Novozymes says a recombinant albumin product usually used to stabilize vaccines has been approved in Japan as part of a coating for medical devices.
Japanese regulators cleared Maquet’s Bioline coating system – which includes Novozyme’s Recombumin product – as a coating designed to protect medical devices from damage arising from prolonged exposure to circulating blood cells.
Novozymes’ spokesman Dermot Pearson told in-Pharmatechnologist.com that: “By using Recombumin Alpha as a key component, the efficacy of medical device coatings can be improved, strengthening their ability to reduce surface friction and minimize blood clotting.
He explained that in contrast to current alternatives, Recombumin Alpha is completely animal-free and regulatory compliant and suggested that this – coupled with the fact the ingredient is already known to regulators – will be an advantage for device makers.
“Novozymes’ Recombumin Alpha is manufactured to regulatory standards and delivers a secure supply of batch-to-batch consistency. This regulatory compliance and consistency reduces processing and testing times to drive product efficiency for customers.”
Pearson added that: “Novozymes supplies Maquet with its Recombumin Alpha rAlbumin and provides the company with experienced technical, product and regulatory support. It is a supplier partnership rather than a co-development partnership.”
Approval in Japan came at a busy period for Novozymes albumin business. In mid-February , EpiVax selected Novozymes Albufuse platform to extend the half-life of its new range of its candidate autoimmune disease treatments, suggesting that the tech could be the key to a $3bn market.
At the time EpiVax CEO Annie De Goot told us that Novozymes’ delivery vehicle provides a safe and effective was of delivering her firms’ range of Tregitopes, which are based on IgG peptides designed to stop the immune system from overreacting to stimulation by ‘self’ peptides.
More recently, GSK filed its candidate diabetes treatment Eperzan for European regulatory review setting Novozymes up for another potential payday.
GSK uses Novozymes’ albufuse technology to increase the drug’s circulatory half-life and – if it goes on to be approved – will pay the Danish firm royalties according to a report by Bloomberg earlier this week.