
Just like enzyme products, the pharmaceutical ingredients sold by Novozymes Biopharma are made by microorganisms. The advantage of microbially produced ingredients is that they come from an identified, controlled, nonanimal, and nonhuman source and can be made consistently to recognized quality standards. The disadvantage of using raw materials from an animal or a human source is that they must be assessed for the presence of viral or other potentially pathogenic organisms.
One example is human serum albumin (HSA), naturally produced by the liver and found in blood plasma. It is extracted from human or animal blood and has played an important role in the development of a wide range of biopharmaceutical products and as a nutrient in cell culture media. However, with concerns about animal-derived materials, the regulatory authorities are now strongly recommending that drug and device manufacturers seek alternatives to all components of animal origin.
Recombumin® from Novozymes is the world’s first and only animal-free recombinant HSA on the market approved for use in the manufacture of human therapeutics. Recombumin is produced by the yeast microorganism Saccharomyces cerevisiae (baker’s yeast). It is structurally identical and comparable in safety and tolerability to human serum albumin (HSA). The first commercial approval for the use of Recombumin was in 2005 for the manufacture of the childhood vaccine M-M-R® II by Merck & Co.
Another development of interest to pharmaceutical companies is albumin fusion technology that can considerably extend the half-life of drugs by fusing albumin and the active pharmaceutical ingredient together, leading to fewer side effects, better tolerance, and less frequent injections. This technology is being licensed out by Novozymes Biopharma to pharmaceutical companies, and a number of drugs manufactured using this technology are presently undergoing late-phase clinical trials.
Apart from biopharmaceutical ingredients and technology, Novozymes Biopharma also offers customized pharmaceutical-grade contract manufacturing services at its production facilities in Lund, Sweden.