Novozymes and Millipore are to supply animal-free cell culture supplements to the biopharmaceutical industry.
The new products, initially focussed on recombinant human albumin and recombinant human transferrin and marketed under the brand name CellPrime, will be manufactured by Novozymes and sold through Millipore's sales organisation.
"By leveraging the strengths of both companies, we will accelerate the introduction and adoption of innovative new products and enable our customers' to rethink their production processes. This collaboration further strengthens our position as a strategic partner for biopharmaceutical companies and broadens Novozymes' biopharmaceutical product portfolio," Novozymes Biopharma vice president Peter Rosholm said.
Millipore upstream bioprocessing business unit vice president Andrew Bulpin said: "Our expanded relationship with Novozymes broadens our commitment to develop a portfolio of high quality animal-free alternatives that optimise productivity, address drug safety, and ease regulatory approval."
Cell culture supplements help mammalian cells produce the proteins that form the basis of biologic drugs.
Recombinant albumin serves as a carrier of essential nutrients for cell growth and supports cell viability within the bioreactor, while recombinant transferrin is highly efficient at delivering iron, an essential element for cell growth.
With regulations moving towards Quality-by-Design processes, the importance of consistent biological raw materials is a big part of this drive.
As concern continues regarding the use of traditionally used animal-derived products and the transmission of diseases to humans, such as Creutzfeld-Jacob Disease, the move to use animal-free products is being strongly encouraged.
"Given the increased regulatory pressure for use of high quality, consistent, animal-free materials, we anticipate that use of our products will allow for more efficient approval of the medicines in which they are used," Novozymes Biopharma UK marketing communications manager Maree Devine told in-PharmaTechnologist.com.
The CellPrime products have been designed to reduce the risk and ease regulatory concerns for biopharmaceutical manufacturers.
"This will be the first recombinant human transferrin analogue which has been developed for industrial cell culture. There are other recombinant albumin manufacturers but none that can produce a dedicated animal-free rHA at large scale for the industry," Devine said.
Recombinant human albumin and transferrin are manufactured using Novozymes microbial platform, which uses Saccharomyces cerevisiae.
This platform has been used by the company to also manufacture Recombumin, a high-quality recombinant human albumin used as an excipient for formulation.
The products are manufactured at Novozymes manufacturing sites in Copenhagen, Denmark, and Nottingham, UK. The manufacturing capacity at these sites was not disclosed.
Novozymes and part of Millipore, Celliance, entered into a previous collaboration in July 2006, to explore the commercialisation of Recombinant Human Albumin for use in cell culture media formulations.