Novozymes Biopharma has announced the first shipment of the company’s Bacillus-derived hyaluronic acid, Hyasis®, from its newly inaugurated manufacturing facility in China, which represents an investment of more than DKK 350 million.
The first commercial products using Hyasis as a raw material are expected to reach the market in Q2 of this year.
“Shipment of the first commercial hyaluronic acid material from our new Q7 GMP facility 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”, says Thomas Videbæk, Executive Vice President of Novozymes A/S.
Hyasis has been specifically designed to fill a gap in the market for biomedical and pharmaceutical manufacturers looking for Q7 regulatory compliant ingredients with superior performance benefits.
“Improving how our customers can process and formulate HA for medical applications has been the key driver in the development of Novozymes’ new patented HA production process and facility”, comments Hans Ole Klingenberg, Global Marketing Director at Novozymes.
Klingenberg continued, “Our unique technology will expand opportunities in the pharmaceutical and biomedical industries across multiple applications for HA, creating improved therapeutic treatments with real benefits for both manufacturers and patients.”
Novozymes’ focus on improving processes for its customers has resulted in a hyaluronic acid that offers a wealth of innovative advantages over competitive sources.
Superior heat stability permits autoclaving without significant loss of product viscosity, and tight control of molecular weight during production allows for excellent control in formulations.
Novozymes’ Hyasis also offers its customers unmatched batch-to-batch consistency in production at large-scale, and the capability of the product 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. In addition, customers will have access to our dedicated team of researchers who can help them solve their formulation problems, resulting in time and cost savings, manufacturing processes improvement and safer and more efficient treatments for patients. In this way, we are setting a whole new standard in the market and redefining the use of hyaluronic acid”, says Thomas Videbæk.
A critical component in the development of an improved biomedical grade HA has been the construction of the new manufacturing facility designed exclusively for Hyasis.
Located in Tianjin, China, the 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, minimize documentation requirements, save on manufacturing costs and take products to market faster.
First customers have been testing the product for some time with good results and Hyasis is now being sold to medical device and pharmaceutical customers.
Thomas Videbæk says, “The market for pharmaceutical use of hyaluronic acid is estimated to have a size of DKK 1 billion. With regulations in the medical industry getting tougher and tougher, we believe we are well positioned in Novozymes to offer customers an improved source of hyaluronic acid that will comply with their long term needs - and with our long term investment in this new facility we aim to play a leading role in the market for hyaluronic acid for many years to come.”