Centers Of Excellence

Forensic Analysis

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

Typical particles
Instruments and techniques
Case Studies

WuXi Biologics Forensic Analysis of Particles

WuXi Biologics Instruments for Forensic Analysis

Precision particle handling tools
Well-controlled particle manipulation technology
Huge commercial & internal database for IR and Raman spectra
Extensive industry experience & support for root-cause research

Case Study 1: Uncountable white visible particles in DP stability samples

WuXi Biologics Forensic Analysis Case Study 1: Uncountable white visible particles in DP stability samples

Case Study 2: Unexpected events in manufacturing : flake-like particles observed in DP products

WuXi Biologics Forensic Analysis Case Study 2: Unexpected events in manufacturing : flake-like particles observed in DP products

For an extensive look at all our case studies, please visit our Case Studies Page.