Process Development & Custom Purification
Isolation of product-related impurities
- Isolation of product-related impurities is very tedious and often a long isolation process will change the impurity itself. We offer the isolation of these impurities using our process knowledge and sophisticated preparative and analytical instrumentation.
- The isolation and characterization of product-related impurities for pre-clinical and formulation/stability studies is an essential regulatory requirement and is particularly important for biologics such as biosimilars.
Process development services
- We can provide services related to feasibility studies and process development for continuous chromatography processes. We typically evaluate the projects, and then provide a quote based on project modules with target milestones. The first module encompasses the technology transfer of analytical methods and batch data, if available. The subsequent modules will deal with screening, a feasibility step, process development and optimization, and a commercial evaluation of cost savings.
