Continuous manufacturing of APIs and intermediates under cGMP. A multi-step case study involving a modular continuous plant, and new opportunities for 3D printed reactors.

Continuous manufacturing of APIs and intermediates under cGMP. A multi-step case study involving a modular continuous plant, and new opportunities for 3D printed reactors

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Overview

This White Paper reviews opportunities to accelerate development workflow, optimize purity and yield, and reduce capital investment through the application of modular concepts for the continuous manufacturing of APIs or advanced intermediates under cGMP conditions. A new modular continuous plant (MCP) with sufficient design versatility to facilitate rapid, cost-effective manufacturing under cGMP conditions is discussed. As a case study, the development of continuous manufacturing process utilizing Continued Stirred Tank Reactors (CSTR) for Grignard formation and continuous crystallization as well as a PFR for the addition to an electrophile is reviewed. Emerging continuous manufacturing process opportunities arising out of the development of 3D printed reactors are also highlighted.

Key Objectivesï¼š

Core Advantages in the Continuous Manufacturing for APIs
Developing a robust process development workflow for continuous manufacturing
Modular continuous plants for cGMP manufacturing of APIs and advanced intermediates

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