Improve the safety and stability of your drug product
By harnessing Novozymes' recombinant, animal-free products and technologies, and with our guaranteed promise of consistency and long-term supply, we can streamline your drug or device development process, allowing you to commercialize your product faster, while maintaining safety and compliance.
Our solutions offer
- Efficient drug development
- Regulatory-compliance, safety, and consistency
- Security of long-term supply from Q7 cGMP, large scale facilities
Hyaluronic acid - Hyasis®
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. In an effort to overcome this shortcoming, Novozymes has built an entirely new, dedicated HA plant in Tianjin, China, to manufacture hyaluronic acid to Q7 cGMP standards. Bacillus
-derived hyaluronic acid is produced using an innovative manufacturing process that raises the current standards of safety, consistency, and performance. The innovative technology is based on fermentation of the safe bacterial strain Bacillus subtilis
, a well-established, nonpathogenic host which has been used by Novozymes to produce a series of products which have been granted GRAS (Generally Recognized As Safe) status in the US. To achieve a high degree of purity, the process uses minimal media, no animal-derived raw materials, and a proprietary water-based technology that eliminates the use of organic solvents. Learn more at www.hyasis.com
Recombinant albumin USP-NF* – Albucult®, Recombumin®
A range of high-quality, animal-free, 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. Suitable for a range of applications such as the formulation of pharmaceutical drugs, vaccines, and medical device manufacturing.
Albumin fusion technology – Albufuse®, Albufuse®Flex
A natural alternative to PEGylation, Albufuse is a proprietary albumin fusion technology that allows the molecular fusion of albumin-to-protein drug candidates for improved half-life and bioavailability. The technology can reduce dose frequency requirements and side effects. Combine albumin fusion technology with Novozymes’ yeast expression technologies and cCMP/Q7 manufacturing services to maximize the benefits of working with them. AlbufuseFlex allows greater ability to tailor, adapt, and control the pharmacokinetics (PK) of the target protein or peptide while retaining drug efficacy. Through subtle modification of the albumin molecule, this innovative technology aims to improve the circulatory half-life of the albumin molecule itself, thereby conferring these advantageous properties to any fused protein or peptide.
* Meets National Formulary (NF) standards as published by the United States Pharmacopeia (USP).