Quality Control

Viral Safety Testing

Viral Safety Testing

For all stages throughout the development, manufacturing and release of your biological product, Eurofins Lancaster Laboratories offers comprehensive, fully cGMP-compliant Viral Safety Services.

Why Choose Eurofins Lancaster Laboratories?

  • With more than 50 years of combined viral safety experience, our technical staff provides you with the technical advice to ensure that your study design and execution is in compliance with FDA, ICH and EU Guidelines for Viral Safety Evaluation.
  • In addition to our Virology Services, we provide a seamless transition to any supporting services you may require, such as Microbiology and Molecular and Cell Biology—all fully cGMP compliant.

Viral Safety Services

Eurofins Lancaster Laboratories offers comprehensive Viral Safety Services that are available for:

  • Characterization of Cell Banks
  • Unprocessed Bulk Testing
  • End of Production Cells
  • Raw Materials Testing

Instrumentation

  • Segregated virology and cell-culture laboratories.
  • HEPA filtered laboratories maintained at differential pressure for isolation and control
  • Validated cleaning disinfection and environmental monitoring programs

Available Viral Assays

All assays performed in-house are fully validated according to ICH Q2:

Adventitious Viruses

  • In Vitro Assays (multiple cell lines are available for Mouse-, Hamster- and Human-derived products)
  • In Vivo Assays

Specific Viruses

  • Bovine Viral Assay (according to 9 CFR 113)
  • Porcine Viral Assay (according to 9 CFR 113)
  • qPCR Assays

Retrovirus Assays

  • XC Assay for Ecotropic Retroviruses
  • S+ L- Assay for Xenotropic Retroviruses
  • Electron Microscopy for Microscopy for Evaluation of Cell Banks and Culture Harvests
  • Co-Cultivation
  • PERT

Antibody Production Tests

  • Mouse Antibody Production (MAP)
  • Hamster Antibody Production (HAP)
  • Rat Antibody Production (RAP)

Contact Us

Request more information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.