Delta Biotechnology reports that European Medicines Agency (Emea) has granted a marketing authorisation for Sanofi Pasteur MSD's M-M-RVAXpro childhood vaccine (measles, mumps and rubella virus (live)
The vaccine is manufactured using and containing Recombumin, a recombinant human albumin produced by Delta Biotechnology.
Recombumin is a biosynthetic, animal-free material for use in vaccine production and biopharmaceutical formulation.
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.
Recombumin replaces the human serum albumin currently used in Sanofi Pasteur MSD's MMR vaccine.
Following this announcement, Recombumin is the only animal-free, commercially available, recombinant human albumin approved by both the Emea and FDA for use in the manufacture of human therapeutics.
It is a structurally identical, yeast-derived alternative to HSA, which has the potential to improve product acceptance by the regulatory authorities.
Recombumin is manufactured at Delta's cGMP-compliant, Health Canada and FDA inspected facility in Nottingham, UK by a team with over 20 years of leadership and expertise in the development of an animal free biomanufacturing process for the commercial production of recombinant human albumin.
"We are very proud to have gained regulatory approval for the use of Recombumin from both the EMEA and FDA", commented Werner Merkle, CEO of Delta Biotechnology.
"Recombumin has passed the strictest regulatory standards and we are now looking forward to global rollout of our premier recombinant albumin product".
"Our customers can now reap the proven benefits of using animal component free recombinant human albumin in their vaccine production and drug formulation".
"Recombumin provides the industry with an animal-free alternative to human serum albumin".
"We have approximately 30 healthcare companies evaluating its use in their products with several in clinical development in Europe and the US", added Dermot Pearson, commercial operations director of Delta Biotechnology.
