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Drug Development Process

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  • 1. “ The Biopharmaceutical Drug Development Process ” Clifford S. Mintz, Ph.D. www.bioinsights.com
  • 2. Drug Development Process Discovery Development Clinical Testing Licensure Marketing & Sales Manufacturing
  • 3. Drug Discovery
    • Target identification and validation
    • Production and/or synthesis of “drugs”
    • Interaction between drugs and targets characterized and validated in vitro
    • Tested for efficacy in animal models of disease
    • Technology transferred to development group
  • 4. Drug Development
    • Process of production/synthesis of drug is validated and “scaled up” to produce larger quantities of the drug
    • Detection and analytical methods for the drug are created and validated
    • Toxicology and ADME experiments performed in animals
    • Investigational New Drug Application (IND) is prepared and submitted to the Food and Drug Administration (FDA)
  • 5. Clinical Testing
    • IND is approved by FDA and drug is tested in human clinical trials
    • Phase I trials are conducted to assess drug safety; typically tested in healthy human subjects
    • Phase II trials are conducted to assess drug efficacy in patients suffering from the “target disease”; dosing is determined and numbers of patients in the trials are typically small
    • Phase III trials are conducted to assess overall therapeutic effect of drug in large numbers of ill patients
  • 6. Licensure
    • Data from Phase I-III clinical trials tabulated and analyzed for overall safety and therapeutic efficacy
    • A New Drug Application (NDA) or Biological License Application (BLA) is prepared and submitted to the FDA for review
    • The NDA must contain:
      • All pre-clinical and clinical data
      • Documentation that describes the manufacture, formulation, validation and packaging/labeling of the drug
      • Production facility design and operation
      • Marketing Plan
    • If the application is approved, the company is granted a license to manufacture the product
  • 7. Manufacturing
    • NDA or BLA is approved by the FDA; drug must be manufactured in commercial quantities to meet therapeutic demand
    • Drug is manufactured in protein production facility built and validated by the licensee or via a contract manufacturing organization (CMO)
    • This process is guided by cGMP regulations
    • Manufacturing facilities are initially inspected and then monitored from time to time by FDA
  • 8. Scale Up and Production
    • Commonly referred to as “upstream processing”
    • Expression of recombinant proteins in animal cells, bacteria, yeast and other systems
    • Process is carefully controlled and tightly regulated; must be highly reproducible with as little variation as possible
    • Quality systems management is critical
      • Documentation, e.g. SOPs, validation, batch records, etc.
      • QC & QA
      • Facilities and environmental monitoring, equipment validation, cleaning control, etc.
  • 9. Protein Purification and Recovery
    • Commonly referred to as “downstream processing”
    • Recombinant protein is isolated and purified via a variety of biochemical methods
    • Purified protein is analyzed and characterized by sophisticated analytical methods to insure identity
    • Like the upstream process, downstream processing is carefully controlled and tightly regulated; must be highly reproducible with as little variation as possible
    • Quality systems management is critical
      • Documentation, e. g, batch records, analytical reports, lot numbers are assigned
      • QC & QA
      • Facilities and environmental monitoring, equipment validation, cleaning control, etc.
  • 10. Finished Product
    • Purified recombinant protein is placed into final container via a “sterile fill” process
    • Vial or package are given lot numbers and labeled according to licensing requirements
    • Finished product is shipped from manufacturer to drug distributors and then sold to public
    • Microbiological testing, QC, stability testing and other QA functions are critically important and vital to insure product quality and safety
  • 11. Conclusions
    • The entire drug development process from discovery through licensing takes approximately 10-15 years
    • All aspects of development are very tightly controlled and highly regulated by cGMPs
    • cGMPs play a vital role in the production of safe and efficacious clinical materials and finished drug products
    • Mandatory adherence to cGMPs insures that product quality and safety is maintained through the lifecycle of an FDA-approved drug product