USP-NF compliant recombinant human albumins

Novozymes Biopharma has announced that its Recombumin and albucult products comply with the new excipient monograph standard for recombinant human albumin, published in the United States Pharmacopoeia — National Formulary (USP-NF). The monograph was first published in November 2008 and became official on 1 May 2009. As these products comply with the monograph, their use eases the regulatory process for users and sets the industry benchmark for recombinant human albumin.

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. The monograph is available to USP-NF subscribers and can be accessed at http://www.uspnf.com/uspnf/login.