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
Facilities and Equipment
- 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:
- In Vitro Assays (multiple cell lines are available for Mouse-, Hamster- and Human-derived products)
- In Vivo Assays
- Bovine Viral Assay (according to 9 CFR 113)
- Porcine Viral Assay (according to 9 CFR 113)
- XC Assay for Ecotropic Retroviruses
- S+ L- Assay for Xenotropic Retroviruses
- Electron Microscopy for Microscopy for Evaluation of Cell Banks and Culture Harvests
Antibody Production Tests
- Mouse Antibody Production (MAP)
- Hamster Antibody Production (HAP)
- Rat Antibody Production (RAP)