CDMO Asymchem has achieved fully automated the therapeutic peptide manufacturing process to facilitate the large scale production of the biologics.
To achieve this, the company had to overcome the equipment scale-up issue.
According to Asymchem, the company had to consider how to achieve an optimal suspension with resin and reactants, as well as a homogenous mixture.
The company also had to pay careful attention to the structural design of the synthesiser.
Asymchem addressed this through the utilisation of advanced simulation techniques and experimental validation, which allowed the company to finalise the design of its solid-phase synthesiser, while also defining the structural characteristics of its stirring paddles.
The resulting structure is currently progressing through the patent application process, with plans to scale it up for use in synthesiser equipment with a capacity of up to 2,000 L.
As well as working on this novel design, Asymchem had to implement an automated formulation system.
The company achieved this, while also developing a host computer system in parallel, allowing unmanned production across the entire solid-phase peptide synthesis process.
Automation of a solid-phase synthesiser is also constrained by adjacent production stages, so it's essential to ensure that solvents are readily available and that products and waste solvents are promptly discharged.
To overcome this, Asymchem's team established communication between necessary systems, eliminating information silos and coordinating control across the entire plant.
In order to further meet automation requirements, Asymchem's team also designed a constant-pressure solvent delivery system, enabling the solid-phase master software to control solvent delivery and allowing the simple management of 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 optimised a continuous, high-efficiency concentration system.
These efforts have allowed the company to enhance its solid-phase synthesis capacity to more than 10,000 L.
[Image credit: Asymchem]
