First USP OK for rHAs a "significant advantage", says Novozymes
Novozymes’ product manager Dermot Pearson spoke with in-PharmaTechnologist about the technology behind Recombumin and albucult, the significance of compliance and the market advantage the firm gains by being the first to achieve it.
He also explained about some of the regulatory advantages that compliance will give Novozymes' customers, citing in-process development projects by US drugmaker Merck & Co and Canada's Conjuchem as examples of those that are already benefiting.
For background, the United States Pharmacopeia’s (USPs) monograph, which came into effect on Friday of last week having been issued in November, is designed to govern the safety, composition and quality of recombinant human albumins used in pharmaceutical manufacturing and excipient applications.
