Back to Search
Start Over
Technology transfer and scale-up of the FlublokĀ® recombinant hemagglutinin (HA) influenza vaccine manufacturing process
- Source :
- Vaccine. 32:5496-5502
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- Multiple different hemagglutinin (HA) protein antigens have been reproducibly manufactured at the 650L scale by Protein Sciences Corporation (PSC) based on an insect cell culture with baculovirus infection. Significantly, these HA protein antigens were produced by the same Universal Manufacturing process as described in the biological license application (BLA) for the first recombinant influenza vaccine approved by the FDA (Flublok). The technology is uniquely designed so that a change in vaccine composition can be readily accommodated from one HA protein antigen to another one. Here we present a vaccine candidate to combat the recently emerged H7N9 virus as an example starting with the genetic sequence for the required HA, creation of the baculovirus and ending with purified protein antigen (or vaccine component) at the 10L scale accomplished within 38 days under GMP conditions. The same process performance is being achieved at the 2L, 10L, 100L, 650L and 2500L scale. An illustration is given of how the technology was transferred from the benchmark 650L scale facility to a retrofitted microbial facility at the 2500L scale within 100 days which includes the time for facility engineering changes. The successful development, technology transfer and scale-up of the Flublok process has major implications for being ready to make vaccine rapidly on a worldwide scale as a defense against pandemic influenza. The technology described does not have the same vulnerability to mutations in the egg adapted strain, and resulting loss in vaccine efficacy, faced by egg based manufacture.
- Subjects :
- Insecta
business.operation
Influenza vaccine
Hemagglutinin (influenza)
Hemagglutinin Glycoproteins, Influenza Virus
Biology
Protein Sciences
Influenza A Virus, H7N9 Subtype
Virus
Cell Line
law.invention
Bioreactors
Technology Transfer
Antigen
law
Animals
Vaccines, Synthetic
General Veterinary
General Immunology and Microbiology
business.industry
Public Health, Environmental and Occupational Health
Insect cell culture
Vaccine efficacy
Virology
Recombinant Proteins
Biotechnology
Infectious Diseases
Influenza Vaccines
biology.protein
Recombinant DNA
Molecular Medicine
business
Baculoviridae
Subjects
Details
- ISSN :
- 0264410X
- Volume :
- 32
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....17953b9bbed9632bf513e57efb5afd64