New Study Data in Protein Drug Formulation

Novozymes Biopharma announced new data which demonstrates extended shelf life of protein drug products using Recombumin®, recombinant human albumin. The data reveals the potential for Recombumin to reduce product loss by preventing the physical and chemical degradation of protein drugs.

A data sheet entitled ‘Recombumin®: A pharmaceutical excipient in the stabilisation of therapeutic protein products’ details the findings. 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. The study particularly addressed Recombumin’s minimisation of surface adsorption, oxidation and aggregation in comparison to excipients commonly used for the purpose of formulating protein drugs.

The new data demonstrates that Recombumin has the capacity to improve the shelf life of protein drug products. The study’s findings indicate that Recombumin performed as well as and often better than the comparators 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 the world’s 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, 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 and sets the industry benchmark for recombinant human albumin.