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Lyophilization – Analyzing the molecular structure with Timegated® Technology

Timegate helps to ensure stable polymorphism in bioproduct lyophilization

Lyophilization involves the removal of water from the produced bioproduct resulting in stable products with extended durability. The process facilitates the transportation and storage of the produced drug.

Lyophilization is suitable for preserving heat-sensitive substances like protein drugs and vaccines, creating parenteral drugs, or making scaffolds. The process involves freezing, sublimating frozen water, and removing unfrozen water. Yet, this process can cause changes in the biomaterials, making them susceptible to denaturation, osmotic imbalance, and mechanical stress. Monitoring these changes requires advanced approaches like process analytical technology (PAT) and biophotonic tools such as Timegated® Raman and near-infrared spectroscopy (NIR).

The removal of water from the bioproduct alone does not guarantee that the molecule structure has remained unchanged

Storing biomaterials and cells long-term through traditional cryopreservation methods poses challenges due to maintenance requirements, space, costs, and the risk of cross-contamination. Another issue is protein alteration during the lyophilization process.

Process analysis: The removal of water does not provide the whole picture of the structure of the therapeutic protein.

Data analysis: While NIR is widely used to monitor water levels, it is not as sensitive as Raman and is unable to detect changes in chemical structures.

Timegated® Technology provides a unique molecular fingerprint, and shows if the molecular structure remains the same

Timegate offers tools to monitor the polymorphic structures and detect the possible polymorphic changes during the lyophilization process.

Process analysis:  Timegate offers you the specific molecular fingerprint of the therapeutic protein to monitor the molecule structure.

Data analysis:  Timegated® Raman Technology can help in monitoring the lyophilization process by revealing chemical and physical changes (protein secondary structure and polymorphs). Additionally, the technology can measure the fluorescence lifetime, enabling the monitoring of changes in the environment of the analytes, such as changes in pH or polarity.

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