Celliance Enters Agreement With Novozymes A/S To Develop Animal-Free Recombinant Human Albumin
Atlanta, GA - Serologicals Corporation, announced that Celliance Corporation, its wholly-owned subsidiary, has entered into an exclusive agreement with Novozymes A/S to explore the commercialization of Recombinant Human Albumin for use in cell culture media formulations. The agreement commits both companies to an exclusive, long-term supply agreement if specified feasibility mileposts are achieved.
"Drug safety is a key priority for our customers and the introduction of recombinant albumin is an important step forward in our effort to create animal-free products that increase the quality and safety of biopharmaceutical production," said Dave Bellitt, President of Celliance. "Our agreement with Novozymes A/S will enable us to introduce this recombinant alternative for our customers."
Under its Probumin™ brand, Celliance is the world leader in the manufacture and supply of bovine serum albumin (BSA) for numerous applications within the healthcare industry. Its animal-free product Incelligent™ is the leading recombinant human insulin product for cell culture applications to the biotech industry.
"In addition to functioning as a transporter of essential nutrients for cell growth, albumin helps reduce cytotoxicity, damage from reactive species (e.g. free radicals) and shear stress on cells within the bioreactor. These characteristics help to support cell viability and mitigate a common form of cell death called apoptosis. No other single cell culture supplement has the ability to deliver this broad spectrum of benefits within a bioproduction setting," added Bellitt.
r-Probumin™AF will be manufactured by Novozymes using its patented Aspergillus fermentation platform. Aspergillus is a GRAS organism (Generally Regarded as Safe) and has been used by Novozymes for protein production for more than 20 years. No human or animal-origin ingredients are used at any stage of recombinant albumin production including the development and maintenance of the master cell bank. Multiple lots of experimental samples will be available for customer evaluation and qualification during the third quarter this year.
Per Falholt, Executive Vice President and CSO of Novozymes A/S commented: "Recombinant human albumin from Aspergillus is an exciting new project. We are pleased that we have been able to develop a process for production of this important protein based on our proven Aspergillus production platform, and we are excitedly awaiting the final results from the customer evaluation program, where after we will undertake up-scaling of the production process."
"Celliance is a leading supplier of cell culture supplements and the agreement supports Novozymes' initiatives outside our main focus on enzymes and microorganisms", commented Henrik Dalbøge, Senior Director Biotech Business development at Novozymes. "rHSA will in addition strengthen Novozymes' platform of ingredients to the biopharmaceutical industry. "
SOURCE: Serologicals Corporation