Novozymes Sets Gold Standard as Supplier of World's First USP-NF Compliant Recombinant Human Albumins
News May 04, 2009
Novozymes Biopharma, part of Novozymes, has announced that its Recombumin and albucult products are the first to 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 1st May 2009. As these products comply with the monograph, their use eases the regulatory process for customers and sets the industry benchmark for recombinant human albumin.
Recombumin offers the stabilizing and formulation benefits of human derived albumin in a GMP compliant and regulatory friendly package. Derived from Novozymes' proprietary yeast expression technology, it is 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 specialized 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.
Wayne Prestwood, Principal Regulatory Associate at Novozymes Biopharma comments, "We are delighted to be setting the gold standard with our Recombumin and albucult products by being the first to comply with the new monograph. This is of significant benefit to our customers, providing peace of mind whilst facilitating regulatory agency review and approval."
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.