Process development is used to establish, implement, or improve a pre-existing manufacturing process. It ensures a product can be routinely made aseptically and meet specifications before manufacturing at scale. At Akron, we develop and optimize processes to enable the development of commercially-viable products that prioritize quality, affordability, and reproducibility. We establish a minimal industrial process, converting from processes developed on the bench in a research lab to industrial scale processes that take into consideration the necessary upgrades in controlled environment, equipment, and ancillary materials. In every project, we perform a manufacturability assessment and determine the quality level and testing required for production-process controls and released products. We can create new processes, transfer existing processes, or optimize a process from early development onwards. Whether we develop an end-to-end process or optimize specific phases, our goal is to de-risk the manufacture of a final advanced therapy medicinal product.
At Akron, our approach is to conduct numerous runs at scale during process development to inform specifications for the final product. We focus on rigorous development to create a validated process. The outcome is comprehensive documentation that specifies the manufacturing process for an aseptic product and analytical testing—such as validation protocols, reports, batch records, SOPs, and CofT/CofA—that ensure product requirements are met. Characterization packages as well as analytical methods development are also important to process integrity, and ultimately, commercial success. Having a sound and tested process in place before manufacture supports reproducibility, predictability, and consistency.
- Practical Problem-solving – Troubleshooting with sensible solutions to increase quality and reduce costs
- Reproducible Processes – Rigorous development to create robust and validated processes
- Rational Optimization – Controlled iterations to ensure maximum quality, scale, and reproducibility
- Comprehensive Documentation – Thorough package for manufacturing and analytical testing