To facilitate large-scale production of peptide drugs, Asymchem (stock codes: 002821.SZ/6821.HK), a leading global pharmaceutical contract development and manufacturing organization (CDMO), has achieved fully automated manufacturing.
One initial hurdle was equipment scale-up. In particular, the optimal suspension and mixing of resin with reactants and the structural design of the synthesizer required careful attention. To address this, Asymchem's Chemical Engineering Department (CED) utilized advanced simulation techniques and experimental validation to finalize the solid-phase synthesizer design and define the stirring paddles' structural characteristics. The new structure is in the patent application process and is planned to be scaled up for use in 2000-liter solid-phase synthesizer equipment.
The implementation of an automated formulation system was an additional challenge. Asymchem achieved this and additionally developed a host computer system that seamlessly interfaces with the control system, facilitating unmanned production across the entire solid-phase synthesis process.
Furthermore, the automation of the solid-phase synthesizer is constrained by the overarching utility systems and adjacent production stages. It is essential to ensure that solvents are immediately available and that products and waste solvents are discharged promptly.
To address this, Asymchem's Center for Intelligent Manufacturing Technology (CIMT) and Center for Continuous Flow Chemistry Technology (CFCT) established communication links between necessary systems. This integration eliminated information silos and ensured coordinated control across the entire plant.
To meet automation requirements, the CED team designed a constant-pressure solvent delivery system. This enabled the solid-phase master software to control solvent delivery from the tank area, allowing the synthesis reactor to automatically manage solvent transfers.
Beyond the solid-phase synthesis system, subsequent stages have been integrated with the Distributed Control System (DCS). Additionally, CED engineers have developed and optimized a continuous, high-efficiency concentration system.
These efforts have significantly enhanced Asymchem's solid-phase synthesis capacity from a few hundred liters to over 10,000. Currently, several lines have completed their process validations, with some having transitioned into the commercial technology transfer phase.
About Asymchem
Asymchem is a comprehensive contract development and manufacturing organization (CDMO) with a complete continuum of support from pre-clinical to commercialization. Founded in 1997, Asymchem offers integrated solutions spanning the entire drug substance and drug product life cycle, backed by cutting-edge technology including flow chemistry and green manufacturing. With R&D and manufacturing operations in China, Europe, and the U.S. and a team of proven experts, we provide a full range of CDMO services for a global client base.
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Contacts:
Jake Knorr
Senior Director of Marketing
Asymchem
Jakeknorr@asymchem.com
