Novozymes Biopharma's Recombumin and albucult products are the first to comply with the new excipient monograph standard for recombinant human albumin, published in the U.S. Pharmacopoeia - National Formulary (USP-NF). First published in November 2008, the monograph has become official. The use of these products is intended to ease the regulatory process for customers and set the industry benchmark for recombinant human albumin.
Recombumin offers the stabilizing and formulation benefits of human derived albumin and is GMP compliant. Novozymes' yeast expression technology is animal-free, and recombinant human albumin is available for use in the manufacture of licensed and developmental therapeutics in the U.S. and Europe. 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.
The monograph refers to recombinant human albumin as "rAlbumin Human NF" listed as a "sterile vehicle" intended for injection into humans together with the active ingredient, and needs to be of the highest safety and quality.
Wayne Prestwood, principal regulatory associate at Novozymes Biopharma said, "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."