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 provide 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