Technical challenges | manufacturability gaps | QbD approaches | modeling and PAT | glassware, bioreactors, wave bags, SUBs | equipment design and selection | partner network
After thorough process baselining has identified the key technical challenges and associated manufacturability gaps for your process, we collaborate with you to define and then execute a development program that takes CMC off the critical path.
We screen process conditions identifying the key process parameters requiring optimization and define strategies to ensure the critical quality attributes for your product can be delivered consistently across scales and manufacturing platforms. We deploy QbD approaches as standard, obtaining deep kinetic and thermodynamic understanding for your processes, leveraging real time analytics and modelling platforms to accelerate development decisions.
Throughout development we evaluate strategies for scale up, to standard or bespoke manufacturing equipment sets, with processes that are well understood and behave robustly across defined design spaces.