Scale-Up and Technology Transfer
Moving from a clinical to a commercial batch size is seldom as simple as it should be. A formulation that worked well on an 8-station pilot press may fail on a high-speed tablet press. The product that formed a perfect cake in a pilot scale lyophilizer may melt back or collapse when dried in a commercial scale machine. To a novice, it may seem that the unexpected is to be expected when scaling up or transferring a process.
PharmaDirections employs long-term industry veterans with experience in process development and scale up for all types of dosage forms. These experts know all the pitfalls and all the ways to avoid them. They will:
- Evaluate the current process for efficiency-enhancing opportunities.
- Evaluate the process for critical transfer/scale-up parameters
- Assess opportunities for in-process monitoring in accordance with PAT principles.
- Design a process transfer protocol to evaluate critical parameters
- Oversee execution of the transfer protocol
- Work with the manufacturer to develop master batch records and other documents
- Oversee batch manufacture at the new scale/site and be on hand to make in-process adjustments if necessary