Novozymes Biopharma's Recombumin and Albucult products comply with the excipient monograph standard for recombinant human albumin, published in the US Pharmacopoeia - National Formulary (USP-NF).
The monograph was first published in November 2008 and became official on 1 May 2009.
Recombumin offers the stabilising and formulation benefits of human derived albumin in a GMP compliant and regulatory friendly package.
Derived from Novozymes' yeast expression technology, it is an animal-free, commercially available recombinant human albumin for use in the manufacture of licensed and developmental human therapeutics in the US and European markets.
Albucult is also a yeast-derived recombinant albumin, targeted for use in specialised cell culture and as a bulk drug manufacturing raw material, such as in peptide or small molecule drug chemical coupling for delivery or half-life extension.
The monograph refers to recombinant human albumin as 'rAlbumin Human NF' listed as a 'sterile vehicle', meaning that it is intended for injection into humans alongside the active ingredient, and as such needs to be of the highest safety and quality.
