Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has announced that one of its leading customers has achieved approval of a medical device in Japan using Recombumin® Alpha – formerly Albucult®, a recombinant human albumin (rAlbumin) product.
Recombumin Alpha is used by MAQUET in a version of the company’s proprietary BIOLINE Coating, which has already received regulatory approval and is being used successfully in many countries around the world. This approval represents yet another landmark registration for Novozymes Biopharma’s Recombumin portfolio and the first for a medical device product in Japan. The use of Recombumin Alpha in MAQUET’s BIOLINE Coating confers a range of unique advantages due to its stable, pure and safe composition, meaning that it can enable 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 over 10 years as part of an ongoing strategic partnership between the two companies. The BIOLINE Coating has been developed by MAQUET 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 contained in the version of BIOLINE Coating approved for the Japanese market helps to improve the biocompatibility of these devices, while its unmatched safety and purity profile minimizes the risk of contamination and impurities.
Dr. Wolgang Rencken, President and CEO at MAQUET Cardiopulmonary AG comments: “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. ”
Dermot Pearson, Marketing Director at Novozymes Biopharma comments, “We are delighted that Recombumin Alpha is a component of a medical device product now approved for the Japanese market. As a business, Novozymes is conscious of the rapidly changing regulatory landscape with regulations becoming increasingly tighter. As a result, we are committed to assisting our partners in developing safe, stable and highly pure products using ingredients which are Q7 compliant.” Dermot continues, “Our long-term relationship as a strategic partner to MAQUET has worked through mutual understanding of the company’s goals and Novozymes’ deep knowledge of the regulatory processes involved in taking product to market.”
Novozymes’ rAlbumins are compliant with the National Formulary (NF) rAlbumin human monograph published by the United States Pharmacopeia (USP). The use of Recombumin Alpha offers a range of performance and quality benefits for these applications, including sustainability of supply, improved biocompatibility and GMP compliance. Novozymes’ also ensures batch-to-batch consistency to reduce processing and testing times to drive product efficiency for customers looking for a compliant albumin alternative.