Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

BiondVax Passes EU Quality Control Audit

Published: Tuesday, October 23, 2012
Last Updated: Tuesday, October 23, 2012
Bookmark and Share
BiondVax signs agreement to collaborate with MonoSol on developing oral delivery for universal flu vaccine M-001.

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”.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Moving Towards a Universal Flu Vaccine
Israeli company reports good results with supplemental shot in elderly.
Monday, December 31, 2012
Scientific News
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
Biomolecular Manufacturing ‘On-the-Go’
Wyss Institute team unveils a low-cost, portable method to manufacture biomolecules for a wide range of vaccines, other therapies as well as diagnostics.
Molecular Switch Aids Immune Therapy
Researchers identify strategy to maximise effectiveness of immune therapy through molecular switch controlling immune suppression.
Novavax RSV F Vaccine Fails Phase 3 Trial
Novavax announces topline RSV F Vaccine data from two clinical trials in older adults.
GSK’s Shingles Vaccine Candidate Shows High Efficacy
The vaccine candidate showed high efficacy against shingles and its complications in adults aged 70yrs+ in phase III study.
Eisai Establishes AiM Institute
The Andover innovative Medicines (AiM) Institute will develop innovative precision medicines for hard-to-treat conditions.
Antibodies that Target Holes in HIV's Defence Identified
Scientists suggest 'holes' in HIV sugar sheild can be targeted by antibodies.
Discovery Could Yield Improved Flu Vaccines
Researchers have discovered a type of immune antibody that can evolve to combat a number of infuenza virus strains.
First Accurate Simulation of a Virus Invading a Cell
For the first time, scientists know what happens to a virus’ shape when it invades a host cell.Understanding how the virus shape specifically changes could lead to more effective anti-viral therapies.
Developing a Vaccine for Sexually Transmitted and Insect-Borne Zika Infections
Prokarium announce the beginning of a programme to develop an oral vaccine against Zika infection.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!