3. Key aspects of Chemistry, Manufacturing, Control (CMC) during non-clinical development

Adequate active drug substance must be produced for all non-clinical studies:

  • Small quantities (milligrams to grams) are usually needed for non-clinical studies. Later on in clinical studies and for the market, the production will then be scaled up to produce larger quantities.
  • For Good Laboratory Practice (GLP) studies, the drug substance must be qualified or follow Good Manufacturing Practice (GMP) for each batch produced.

 Some key CMC steps during the non-clinical phase are: