Custom Protein Generation

Drug Substance Manufacturing

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

 

Introduction

A forensic analysis center of excellence was established at WuXi Biologics to support our growing CDMO business but also to support the increasing demand for these services from pharmaceutical/biopharmaceutical companies around the world. The need for these services is especially critical in China and throughout the Pacific Rim. Our forensic analysis services (also known as industrial forensics services) focuses on particle analysis and identification and material characterization.

The team is managed by senior scientists with many years’ experience in large pharma/biopharma and supported by the senior leaders of our Analytical Sciences, Quality Control, Quality Assurance, CMC Development, and GMP manufacturing teams. The WuXi Biologics forensic analysis lab is one of the few laboratories that can provide complete analysis and solutions for particle identification and material characterization including establishing investigational pathways and conducting and consulting on root cause studies.

 

Particle Identification Services

As visible particles or particulates are one of the challenging issues in biopharmaceutical manufacturing, the pharmacopoeias of many countries have provided guidelines for the identification and characterization of these particles. Using these guidelines, WuXi Biologics has developed extensive capabilities for identifying unknown visible particles from a wide variety of sources including:

  • Lot release samples
  • Stability samples
  • Contaminants in raw materials
  • Particles and residues on manufacturing equipment and facilities

In addition, the forensic analysis team can examine and evaluate defects, malfunctions or failures of drug devices and containers and support trouble-shooting of process-related abnormal events such as precipitation, filter clogging, and unexpected deposits and residues.


Representative Particle Examples
1
Protein Particles
2
Amorphous Particles
3
Fibrous Particle
4
Glass Fragment
5
Fluffy Particle

Typical Types of Samples
  • Injections or other liquid samples
  • Lyophilized or other powders
  • Glass containers and plastic bottles

 
  • Medical equipment and devices
  • Tablets, capsules, and emulsions
  • Other packaging materials


Key & Technology
  • Stereo optical microscope
  • Infrared microscope
  • Raman microscope
  • Scanning electron microscope/energy-dispersive X-ray spectrometer (SEM/EDS)

 
  • Particle isolation technology
  • Fine particle manipulation micro-tools
  • Huge spectral databases & powerful searching software

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