Testing for viral adventitious agents

The entire panel of in vivo tests for adventitious viruses are available. All assays are GMP-compliant and have been validated according to the following guidelines

• FDA “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals” (1993)
• ICH guideline Q5A (CPMP/ICH/295/95) “Viral safety evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin”
• European Pharmacopoeia 2.6.16 “Tests for extraneous agents in viral vaccines for human use”

Tests can also be performed for adventitious viruses in samples such as purified bulk.  The experimental work is performed in a S2 biosafety lab with individually ventilated cages (IVC).

Upon request, additional analytical procedures and methods can also be validated either under GLP or GMP standards.