Ensuring The Raw Material Data Package Supports Regulatory Filings

The license holder is responsible for data reliability — full stop. Sponsors have two levers to manage that with their CDMOs: the quality agreement and auditing, Lawrence Thompson says in this segment of Cell & Gene Live "Viability On The Line." Your contractor may be responsible for development, but you are responsible for the outcome.

When managing change, Yan Zhi said you should treat raw material almost like the final product. If any of them change, it triggers a comparability study and another risk assessment.