Development of novel manufacturing systems
Scale-up of a laboratory process to a novel manufacturing system suitable for continuous manufacture.
Taking a laboratory process and scaling it up such that it is suitable for mass production can often be a challenge, but particularly when the manufacturing must take place in the absence of oxygen. Sagentia had to create and implement some novel solutions to generate and maintain the low oxygen environment required throughout the process. The resulting pilot system was designed with continuous manufacture in mind, giving careful consideration to ensuring process uniformity for each product.
We were challenged to take a novel lab-scale manufacturing process, and scale it up to a full GMP pilot line, capable of producing product for use in clinical trials.
Initial concepts were generated to develop the novel processing steps required, which critically had to take place in an oxygen-free atmosphere. An extensive phase of proof-of-principle experimentation followed, de-risking all important technical aspects of the process. This included replication of a lab-scale system to enable Sagentia to understand the parameters and facilitate knowledge transfer from the development scientists. In certain areas, multiple concepts were tested in parallel in order to determine the best solution to take forward to detail design. The findings from the testing were incorporated into the design of a pilot production line with consideration of future scale-up and developed to cGMP standards. Sagentia built and conducted a thorough testing program, which culminated in FAT-testing the system prior to delivery to a CMO site.
Timelines were critical for clinical trials, and our fast-track development enabled aggressive schedules to be met, as well as yielding a system which is a positive move towards a continuous manufacture model for pharmaceuticals.