Microbiology & Vaccine Products

Microbiology diagnostic, preventive, and therapeutic products are developed by INCELL scientists, quality managers, and manufacturing staff alone or with collaborators. The work includes GMP components manufacturing; complex formulation and packaging; identification and testing of live organisms, active ingredients, adjuvants, and excipients; evaluating natural and recombinant biotechnology-derived products; and testing of vaccines.

Graphics provided from National Institute of Allergy and Infectious Diseases.

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
  • Collaborative Planning for Clinical Study Design Testing