Viral Safety Testing
For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully cGMP-compliant Viral Safety Services.
Why Choose Eurofins BioPharma Product Testing?
- 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 BioPharma Product Testing offers comprehensive Viral Safety Services that are available for:
- Characterization of Cell Banks
- Unprocessed Bulk Testing
- End of Production Cells
- Raw Materials Testing
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-, Rabbit-, Bovine-, Insect- and Human-derived products)
- In Vivo Assays (these assays are subcontracted to an approved vendor)
- Bovine Viral Assay (according to 9 CFR 113)
- Porcine Viral Assay (according to 9 CFR 113)
- qPCR 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 Assays
Antibody Production Tests
Antibody Production Tests, such as Mouse Antibody Production (MAP), Hamster Antibody Product (HAP) and Rat Antibody Production (RAP) are subcontracted to an approved vendor.
Request more information to start working with us today.