Novozymes' Recombinant Human Albumins Comply with New USP-NF Monograph

A new excipient monograph standard for recombinant human albumin (HSA) became official in the United States Pharmacopeia–National Formulary (USP–NF) today, and Novozymes Biopharma (Nottingham, UK) says that its “Recombumin” and “Albucult” products are the first to comply with the new standard.

The availability of a USP–NF monograph and its accompanying reference standard facilitates biopharmaceutical manufacturers’ quality control of incoming raw materials because they can test supplies according to the specifications and tests outlined in the monograph and compare them to a USP-supplied reference standard. Without the standards, manufacturers must develop their own tests, and the internal standards to which they compare the incoming supplies are subject to drift over time.

“Many of our customers have asked us if our products complied with a monograph standard, but until now there was only a monograph for plasma-derived HSA,” said Dermot Pearson, PhD, senior product director for Novozymes. “Now that there is a standard for recombinant HSA, we are proud to meet it. It demonstrates our commitment to quality and to serving our customers.”

HSA is used in some biopharmaceutical formulations as a stabilizer, and in other cases to extend drug half-life. The new monograph for recombinant HSA was first published in November 2008 and became official on May 1, 2009.