Recombumin® Alpha used by MAQUET CARDIOPULMONARY
in a version of the company’s proprietary BIOLINE Coating
NOTTINGHAM, UK – February 27, 2013 –
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.
For further information on
Novozymes Biopharma’s Recombumin portfolio please visit www.biopharma.novozymes.com
