The WuXi Biologics Forensic Analysis & Biophysical Characterization Center of Excellence (CoE) provides high quality particle identification and biophysical characterization to support our clients pursuit of superior product quality and safety. As one of the few dedicated service providers for particulate matter identification and root cause analysis, the Forensic Analysis group has serviced over 200 integrated and 100+ standalone projects, and completed over 1000 particle identification and root-cause investigations. Particle and container closure system (GMP & Non GMP) libraries have been established within the center, which together, allow for comparison and references using the historical data during investigations. The particle library contains optical images, IR spectra and chemical properties of hundreds of different particles.
We provide complete solutions for particulate matter investigation and identification
Our specialized services include but are not limited to:
- Analysis and identification of visible particles in a wide variety of sample types including release and stability samples
- Analysis and identification of unknown contaminants in raw materials, such as metal and colored particles
- Analysis and identification of unknown particles, scratches and residues observed in production equipment and facilities
- Examination and evaluation of faults and defects in production equipment and container closure systems, such as glass shreds
- Examination and evaluation support of unexpected events in manufacturing, such as clogged filters, aggregation, and residual precipitates