Nottingham, UK (September 1, 2010) Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, today announced that the US Food and Drug Administration Center for Biologics Evaluation and Research (FDA / CBER) has accepted a Type IV Master File for its recombinant albumin, albucult®. The dossier which contains proprietary information on the manufacture and safety of albucult, can help support the company’s customers in applications such as drug formulation and medical devices. By providing customers with access to a single source of information filed with the FDA as part of their product applications, Novozymes can help to accelerate the regulatory process for products that use albucult.
Derived from Novozymes’ proprietary yeast expression technology, albucult delivers unprecedented performance and quality benefits to a range of applications including drug and vaccine manufacture, device coating, sealants, IVF media and cell therapy applications. albucult complies with the excipient monograph standard for recombinant human albumin, published in the United States Pharmacopoeia – National Formulary (USP-NF) and confers a range of unique advantages including sustainability of supply and improved biocompatibility. In addition, albucult ensures batch-to-batch consistency which can significantly reduce lot testing burden for clients.
Wayne Prestwood, principal regulatory associate at Novozymes Biopharma, comments: “The company is always looking for the most effective ways of supporting our customers’ applications through regulatory processes and we are delighted to have a master file for albucult accepted by CBER. By ensuring that the information required by the FDA as part of our customers’ review processes is readily available, we can help speed up their regulatory approvals, enabling their products to be delivered to market faster.”
To learn more about Novozymes’ albucult please visit www.biopharma.novozymes.com
Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.
With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace.
Novozymes’ natural solutions enhance and promote everything from removing trans fats in cooking, to advancing biofuels to power the world tomorrow. Our never-ending exploration of nature’s potential is evidenced by over 6,000 patents, showing what is possible when nature and technology join forces.
Our 5,000+ employees working in research, production and sales around the world are committed to shaping business today and our world tomorrow.
Sally Vernon, Customer Communications Manager
Press and media:
Tel. (direct): +45 4446 0690
Tel. (mobile): +45 3077 0690
Tel. (direct): +45 4446 2274
Tel. (mobile): +45 3077 2274
Paige Donnelly (USA)
Tel. (direct): +1 919 494 3209
Tel. (mobile): +1 919 218 4501
Tel. (direct): +45 4446 8682
Tel. (mobile): +45 3077 8682
Thomas Bomhoff (USA)
Tel. (direct): +1 919 494 3483
Tel. (mobile): +1 919 649 2565