BiondVax is declared “a good manufacturing practice (GMP) Company” after passing a European audit; the green light to advance clinical development of its universal flu vaccine, M-001 in the EU
BiondVax passes 2 day European qualified person (QP) GMP audit, a key milestone and pre-requisite to conducting advanced clinical trials in Europe.
Nes Ziona, Israel – October 18, 2012 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today announced that the Company underwent a 2 day QP GMP audit and has passed successfully. The QP GMP audit took place over two days 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. BiondVax’s successful passing of this audit gives the Company the go-ahead to manufacture its universal influenza vaccine, M-001, for clinical trials in the EU.
The COO of BiondVax, Dr Shimon Hassin comments, “European QP audits are known for their rigor and high level specifications. The successful outcome of BiondVax’s QP GMP audit validates the professional nature of our facility, M-001 production process and team. We are ready to move forward with Phase 2 clinical trials of our universal influenza vaccine, M-001, in Europe.”
Dr Ron Babecoff, BiondVax’s CEO, adds, “I am very proud of the BiondVax team, which has transitioned from academic R&D into pharmaceutical professionals. I believe this major achievement will prompt discussions with pharmaceutical companies worldwide to advance clinical development of our universal flu vaccine.”