Novozymes Biopharma has built a cGMP plant in Tianjin, China, to enable Hyacare, Novozymes' form of Bacillus-based hyaluronic acid (bHA), to be used in the bio-medical and pharmaceutical industries.
The facility cost DKK300m (GBP36m) and will produce bHA products to pharmaceutical-grade Q7, paving the way for use in medical devices and pharmaceutical applications.
Novozymes Biopharma claims that by introducing large-scale GMP Q7 production in the first quarter of 2011, it will set a new benchmark for producing HA for applications from ophthalmic surgery to drug delivery.
Hyacare is a recombinant source of HA.
The Hyacare process is free from animal-derived components and is produced without organic solvents.
Novozymes Biopharma developed this animal-free HA using a non-pathogenic method, by fermenting a well-documented production strain, Bacillus subtilis.
The Bacillus strain is a well-characterised, endotoxin-free organism 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.
