Long-term stability in aqueous matrix can be difficult to maintain due to hydrolysis and other mechanisms of degradation.
Final dosage forms are frequently lyophilized to:
- Improve stability.
- Support shelf life.
- Retain long-term potency.
- Enable storage in ambient conditions.
- Simplify transportation & storage.
- Refine preparation of the administrable dosage form.
Lyophilization Process Development & Clinical Trail Manufacturing Capabilities
Our team of formulation experts design lyophilization cycles using both the develop of experiments (DoE) approach and SMART. This process is performed in an iterative manner in parallel with product formulation development.
Development of the lyophilization process requires a thorough characterization of the drug substance (small molecule or biologic) and lyophilates to remove the necessary solvent molecules without disrupting or degrading the target species.
The formulation composition impacts the development of the lyophilization cycle in that different materials require different temperatures, sublimation rates, and processing steps and duration. The ideal range for moisture content must be determined and maintained during storage to prevent degradation, particularly for formulations without stabilizers.
As reconstitution of the drug product is a key evaluation parameter, the speed and reproducibility of reconstitution will be assessed throughout process development. Various reconstitution media may be evaluated. Lyophilization process development also includes the selection of the appropriate container/closure system. We conduct compatibility studies with the selected container/closure system(s) upon selection of final formulation and process parameters.
Our process and operational parameters transfer seamlessly, whether it is to our clinical trials manufacturing site or the commercial product manufacturing site. The optimized, the freezing, annealing, primary drying and secondary drying process parameters and operational parameters are an easy technology transfer to our clinical trials manufacturing sites in Salem and New Hampshire, or the provided commercial product manufacturing facility.