Asymchem, a global pharmaceutical CDMO, has made strides in large-scale peptide drug production by achieving fully automated manufacturing. The company overcame significant technical hurdles, including equipment scale-up and automation of the formulation system.
 
To address equipment scale-up, Asymchem’s Chemical Engineering Department employed advanced simulation techniques and experimental validation to optimize the design of solid-phase synthesizers. The newly designed structure, currently undergoing patent application, is poised for scale-up to 2000-liter capacity.
 
The automation of the formulation system was achieved through the development of a host computer system that seamlessly integrates with the control system, enabling unmanned production across the entire solid-phase synthesis process.
 
To ensure smooth operation, Asymchem established communication links between necessary systems, eliminating information silos and enabling coordinated control across the entire plant. Additionally, the company designed a constant-pressure solvent delivery system, allowing for automated solvent transfers.
 
Subsequent stages of the production process have also been integrated with the Distributed Control System, and a continuous, high-efficiency concentration system has been developed and optimized.
 
These advancements have significantly boosted Asymchem’s solid-phase synthesis capacity, enabling the company to scale up production to over 10,000 liters. Several production lines have already completed process validations, with some transitioning to commercial technology transfer.
 
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