Novozymes Biopharma, part of Danish bioinnovation company Novozymes, is to build a DKK300m (Euro 40m) cGMP facility at its site in Tianjin, China to produce the company's Bacillus-based hyaluronic acid (bHA), HyaCare, to pharmaceutical grade Q7, paving the way for its use in medical devices and pharmaceutical applications.
Novozymes Biopharma is setting a new benchmark for the production of HA for applications from ophthalmic surgery to drug delivery, with the launch of large-scale GMP Q7 production planned for Q1, 2011.
HyaCare, the only recombinant source of HA, is produced using Novozymes Biopharma's patented, safe fermentation and purification technology, which results in a highly consistent and pure product. The HyaCare process is free of animal-derived components and produced without the use of organic solvents.
HA is traditionally derived from rooster combs or from strains of streptococcal bacteria, which may potentially result in safety risks from animal proteins, viruses or endotoxins. Novozymes Biopharma developed this animal-free HA using a non-pathogenic method by fermentation of production strain, Bacillus subtilis. The Bacillus strain is a well-characterised, endotoxin-free organism that is generally regarded as safe by the US Food and Drug Administration (FDA). Bacillus HA is identical to natural HA and will be backed by a safety package to support API applications.
"The strategic decision to build this new facility was based on a thorough market review and the increasing demand for bHA," said Hans Ole Klingenberg, director of Novozymes Biopharma. "China was an obvious choice as we already have a world-class manufacturing operation there with more than 20 years" experience. This site will also facilitate expansion as business opportunities develop."
