7
Stages of formulation development
During preclinical drug development (before Investigational New Drug [IND] filing),
characterization and product testing must be defined to ensure that the final
product is safe, effective, and consistent between batches. These activities are
known as CMC: chemistry, manufacturing, and control. In general, CMC for mAb
takes place over approximately 18 months. Activities include the following
5
.
1. Analytical methods development
2. Cell line selection and optimization
3. Purification process development
4. Formulation development
a. Pre-formulation development occurs approximately
4-5 months a er drug discovery. Pre-formulation is the
phase of research and development when researchers
characterize a drug's physical and chemical properties.
b. Clinical formulation development occurs a er pre-
formulation development, approximately 8-9 months a er
drug discovery. This is the phase when scientists finalize
the formula that will be used in clinical trials.
5. Analytical assay qualification and transfer to Quality Control
6. Product characterization
7. Drug substance (DS) production
8. Preliminary DS stability studies
9. Preclinical drug product (DP) production
10. Preliminary DP stability studies
11. IND filing
