Novozymes bacillus sodium hyaluronate optimises safety and delivery of drug formulations
Novozymes Biopharma highlighted its innovative sodium hyaluronate and recombinant human albumin products, which offer a range of unique advantages for medical devices, drug delivery and formulation.
Novozymes’ novel sodium hyaluronate is 100% free of animal-derived raw materials and organic solvent remnants and offers a range of benefits, including increased safety, batch-to-batch consistency and stability in large scale. It is said to be the world’s first and only recombinant source of sodium hyaluronate.
Animal-free ingredients offer an ethical and safe solution for the production of ingredients that form the basis of biological products. Popularity of these ingredients is increasing as regulatory authorities begin to enforce strict quality measures on products to improve safety, particularly with potential contamination risks from pathogens such as viruses in animal-derived ingredients.
Novozymes Biopharma’s sodium hyaluronate products are fermented using a unique well-characterized, non-pathogenic, well documented and endotoxin-free production strain, Bacillus subtilis which is generally regarded as safe (GRAS) by the US Food and Drug Administration (FDA). Bacillus sodium hyaluronate is identical to natural sodium hyaluronate and is backed by a safety package to support active pharmaceutical ingredients (API) applications.
The product can be used within the pharmaceutical sector for improved drug delivery as well as in medical device application areas including ophthalmology, wound healing and dermal fillers.
The new plant will be up and running early next year
Meanwhile 2-year construction of the company’s new cGMP facility at its existing site in Tianjin, China, is proceeding on time and on budget. It is expected to begin production of Bacillus-based hyaluronic acid for use in medical devices immediately, with manufacturing for the pharmaceutical market due to commence in September.
Derived from Novozymes’ proprietary yeast expression technology, Recombumin is the world's leading animal-free, commercially available recombinant human albumin. Offering the stabilising benefits of albumin in a GMP-compliant and regulatory package for medical devices, drug delivery and formulation, Recombumin ensures high performance and security of long term supply, the company says.
According to Peter Roshholm, vice president Novozymes Biopharma, ‘these proven solutions ensure improved consistency and a decreased regulatory burden while enabling the development of superior final products.’