Safety evaluation of biopharmaceuticals
Safety evaluation of biopharmaceuticals
Mycoplasma Testing
Eurofins Analytical Science Laboratories, Inc. offers comprehensive testing services from from validation, measurement, to method transfer.
Cell culture technology using human and animal cells has been widely utilized not only in antibodies and vaccines, but also in the fields of regenerative medicine and gene therapy.
The regulatory authorities request to perform mycoplasma testing for there biotechnology products and biological products.
Eurofins companies have been focusing on mycoplasma clearance studies for many years, and we have several achievement in filing/approval of pharmaceuticals to the worldwide regulatory authorities. We also have reliable technical data and knowledge.
We propose optimal testing design by utilizing our solid background and technical information.
Viral clearance studies
For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing (Eurofins BPT) network of companies offer comprehensive, fully cGMP-compliant viral clearance services and all of our assays are fully validated to meet regulatory requirements.
Please see our Method development/Release testing pages for release testing of biopharmaceuticals.