The Deepest Process Development Pipeline in the World
We propel molecules through development, with vast experience across early and late phases and into manufacturing.
Our Medicine Pipeline
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Process Definition
We wrap fit-for-purpose processes around your molecule, catapulting it through development.
We strive to understand your clinical landscape and the technical work needed to advance your programs with speed, optimizing challenging steps, solve key technical challenges and providing you with flexible manufacturing options.
Process Development
We develop the process. So the process can deliver for you.
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.
Process Characterization
We prepare processes for fast and effortless manufacturing introduction.
We unlock the insights needed to conduct fast and deliberate process characterization phases through a combination of FMEA risk assessment, CPP classification, and model supported design of PARs and DoEs.
Post-Launch Optimization
We improve processes within the regulatory filing and design new ones for enhanced supply.
We improve inefficient processes, solve every kind of manufacturing challenges and design for the second and third generation.