기술
동결건조 기술
민감한 바이오 소재를 보호하고 보관 안정성을 확장하는 동결건조 공정 개발.
Technology
Lyophilization Technology
Lyophilization, commonly known as freeze-drying, is an important stabilization technology for temperature-sensitive biological materials. The process removes water primarily through sublimation of ice under reduced pressure, followed by removal of more strongly associated residual water during secondary drying. The resulting dry matrix can provide a substantially different stability environment from the original aqueous formulation.
Lyophilization is not simply ‘freezing and drying.’ It is a process-development problem involving formulation composition, freezing behavior, heat and mass transfer, product temperature, chamber pressure and residual moisture.
Process Stage 01
Stage 1 — Freezing
During freezing, water crystallizes into ice while solutes become concentrated in the unfrozen phase. The freezing process influences ice-crystal morphology and therefore the pore structure of the final dried cake.
Freezing conditions can affect
- Product morphology
- Drying resistance
- Residual moisture
- Reconstitution time
- Product stability
- Primary drying performance
Process Stage 02
Stage 2 — Primary Drying
During primary drying, ice is removed through sublimation under controlled temperature and pressure. The product must remain within an appropriate temperature range to avoid undesirable structural changes such as collapse or loss of critical quality attributes.
Process Stage 03
Stage 3 — Secondary Drying
Once most of the ice has been removed, secondary drying is used to reduce residual moisture through desorption. Residual moisture is not simply a parameter to minimize without limit. The appropriate moisture level depends on the biological material and formulation.
Formulation Science
Reconstitution Engineering
For a lyophilized biological product, the development process does not end when the powder is produced. The final product should be evaluated for: