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:
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Bacteria
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Viruses
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Cell Substrates
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Adjuvants & Protectants
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GMP Media & Solutions
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Non-Needle Delivery Technologies
Specific capabilities and activities include:
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Manufacturing of vaccines as whole live, killed, subunit, or particulate organisms
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Manufacturing of small and pilot scale sterile liquid fill products
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Formulation and delivery components
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QA and QbD in product manufacturing
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Bioassays, potency, purity and QC release testing for certificates of analysis
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Defining product labeling and packaging
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Cost of goods analysis and pricing
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Reproducibility, stability, product analysis
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Diagnostic products and devices
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Follow-on laboratory studies support
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Consulting: Process and product development
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Biotechnology Applications
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Nucleic Acid Recombinant Technologies
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Molecular Testing
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Production Cells and Cell Lines
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Monoclonal Antibodies
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Diagnostics
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Collaborative Planning for Clinical Study Design Testing
