The EMEA's CHMP has adopted a positive opinion on Sanofi Pasteur MSD's marketing authorisation application for M-M-Rvaxpro made with Recombumin, a recombinant human albumin by Delta Biotechnology
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 of Nottingham, UK.
This development results from collaborative efforts between Delta and Sanofi Pasteur MSD and Merck 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 SC 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.
