Vaccine manufacturing is at the heart of the vaccine industry.
Jane Halpern, Vice President, Regulatory Affairs, Novavax joined us at the World Vaccine Congress 2012 in Washington to detail the new regulatory considerations for vaccine manufacturing.
Novavax is developing a series of recombinant vaccines for infectious diseases using its recombinant nanoparticle platform, a Virus-like particle (VLP) vaccine (influenza) with Nanoparticle vaccines. With a $179 MM contract awarded in 2011 with the Office of Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) for influenza vaccine development, the project is becoming a reality. Current collaborations include Cadila Pharmaceuticals Ltd and LG Life Sciences. Their Rockville, MD facility has a pilot capability that supplies their clinical development and early commercial needs. The important regulatory considerations for this R&D are due to the use of the Sf9 Insect Cell/Baculovirus Expression System, taking into consideration Viral Safety and Influenza Vaccine Production. Production and clinical testing of an RSV F vaccine is also a main concern for regulation.
Why not download the full presentation and see what the new regulatory considerations for vaccine manufacturing are, then tell us you views in the space provided below. Discover more about:
Â· Preclinical and clinical manufacturing support structures for vaccine manufacturers – how mutual cooperation and collaboration is key
Â· Should regulatory standards be the same for both therapeutic and prophylactic vaccine types? What advantages are there in keeping them separate, and what could be gained by uniting them?
Â· How regulatory bodies view innovative manufacturing technologies, and what Pharma/Biotech needs to do to ensure that their efforts to innovate are a success