Formulation
Finding the right fit
The formulation of a drug substance or product has a major impact on its stability. Finding the right fit for your biological is therefore crucial. A study typically consists of:
- Defining the formulation design space (pH, ionic strength, buffer systems, stabilizers, adjuvant, temperature range)
- Determining the intrinsic stability of the drug substance
- Selecting the type of formulation: liquid or lyophilized product
- Plate-based screening studies of formulations with different buffer and excipient combinations
- Formulation optimization and container compatibility testing
- Real-time and accelerated stability studies (thermal, agitation, freeze-thaw, oxidation, and light exposure)