Freeze drying cycles should be developed for each formulation or product to ensure that processes are robust and financially efficient.
Developing separate processes will also ensure that they are well positioned from a regulatory point of view. The FDA states:
”A manufacturer that has one cycle for multiple strengths of the same product probably has done a poor job of developing the cycle and probably has not adequately validated their process. Investigators should review the reports and data that support the filed lyophilization cycle.”
The Ideal Cycle
A successful freeze drying cycle will provide reliable, safe processing in an efficient manner.
Each stage of the process – freezing, primary drying and secondary drying – poses its own challenges. Many factors influence the design of the cycle, including the specific thermal characteristics of the product, the type of product the amount of product per batch or container, and the capabilities of the processing equipment to be used.
Biopharma Technology combines a scientific approach to process development with a wealth of experience with the freeze drying requirements of different products.
How it Works
Initial analyses with our freeze drying instruments Lyostat and Lyotherm provide key data about the essential characteristics of the product which are used to draft an initial cycle. A small amount of product is processed with this cycle using our pilot-scale freeze dryers, which are equipped with sophisticated monitoring and data trending capabilities to return information about the progression of the product throughout the process. The dried product is then tested to ensure the required moisture content (dryness) has been achieved, and the cycle refined based on the feedback.
As well as Karl Fischer moisture determination, a range of post-process characterization analyses is available, mDSC, DVS, SEM and XRD.
The Benefits of Our Approach
- A robust, repeatable and efficient cycle
- A final freeze drying program typically returned in only 3 runs – minimal use of time and product
- In-depth product and process data invaluable for quality control or regulatory requirements
- Well positioned to meet FDA guidelines
- Separate dedicated facility for cytotoxic products
QbD is key to producing a robust cycle development process. Watch this short Q&A with Dr. Kevin Ward to find out more about Quality by Design and the benefits it brings to the freeze drying process.