Analytical Method Development and Validation – A CDMO Perspective

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Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug product by regulatory agencies. In order to receive approval by regulatory bodies, the applicant must prove control of the manufacturing process as well as validate that the methods used to evaluate drug product performance are accurate and precise. For this reason, the analytical methods created during development are a key component of the Chemistry, Manufacturing and Controls (CMC) section of a regulatory filing. Inconsistencies in the analytical method can hinder product and process development, thus delaying submission for regulatory approval and thereby delaying product launch. However, a Contract Development and Manufacturing Organization (CDMO) that understands customer needs, regulatory requirements, and has a proven track record for developing and validating analytical methods can minimize developmental costs and reduce the time to market. Properly validated drug product characterization methods are necessary for regulatory filings, but can also reduce overall turnaround time during scale‐up, clinical release and commercial release.

Pharmaceutical development and biotech companies who outsource product and analytical development should consider the following attributes when selecting a service provider.

The outsourcing partner should effectively:

  • Assess the project scope
  • Provide an accurate and complete quote
  • Assess the method for the drug substance (API)
  • Develop prototypes of formulations or assess pre‐existing prototypes
  • Develop the analytical methods to evaluate prototypes
  • Perform an informal stability to assess prototype performance
  • Prevalidate methods to evaluate specificity, precision, accuracy, linearity, and robustness
  • Validate methods according USP, EP, FDA, ICH guidance documents and governing bodies
  • Transfer and assist in the implementation of the methods in a Quality Control environment that will release the commercially approved drug product