This work includes GMP product manufacturing, and development and testing of vaccines, components and biotechnology derived products and vaccines.
Courtesy www.niaid.nih.gov
https://www.niaid.nih.gov/topics/Flu/Research/basic/Pages/ReverseGeneticsIllustration.aspx
Vaccines and components in development include:
- Bacteria
- Viruses
- Cell Substrates
- Adjuvants & Protectants
- GMP Media & Solutions
- Non-Needle Delivery Technologies
Specific capabilities and activities include:
- Manufacturing of vaccines as whole live, killed, subunit, or particulate organisms
- Manufacturing of small and pilot scale sterile liquid fill products
- Formulation and delivery components
- QA and QbD in product manufacturing
- Bioassays, potency, purity and QC release testing for certificates of analysis
- Defining product labeling and packaging
- Cost of goods analysis and pricing
- Reproducibility, stability, product analysis
- Diagnostic products and devices
- Follow-on laboratory studies support
- Consulting: Process and product development
- Biotechnology Applications
- Nucleic Acid Recombinant Technologies
- Molecular Testing
- Production Cells and Cell Lines
- Monoclonal Antibodies
- Diagnostics
REDIVAX™ Platform to Accelerate
Quick Response Vaccine Manufacturing
(Click to enlarge)
Components to Meet GMP and CMC Needs
