Novozymes Biopharma announced the construction of a new cGMP facility at the company’s existing site in Tianjin, China that will enable its novel form of Bacillus-based Hyaluronic Acid (bHA), HyaCare, to be used within the bio-medical and pharmaceutical industries.
With a significant investment of over DKK 300 million, this new facility will produce bHA products to pharmaceutical grade Q7, paving the way for use in medical devices and pharmaceutical applications. Novozymes Biopharma are 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 is the world’s first and only recombinant source of HA. HyaCare 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 completely 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 unique non-pathogenic method by fermentation of a well documented 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. Regulators are ever more cautious with regards to the safety of products and so a cGMP compliant facility is an essential part of our strategy in bringing bHA forward for use in medical device and pharmaceutical applications,” comments Hans Ole Klingenberg, Director, 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.”
Date: April 27, 2009