Novozymes Biopharma reports that one of its major customers has achieved approval of a medical device in Japan using Recombumin Alpha – formerly Albucult, a recombinant human albumin (rAlbumin) product.
MAQUET Cardiopulmonary is using Recombumin Alpha in a version of the company’s proprietary Bioline coating, which has already received regulatory approval and is being used in many countries worldwide.
This approval is the first for a medical device product in Japan.
The use of Recombumin Alpha in MAQUET’s Bioline coating confers a number of advantages due to its stable, pure and safe composition – it enables manufacturers to streamline their regulatory approval processes and accelerate a product’s time-to-market.
Novozymes’ rAlbumins have been assisting MAQUET in developing safe, regulatory compliant products for more than 10 years as part of an ongoing strategic partnership between the two companies.
The Bioline coating has been developed to improve the biocompatibility of extracorporeal circulation system devices, such as oxygenators, which come into contact with blood during heart surgery. Whether for oxygenators, centrifugal pumps, filters, reservoirs, venous bubble traps, catheters and cannulae, tubes or tubing set accessories, a consistent quality of Bioline coating is supplied for all applications.
The use of Recombumin Alpha in the Bioline coating approved for the Japanese market helps to improve the biocompatibility of these devices, while its safety and purity profile minimises the risk of contamination and impurities.
Wolfgang Rencken, President and CEO of MAQUET Cardiopulmonary said: ‘With Novozymes’ rAlbumin, MAQUET is now able to offer our highly biocompatible BIOLINE Coating in Japan. Reducing negative side effects on blood when it comes into contact with foreign surfaces, such as polycarbonates or tubings, has always been one of MAQUET’s focus areas in extracorporeal circulation. We are very happy to offer this advantage to our customers and especially their patients in Japan.’