PRODUCTS

Hyaluronic acid - Hyasis®

Bacillus-derived hyaluronic acid (HA) for the manufacture of medical device and pharmaceutical products. Safety, consistency, and performance all in one raw material.

Current commercial sources of HA are derived from either rooster combs or various attenuated strains of Streptococcus and can be associated with a number of potential challenges. Owing to the risk of animal-derived contamination of the final product, the use of HA produced by rooster comb extraction is decreasing in the industry, and Streptococcus-based production has become more prevalent. However, as this organism is inherently pathogenic to human beings, there is a risk of contamination from endo- and exotoxins and other immunogenic contaminants. Both production methods also employ large volumes of organic solvent to precipitate and recover HA at different stages of the process. If not done carefully, this can lead to impurities in the final HA product.

Setting new standards for hyaluronic acid

Novozymes has built the developed Hyasis, the next generation of high-quality hyaluronic acid offering unprecedented safety, consistency, and performance to Q7 cGMP standards.

Working with raw materials that are already Q7 compliant can help medical device and pharmaceutical product manufacturers reduce testing time, save on manufacturing costs and take products to market faster. Hyasis is setting new standards for the use of HA in medical devices and pharmaceutical applications.

Key benefits - Bacillus-derived HA

Faster dissolving time reduces processing time

Up to 5 x faster dissolving time at production scale
Proven to reduce production time by up to 30-50%

Higher molecular weight retention upon autoclaving ensures a more consistent final product

Ability to withstand autoclaving in solution
Improved viscosity and up to 37% higher molecular weight retention

Safety and purity for reduced risk of contamination

No animal-derived materials or organic solvents
Very low levels of endotoxins and proteins

Consistency delivered each time, every time

Targeted molecular weights with narrow polydispersity
High batch-to-batch consistency in production at large-scale

Unique and customized solutions for desired viscosity

Dedicated R&D support team with significant HA expertise
Proprietary crosslinking technology helps achieve desired viscosity

cGMP, Q7 validated process at large-scale

Security of supply from a sustainable company
Supply from a Q7 validated facility.

Application areas - Bacillus-derived HA

CONTACT US

Hans Ole Klingenberg, Marketing Director

Rethinking hyaluronic acid manufacturing for the medical device industry

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THE NEW SCALE FOR MEASURING HA

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INNOVATION AWARD WINNER

Novozymes won the 2008 'CPhI Innovation Award' for hyaluronic acid at the CPhI worldwide exhibition in Frankfurt, Germany…see news articles about this award:

› Manufacturing chemist
› in-PharmaTechnologist.com