BiondVax Pharmaceuticals Ltd. has announced that the Company has passed successfully a 2 day QP GMP audit during which the Company`s manufacturing facility, production process, personnel and quality control procedures were examined in great detail.
This demanding certification is a requirement for companies intending to manufacture a clinical grade product for human trials anywhere in Europe and gives the Company the go-ahead to advance clinical development of its universal flu vaccine, M-001, in the EU.
BiondVax Pharmaceuticals Ltd. has also announced that the Company will conduct collaborative studies with MonoSol Rx located in New Jersey, USA, to investigate the activity of BiondVax’s universal influenza vaccine, M-001, when formulated utilizing MonoSol Rx’s PharmaFilm® technology for administration by mouth.
The multiple 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.
Since the film is small and likely stable at room temperature it could even be mailed in the post. These benefits could prove critical in the unfortunate event of an influenza pandemic, when rapid public access worldwide to influenza vaccines is demanded.
The CEO of BiondVax, Dr Ron Babecoff comments, “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. I believe today’s announcements will prompt discussions with pharmaceutical companies worldwide to advance clinical development of our universal flu vaccine”.