Novozymes Biopharma develops and manufactures high-quality, animal-free, and regulatory-compliant recombinant ingredients and technologies to provide pharmaceutical and medical device manufacturers the knowledge-based solutions needed to address the challenges in developing innovative, safer, and more consistent products.
The company's large-scale manufacturing facilities worldwide are run to cGMP Q7 quality standards to ensure that customers receive the highest level of product quality and consistency, as well as the security of long-term supply. Novozymes’ customer-integrated approach combines the company’s scientific know-how and the specific needs of customers to deliver improved products and performance.
Innovation driven by experience
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 market. Currently, 14% of the company’s total revenue is spent on R&D projects demonstrating a commitment to scientific innovation.
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.
* Meets National Formulary (NF) standards as published by the United States Pharmacopeia (USP).
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
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.
Experienced regulatory support
Up-to-date and efficient regulatory support services are available to fast-track customers’ regulatory filings through:
- Experienced dealings with regulatory agencies, such as FDA, EMA, TGA, and Health Canada
- Support of animal-free recombinant products and technologies
- Preparation and maintenance of regulatory support dossiers, such as drug master files, clinical trial applications, and product dossiers
- Application of QbD principles to remove animal-derived materials from manufacturing processes
Quality assurance and consistency
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.
Towards a greener world
Novozymes believes in a future where biological solutions and processes will be instrumental in the manufacturing of many more innovative products. Combining biotechnology, experience, and creativity, Novozymes would like to explore the opportunities with you.