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

Spotlight

WuXi AppTec: Partner for Reprocessing

With a device that will undergo reprocessing, there are critical steps an..

What to do next? Toxicological Risk Assessment of Analytical Chemistry Data

A biological evaluation is a weight of evidence. It consists of materials..

Reprocessing Studies: Cleaning Instructions Validation and Predicate Devices

When the FDA releases a guidance to the industry, such as the..

Extractables / Leachables Studies: Recommendations and Considerations for Medical Device Pre-submission Testing

Demand for extractables and leachables studies increases as industry and regulatory bodies..

WuXi AppTec Selected by IQVIA Stem Cell Center to Serve as GMP Manufacturer of Advanced Therapies

WuXi AppTec Selected by IQVIA Stem Cell Center to Serve as GMP..

Expedite Entry Into Clinical Trials With The WuXi Hyper-PRO Platform For Viral Vector Manufacturing

Expedite Entry Into Clinical Trials With The WuXi Hyper-PRO Platform For Viral..