Designing and scaling up a microsphere formulation can be present significant challenges requiring extensive knowledge in pharmaceutical development and process and polymer chemistry. Scaling up a microsphere formulation can bring problems that don’t show up at lab scale, including residual solvent, shifts in particle size, lost encapsulation efficiency and changes in drug release. This presentation explains Oakwood’s continuous manufacturing approach to scale-up. It covers selection of the lead feasibility
formulation, solvent exposure studies, scaling of flow rate and batch size, and terminal sterilization. Several case studies show how polymer selection and processing parameters drive product performance.
You'll learn how to:
- Identify the most common problems in scaling up microsphere formulations and explain what causes them
- Assess how polymer selection and processing parameters affect encapsulation, release kinetics and stability for both peptide and small molecule drugs
- Judge whether terminal sterilization is a practical option for a microsphere product, and what effect it has on product quality