Properly developed lyophilization cycle not only reduce the cost associated with the drying process but also can protect the drug product during drying process and subsequent storage
Lyophilization process development requires good understanding of the following parameters:
- Physical properties of formulations under frozen condition, e.g., glass transition temperature, or collapse temperature, re-crystallization, or devitrification, of excipients, 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
- Lyophilizer capacity and limitation
Each of the following steps can be optimized to achieve the most efficient cycle with good product integrity:
- Freezing and subsequent annealing
- Primary drying
- Transition to the secondary drying
- Secondary drying
Integrity Bio has two laboratory scale lyophilizers and one GMP lyophilizer for process development, scale up, engineering run, and GMP manufacturing of final drug products. Other supporting analytical equipment including subambient DSC and FTIR are crucial for proper cycle development.