U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

extractables/leachables

Analytical Chemistry Services

Getting accurate chemical characterization data that targets your particular needs at each stage of product development is critical. But the choices for the materials and chemical evaluation are nearly endless and there is little regulatory guidance available, so developing the right program can be a daunting process.

WuXi AppTec’s experts understand the issues unique to performing materials and chemical characterization for biologics, medical devices and combination products. We have experience testing process disposables and product development and raw materials through finished products. We’ll help you develop an evaluation program to speed your product development process – designed to meet your needs and scaled to fit your scope.

chemviewAnd with our cutting-edge equipment, highly trained technicians and sophisticated assay designs, WuXi AppTec can generate the most relevant data possible. We are proud to have industry-leading identification through our proprietary chemical identification database. This means our reports have few if any unknowns—keeping additional requests for testing or safety concerns at bay.

Services

To meet your particular needs throughout your product development life cycle, we can perform studies as basic as simple IDs or as complex as highly comprehensive quantification and identification programs.

Extractables/Leachables for Biologics »

Extractables/Leachables for Medical Devices »