Speed is the key motivation for the manufacture of new pharmaceutical molecules using continuous processing technology. It enables challenging or safety-critical transformations as quickly and safely as usual transformations. A high level of process understanding can be gained by using tools such as Process Analytical Technology PAT, Digital Twins, and Model Predictive Control (MPC) enabling a more data-driven, quick, and reliable scale-up. This is supported by operating lab-scale experiments such as the kilo lab but using scalable equipment.
The use of methods like Design of Experiments (DoE) and process simulation tools support the activities from the process development phase to the start-up of the continuous manufacturing plant.
Generic pharma companies typically benefit from superior processes with significantly fewer unit operations by reducing work-up and washing steps and telescoping processes. In a bid to increase atom economy, second-generation processes typically benefit from a reduction of the solvent amount or a switch to greener solvents.
Contract or Toll Manufacturing/CDMO/CMO
The challenge of contract manufacturing is to respond to a manufacturing demand of various APIs in a short time period which is enabled by utilizing a flexible modular plant infrastructure.
Continuous processing enables the production of molecules with challenging transformations, as well as the use of additional flow reaction modules in a batch infrastructure to increase the capacity of the production facility. In-situ synthesis of reagents enables the use of highly hazardous reagents and can increase plant capacity by using specific modules sometimes named “Reagent Generators”, freeing up vessels to be used for other things.
Specialty and Fine Chemicals Industry
Synthesis of specialty and fine chemicals using flow chemistry and process intensification is typically driven by cost optimization. Typical benefits of using continuous manufacturing technology include cheaper reagents, reduced workup, and a high level of automation providing excellent process control.
Debottlenecking projects deliver increased productivity. Flow chemistry and process intensification boost process efficiency and safety for specialty and fine chemicals manufacturing.
Polymerizations are typically very exothermic reactions. Therefore, good control of the heat release is essential for safe operation to avoid potential runaway reaction conditions. Common batch vessels typically generate a relatively broad molecular mass distribution due to the varying process conditions during production. Flow chemistry allows for quick polymerization reactions with a high level of safety and a high degree of control of optimal process conditions. Increased heat transfer enables a controlled continuous polymerization with a high degree of predefined specific process parameters. A flexible plant design enables the manufacture of highly complex products. It is possible to control the molar mass distribution/polydispersity with different technological solutions.