recently announced that it passed an intensive two-day QP GMP audit – giving it a green light to advance clinical development of its universal flu vaccine
, M-001, in the EU. This demanding certification is a requirement for companies intending to manufacture a clinical grade product for human trials anywhere in Europe.
Universal flu shot (Shutterstock.com)
“I am very proud of the BiondVax team. The universality and immunogenicity of our universal influenza vaccine, M-001, has been demonstrated in animal models and in human clinical trials. Now our success in passing the QP GMP audit demonstrates the professional nature of our facility, M-001 production process and team,” said CEO of BiondVax, Dr. Ron Babecoff. “I believe [the] announcements will prompt discussions with pharmaceutical companies worldwide to advance clinical development of our universal flu vaccine.”
BiondVax, an innovative biopharmaceutical company developing a flu vaccine designed to provide multi-season and multi-strain protection against most human influenza virus strains, also announced that it will conduct collaborative studies with MonoSol Rx located in New Jersey, to investigate the activity of M-001 when formulated utilizing MonoSol’s technology for administration by mouth. Advantages of an oral universal influenza vaccine include ease of delivery and increased compliance, due to the absence of needles, as well as ease of distribution.