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  • Achieving Successful Freeze Drying to Prevent Cake Collapse

Achieving Successful Freeze Drying to Prevent Cake Collapse

May 17 2019 Read 293 Times

Freeze drying is a crucial process for a variety of industries, especially pharmaceutical and biotech as it extends the shelf-life of products and makes the material safer and more convenient for transportation.

Many drugs are unstable in solution and degrade rapidly over time, therefore they must be freeze dried to produce a suitable stable product which can be shipped and has an acceptable shelf-life for storage. The freeze dried product can be reconstituted to produce a solution containing the drug ready for administration. Different drugs can be stabilised by freeze drying, these include small molecules but also biological treatments such as vaccines, proteins, enzymes, and other larger molecules.

Freeze drying API/ drug products comes with its own unique challenges and stability issues which need to be overcome. Many biological drug products require additional excipients to stabilise them during the freeze drying process and during storage.

These excipients typically stabilise the drug molecules by entrapping protein molecules in an amorphous matrix which reduces the mobility of the molecule slowing its degradation, and also by supporting the structure of the molecule when freeze dried by replacing the hydrogen bonds interactions of water, which maintain the structure of the molecule in solution, allowing its structure to be maintained once the water has been removed. The resulting product is commonly a freeze dried ‘cake’.

The freeze drying process to produce a ‘cake’ can be broken down into three main stages; freezing, primary drying and secondary drying.

In order to achieve a successfully freeze dried product, the optimised formula which gives you the best results needs to be developed. Biopharma Group can provide you support throughout the formulation development process including your pre-formulation study. With in-house equipment and expertise, Biopharma can perform DSC analysis, freeze drying microscopy (FDM), critical event frozen state analysis, MicroPress cake robustness analysis and much more.

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