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Novozymes Biopharma Builds cGMP bHA Facility

Novozymes Biopharma has begun construction of a new cGMP facility at its existing site in Tianjin, China, enabling the company to produce Bacillus-based Hyaluronic Acid (bHA), HyaCare, for the bio-medical and pharmaceutical industries.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Novozymes Biopharma has begun construction of a new cGMP facility at its existing site in Tianjin, China, enabling the company to produce Bacillus-based Hyaluronic Acid (bHA), HyaCare, for the bio-medical and pharmaceutical industries. HyaCare is the first recombinant source of HA. The HyaCare process is free of animal-derived components and produced without the use of organic solvents.

The company will invest more than $53 million in this new facility, which will produce bHA products to pharmaceutical grade Q7. Novozymes Biopharma is planning for the production of HA for applications from ophthalmic surgery to drug delivery, with the launch of large-scale GMP Q7 production planned for 1Q11.

“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,” said 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.”

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