Novozymes Biopharma, part of Novozymes A/S, a provider in bioinnovation, has signed a supply agreement for albucult, a recombinant albumin with a manufacturer of medical disposables for open heart surgery to launch first Class III medical device containing albucult.
Novozymes Biopharma has supplied animal-free, recombinant human albumin to the manufacturer for over 10 years and the new agreement solidifies the prior partnership between the two companies.
Albucult, derived from Novozymes Biopharma’s yeast expression technology, delivers enhanced performance and quality benefits to medical applications including device coating, sealants, and cell therapy applications.
Class III devices are highly regulated and used in ‘high risk’ applications such as pacemakers and heart valves. The use of albucult within such medical devices offers a range of advantages including sustainability of supply, GMP compliance and improved biocompatibility. albucult also offers batch-to-batch consistency which can significantly reduce lot testing burdens for clients.
Dermot Pearson, marketing director of Novozymes Biopharma, said: “This continued partnership demonstrates Novozymes’ strength and extensive understanding of manufacturing, regulatory and global supply, making the company an ideal partner to work with. It is a great achievement for albucult to be used for the first time within a Class III medical device product and is a real testament to the quality and innovation of the products that we are developing.”