The study investigated the ability of Recombumin, a recombinant human albumin expressed in Saccharomyces cerevisiae, to prevent the deterioration of protein drug products in a variety of test formulations. It particularly addressed Recombumin’s minimisation of surface adsorption, oxidation and aggregation compared with excipients commonly used for the purpose of formulating protein drugs.
The results demonstrated that Recombumin has the capacity to improve the shelf life of protein drug products. They also indicated that Recombumin performed as well as and often better than comparative products making it an effective multi-purpose excipient with the capability to reduce the total number of excipients required and therefore simplifying the formulation strategy.
Derived from Novozymes Biopharma’s proprietary yeast expression technology, Recombumin is a leading animal-free, commercially available recombinant human albumin used in the manufacture of licensed and developmental human therapeutics.
Offering the stabilising benefits of albumin in a GMP compliant and regulatory package, Novozymes says Recombumin ensures high performance and security of long-term supply. Its compliance with the excipient monograph for recombinant human albumin published in the United States Pharmacopoeia – National Formulary (USP-NF) also eases the regulatory process for customers.