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Vaccines and Microbiology Products

This work includes GMP product manufacturing, and development and testing of vaccines, components and biotechnology derived products and vaccines.

ReverseGenetics

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 Applicationskey-to-the-future
    • Nucleic Acid Recombinant Technologies
    • Molecular Testing
    • Production Cells and Cell Lines
    • Monoclonal Antibodies
    • Diagnostics

GMPBiotechScientist+Plate+DNA

REDIVAX™ Platform to Accelerate
Quick Response Vaccine Manufacturing


REDIVAXPlatform

(Click to enlarge)

Components to Meet GMP and CMC Needs

Components