Lyophilization Cycle Development

A properly developed lyophilization cycle reduces the cost associated with the drying process and can protect the drug product during drying process and subsequent storage.

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.

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In order for Integrity Bio to develop the ideal lyophilization process, we must 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 changes 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

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