Chemistry Manufacturing & Controls

Chemistry Manufacturing & Control (CMC) is a critical element of the drug development process and increases in complexity as the development process matures. CMC includes manufacturing of bulk drug substance and final drug product, setting specifications, release criteria, stability programs, and analytical methods. The Translational Medicine Group provides a critical roadmap to support CMC programs, beginning with a product development plan and continuing with long-term technical strategic planning and execution. We can design a product development CMC plan for your IND submission, as well as select, audit, and manage your contract manufacturing and testing laboratories, other service providers and suppliers. We also provide support on the planning, execution, writing, and publishing of CMC sections for US and international regulatory submissions. Our technical and regulatory expertise provides cost effective solutions for CMC development.

  • Process Development and Validation
    • NCE Synthesis
    • Biologic Fermentation: upstream processes, downstream processes, and master cell bank
    • Combination Products
    • Critical Quality Attributes and In Process Controls
    • Sterilization
  • Formulation Development
  • Development and Justification of Specifications
    • Test Method Development and Validation
    • Stability
    • Impurities
  • Container Closure Systems for Packaging