Formulation: High concentration formulations survey
High concentration formulations can be challenging to develop and there was interest in the Formulations workstream in the comparative approaches taken towards
- Stability testing
- Syringability testing
- The approach to subvisible particles,
- How solubility, aggregation, and particle formation issues are studied
- The challenges associated with high viscosity formulations in PFS,
- The use of needle-free delivery systems or large volume injectors
- Concentration-driven formulation challenges
- The approach to unstable biopharmaceuticals
- How acceptable opalescence is defined
- How Gibbs-Donnan and excluded volume effects for excipients are accounted for, among other more detailed questions.
In total the survey includes the responses from 16 member companies
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