Category: Testing Services

Genotoxicity testing refers to the evaluation of detrimental effects of chemical or physical agents on the genetic processes and related hereditary material of living cells. On the other hand, mutagenicity is the process of inducing irreversible and transmissible alterations in the genetic material of organisms either spontaneously or through mutagenic activity. Disruption of the integrity

Considering the rising demand for biologics, innovators in the biopharmaceutical industry are constantly exploring avenues that would enable them to overcome the existing technical and operational challenges related to viral-clearance and testing for timely approval of biologics. Outsourcing the viral-clearance and viral testing studies has emerged as a promising alternative for most of the manufacturers.

According to the US Food and Drug Administration (USFDA), less than 10% of investigational new drug (IND) candidates progress beyond the submission of a new drug application (NDA); this implies that majority of the drug / therapy candidates fail to reach the market owing to unacceptable safety and efficacy profiles and the problems associated with