EMEA approves vaccine containing Delta's recombinant human albumin
green light to market a childhood vaccine containing Delta's
Recombumin, a recombinant human albumin which offers the world's
first and only animal-free alternative to human serum albumin
(HSA).
The measles, mumps and rubella (MMR) vaccine will be marketed in the EU by Sanofi Pasteur under the name M-M-RVAXPRO following the approval last year of Merck & Co's MMR vaccine in the US, also made with Delta's Recombumin.
Vaccine makers have shown interest in Recombumin because of the continual concerns over potential viral and prion contamination from animal derived materials, with regulatory authorities recommending that drug and device manufacturers seek alternatives to all components of animal origin.
Recombumin is structurally identical to HSA but is made in yeast using a high-yielding production system that is free of animal components.
Dermot Pearson, Delta's commercial operations director, would not provide details of Recombumin's production but told In-PharmaTechnologist.com it is made using commonly applied techniques widespread in the biomanufacturing industry.
"Recombumin consistently meets our exceptionally demanding purity standards and delivers confidence in batch to batch consistency," he said.
"Our pricing structure is consistent with the regulatory, quality and marketing benefits that our product offers over traditional materials."
With an 8,000 litre fermentation capacity, Delta manufactures Recombumin using Saccharomyces cerevisiae, which have a long track record in the production of protein therapeutics such as insulin.
The company has developed a series of S. cerevisiae strains with various traits such as genetic stability, high copy number expression plasmids, protease deficient mutants and strains deficient in the enzymes involved in O-linked glycosylation.
Based on a proprietary 2-micron plasmid construct, the system is optimised for the production of recombinant proteins where glycosylation does not naturally occur or can be designed out without impacting product efficacy.
Recombumin is manufactured at Delta's current good manufacturing practice (cGMP)-compliant facility in Nottingham, UK.
Pearson stressed that Delta is the sole manufacturer and distributor of Recombumin, and that no outsourcing opportunities are available.
Apart from Merck and Sanofi Pasteur, Delta has made several deals for Recombumin, including with Vitrolife in Sweden for the supply of Recombumin for IVF media manufacture, with Novalung in Germany for the supply of Recombumin for medical device manufacture, and ConjuChem in Canada for the supply of Recombumin for clinical development.
Delta also claims it has approximately 30 pharma and biotech companies currently evaluating Recombumin in their products with several in clinical development in Europe and the US.
Looking to improve safety, preparation and storage, many drug companies have shown interest in new formulations of albumin.
Last year the US Food and Drug Administration (FDA) approved Baxter's Flexbumin, the first human albumin preparation to be packaged in a flexible container, reducing the risk of breakage while being more compatible with hospital inventory storage systems.
