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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

View it here
 

 THE NEW SCALE FOR MEASURING HA

 

 

               

 Click to download the brochure

 

 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

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