Solutions

Over the past decade, many pharmaceutical companies have developed and implemented continuous manufacturing technologies. However, these efforts are very different in nature and scope (see figure below), with varying degrees of risks and benefits.

 

continuous manufacturing of pharmaceuticals

Risk vs. Reward for Different Continuous Manufacturing Efforts

Whereas many companies are using single continuous unit operations in otherwise batch processes (A) or integrated solutions for part of the manufacturing process (B), CONTINUUS is leveraging end-to-end ICM, which integrates both the upstream production of API and the downstream formulation steps into a single seamless continuous process (C). Critical enabling components include:

    • Integration Strategy. This requires a deep process understanding to identify all the Critical Process Parameters (CPPs) that impact the final product’s Critical Quality Attributes (CQAs). Control loops based on real-time monitoring of CPPs maintain the CQAs within their required specifications.
    • Plug-and-Play Strategy. Continuous unit operations need to be flexible to be used to process many different drugs/drug classes. In addition, for each step, different units may be needed (e.g., plug flow reactor vs. continuous stirred tank reactor), depending on the compound’s properties and process conditions.
    • Novel Continuous Unit Operations. New unit operations that are continuous in nature allow integration and enhance system performance. Currently, many “continuous processes” are utilizing batch-based technologies.
    • Integrated Control Strategy. The control system is critical, as ICM processes run fully automated. The control system continuously receives information from PATs and sensors, issuing immediate precise corrective actions that maintain the process in a state of control

    By leveraging different aspects of ICM, CONTINUUS Pharmaceuticals is able to offer clients a range of solutions, based on the specific requirements.