Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, 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 2012.
Novozymes develops and manufactures high-quality, animal-free and regulatory-compliant recombinant ingredients and technologies to provide pharmaceutical and medical device manufacturers with the knowledge-based solutions needed to address their challenges and develop innovative, safer and more consistent products.
With over 25 years’ experience in the pharmaceutical industry, Novozymes is the world leader in the supply of recombinant products and technologies to the medical device and drug delivery markets. Currently, 14% of Novozymes’ total revenue is spent on research and development projects with more than 6,000 granted and pending patent applications, demonstrating a commitment to scientific innovation.
Novozymes’ large-scale manufacturing facilities worldwide are run to cGMP/Q7 quality standards ensuring customers receive product quality and consistency, as well as the security of long-term supply. The company’s customer-integrated approach combines Novozymes’ scientific know-how with the specific needs of customers to deliver improved products and performance.
Novozymes offers a range of recombinant albumins (rAlbumin) developed to provide customers with a safe and consistent regulatory-compliant product. Novozymes’ rAlbumins are manufactured to large-scale in a proprietary Saccharomyces yeast strain to cGMP/Q7 quality standards, free of animal or human-derived products and supported by a strongly documented safety package and drug master file.
Novozymes’ Bacillus-derived hyaluronic acid (HA) is produced using an innovative manufacturing process that raises the current standards of purity, safety and consistency. The fermentation of the safe bacterial strain Bacillus subtilis, a well-established, nonpathogenic host whose products are generally recognised as safe (GRAS) by the FDA, is a world first. Current commercial sources of HA are derived from rooster combs or various strains of Streptococcus both of which provide a contamination risk from animal-derived material or endotoxin respectively.
Experienced regulatory support for recombinant products
Novozymes offers up-to-date and efficient regulatory support services to fast track customers’ regulatory filings through:
- Experienced dealings with regulatory agencies; e.g. FDA, EMEA, TGA, Health Canada
- Support of Novozymes’ animal-free recombinant products and technologies
- Preparation and maintenance of regulatory support dossiers; e.g. drug master files, clinical trial applications, product dossiers
- Application of QbD principles to remove animal-derived materials from manufacturing processes
Quality assurance and consistency
Novozymes’ quality-assured, consistent products and technologies are designed with an understanding of the regulatory landscape. Dedicated product support and expertise delivers a rapid response to regulatory queries facilitating the regulatory process of customers’ products and technologies.