Every product has different process requirements. Product collapse, the most serious processing failure, affects shelf life, stability and activity, but is not always visually apparent. Even small adjustments made in formulation or equipment can have much greater impacts on process requirements after scale-up which may mean product and cycle are no longer harmonized. In order to determine the effectiveness of a freeze drying cycle, the process parameters must be analyzed with reference to the characteristics of the specific intended formulation.
Biopharma Group combines a science-based approach to process development with a wealth of experience of the freeze drying requirements of different products. Our Lyophilization Process Review service gives you access to the expertise of our team of freeze drying scientists. This service is recommended if you’re approaching scale-up, have changed your formulation or production equipment, or are preparing for a regulatory submission.
How it Works
A liquid sample is analyzed using freeze drying microscopy to identify its most important thermal characteristics, including collapse temperature or eutectic temperature. A printout of the intended cycle is then compared to this data to ensure that processing temperatures are safe, and to identify any areas that would benefit from optimization.
The residual moisture content of five dry samples is ascertained using Karl Fischer Titration and compared to the target specified by the customer. Any significant variation in residual moisture content across a freeze dryer shelf may indicate that the process would benefit from being fine-tuned for added robustness.
Materials to Supply
In order to carry out this service, we require:
- 1 wet sample (pre-lyo if possible)
- 6 freeze dried samples taken from locations across the freeze dryer chamber
- A printout or other record of the freeze drying program used to dry the above samples
- Your target residual moisture content
Detailed Report and Explanation
On completion of the work, the lead scientist will schedule a telephone call to talk through the findings and provide an opportunity to ask any questions. All the data and conclusions will also be detailed in a full written report, including the results of product analyses which can be used for further development work, QC and regulatory submissions.