InVitria’s recombinant human serum albumin is completely animal-free and was developed with financial support from NIH through SBIR grant awards.
Fort Collins, CO, USA, November 30, 2011 / B3C newswire / – The National Institutes of Health (NIH) awarded InVitria a $725,000 Phase II, Small Business Innovation Research (SBIR) Grant to broaden the applications for InVitria’s recombinant human serum albumin product Cellastim®. The Phase II grant was awarded in 2009 as a two-year project, which was successfully completed on-time in 2011. “We are delighted that the objectives of the grant were achieved. The team exceeded those objectives and also implemented cGMP quality standards for manufacturing recombinant human serum albumin,” said Scott Deeter, President. “This is a significant step for our customers and the life science industry.”
InVitria is a Division of Ventria Bioscience, the developer of the ExpressTec® biomanufacturing system. ExpressTec® is the first biomanufacturing system to commercialize recombinant protein manufacturing utilizing plants as the host. InVitria’s product line consists of completely animal-free cell culture media supplements and reagents that are distributed globally by leading distributors in life sciences and cell culture media.
“Several leading biopharmaceutical and cell culture media customers have incorporated InVitria’s recombinant human serum albumin based on the research we performed under this NIH grant,” said Dr. Ning Huang, Vice President, Research and Development and Principal Investigator for the NIH grant award. “There is a strong push from regulators and biopharmaceutical companies to remove serum and animal components from biopharmaceutical manufacturing. The challenge is to maintain cell growth and performance at the same time and Cellastim® makes this possible.”
Animal-derived media components carry safety concerns involving the risk of viral and prion contamination. As a result, regulatory bodies in the US, Europe and Japan have discouraged the use of these components in biomanufacturing. In addition to safety concerns, animal components frequently have high batch-to-batch variation, which leads to unpredictable manufacturing results. InVitria’s recombinant, animal-free supplements support the removal of animal components while maintaining biomanufacturing productivity. The ExpressTec® system enables the cost-effective and animal-free manufacturing of InVitria’s product line.
Cellastim® is the third InVitria product to be manufactured using cGMP quality standards for manufacturing. “We are committed to exceeding our customer’s quality expectations and conversion to cGMP quality standards is a step in this direction. Our customers are some of the most successful biopharmaceutical and life science companies in the world, so their expectations are high. Our expectations are also high and that leads to a successful outcome,” said Greg Unruh, Vice President Manufacturing.
“It appears that Cellastim has the ability to replace animal-derived bovine serum albumin and plasma-derived human serum albumin in cell culture media,” said Brandon Pence, Senior Bioproduction Marketing Manager, Thermo Scientific Cell Culture and Bioprocessing. “We have recognized a growing opportunity for products that are animal-free and have heard this request from several customers. Animal-free culture media offers many advantages in that it alleviates the risk of viral and prion contaminants, including bovine spongiform encephalopathy (BSE).”
The project described was supported by Award Number R44GM079828 from the National Institute of General Medical Sciences. The content is solely the responsibility of the authors (InVitria) and does not necessarily represent the official views of the National Institute of General Medical Sciences or National Institutes of Health.
InVitria develops, manufactures, and markets a portfolio of products used in cell culture, diagnostics, and bioproduction. InVitria’s products address customer needs for defined, animal-free cell culture supplements in stem cell technology, regenerative medicine, biomanufacturing, diagnostics, biopharmaceutical formulation, cell-based vaccines, and general life science research.