EMEA Adopts Positive Opinion on First European Product Containing Delta Biotechnology’s Recombumin® (recombinant human albumin)

The EMEA’s CHMP has adopted a positive opinion on Sanofi Pasteur MSD’s Marketing Authorisation Application for M-M-RVAXPRO™ (measles, mumps, and rubella virus vaccine (live)) manufactured using and containing Recombumin®, a recombinant human albumin produced and supplied by Delta Biotechnology Ltd, Nottingham, UK.

This development results from collaborative efforts between Delta and Sanofi Pasteur MSD and Merck & Co. to define and test the use of recombinant albumin in the measles, mumps and rubella vaccine production process.

Developed and manufactured by Delta Biotechnology, Recombumin® is structurally equivalent to human serum albumin. For many applications, Recombumin® is a biosynthetic alternative of choice to non-active protein ingredients of animal or human origin used in vaccines, drugs, and diagnostic products. Recombumin® was tested in clinical trials including more than five hundred subjects. The results of these studies demonstrated that Recombumin® was generally well-tolerated.

“This positive opinion is a further milestone in the global rollout of a recombinant albumin product for use in the manufacture of medicines. With the FDA approval last year and now the positive European opinion for use in an s.c. administrated childhood vaccine, Recombumin® has passed the highest possible hurdles” says Werner Merkle, CEO of Delta Biotechnology.

Approximately 30 healthcare companies are evaluating the use of Recombumin® in their products with several in clinical development in Europe and the US. M-M-RVAXPRO™ is the Sanofi Pasteur MSD registered trademark for measles, mumps and rubella virus vaccine live.