Advantages Of A CDMO With Internal Biosafety Testing Capabilities

By Ju-young Lee and Wonyong Jeong, Samsung Biologics

Early detection of viruses and mycoplasma prevents cross-contamination, protects the facility, and safeguards product integrity. Accordingly, regulatory agencies require comprehensive virus and mycoplasma monitoring as part of lot release testing. To this end, companies commonly apply three types of biosafety testing: in vitro adventitious virus (IVV), species-specific virus testing such as minute virus of mice (MVM), and mycoplasma.

To better serve our clients and to reduce the time and cost incurred for shipping samples to external testing providers, Samsung Biologics established a large-scale lab, which became operational in December 2019. We now perform over 80% of the testing for products manufactured at our facility. Testing that used to demand up to 50 days to complete via outsourcing now can be accomplished in less than 40 days using internal biosafety testing capabilities.