In order for Integrity Bio to develop the ideal lyophilization process, we understand the following regarding your project:
- Product integrity during lyophilization: stability indicating assays, FTIR structural analysis
- Physical properties of formulations under frozen condition, e.g., glass transition temperature or collapse temperature, re-crystallization or devitrification, and eutectic melting temperature of excipient in the unfrozen fraction
- Presence of key stabilizers, e.g., surfactant, water-replacing glass formers
- Potential pH change during freezing due to selective crystallization of buffer components
- Phase separation of key ingredients during freezing
- Desired final moisture content
- Vapor pressure of ice at desired product temperature