Sets new standards of safety, consistency and performance for hyaluronic acid
Novozymes Biopharma has supplied the first batches of its Bacillus-derived hyaluronic acid from its newly inaugurated DKK 350m (€47m; US$61m) manufacturing facility in Tianjin, China.
The first commercial products using Hyasis as a raw material should reach the market in Q2.
Thomas Videbæk, executive vice president of Novozymes A/S, in Denmark, said the delivery ‘marks an important milestone on our journey to becoming a leading producer of high quality hyaluronic acid.’
‘With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA, which is fully compliant with the highest pharmaceutical standards and developed with customers’ specific needs in mind,’ he said.
Videbæk says the market for pharmaceutical use of hyaluronic acid is estimated to be worth DKK1bn.
Novozymes says Hyasis hyaluronic acid offers a number of advantages over competitive sources, including superior heat stability, which permits autoclaving without significant loss of product viscosity, and tight control of molecular weight during production, which allows for excellent control in formulations.
Hyasis also offers ‘unmatched batch-to-batch consistency in production at large-scale’, and the product’s ability to dissolve five times faster than other sources can reduce processing times by up to 50%.
‘We believe we have a very strong offering for the medical device and pharmaceutical markets. Not only is Hyasis manufactured in accordance with requirements for an active pharmaceutical ingredient, it also offers unrivalled safety, consistency and performance to the benefit of our customers and partners,’ added Videbæk.
The Tianjin facility employs a patented water-based process to manufacture Hyasis to Q7 cGMP standards. Working with raw materials that are already Q7 compliant can help medical device and pharmaceutical drug manufacturers to reduce testing time, minimise documentation requirements, save on manufacturing costs and take products to market faster, the firm said.