Process & product related impurity testing service by LGC

Manufacturer LGC
CMC analytical solutions service from LGC to analyze and identify trace impurities during bioprocessing


Process & product related impurity testing service by LGC product image
Process & product related impurity testing service
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Capabilities

The team at LGC has extensive method development experience using a wide range of state-of-the-art chromatography and mass spectrometry instrumentation. These instruments are used in the development and optimization of analytical methodology for the analysis of process-related impurities to support bioprocess validation, in line with ICH Q6B.

Techniques

  • HPLC and UPLC with PDA, MS, UV
  • GC and Headspace GC with FID, ECD, MS (Agilent 7890B GC with Agilent 5977 MSD)
  • High-resolution LC-MS
  • Waters Acquity H-Class (PDA) with Waters Synapt G2 Q-TOF MS (with Ion Mobility Separation)
  • Waters Acquity H-Class (PDA) with Waters Xevo G2 XS MS
  • Supercritical fluid chromatography (SFC) with PDA, MS
  • Inductively Coupled Plasma with Optical Emission Spectrometry (ICP-OES) - Thermo iCAP7600 Duo
  • Inductively Coupled Plasma with Mass Spectrometry (ICP-MS) - Agilent 7700x and Agilent 7900

The optimized methods can then be validated either as a limit test or full ICH Q2 (R1) validation performed at LGC’s GMP Laboratories.

Applications

LGC can develop methods for the following types of potential impurities listed below, covering all stages of the manufacturing process:

  • Antifoams
  • Antibiotics
  • Growth Promotors
  • Redox Reagents
  • Detergents
  • Process Additives
  • Extractables & Leachables

Host Cell Protein

LGC has the capability to assess host cell protein in both drug substance and drug product as a product-related impurity to support bioprocess validation, in line with ICH Q6B.

Techniques

Elisa based assays:

  • Perkin Elmer Envision Xcite Plate Reader
  • Molecular Devices Spectramax ID5

Product Overview

Process & product related impurity testing service by LGC product image

Process & product related impurity testing service

Manufacturer LGC

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