CMO Training and Knowledge Transfer Requirements

Identifying problems during the tech transfer process can often stem from multiple sources. Common signals that indicate a failure in the tech transfer process include:Click to read the full article.

How to Monitor CDMO Process Robustness After Launch

Monitoring symptoms of process variability or deviation during manufacturing is essential for maintaining product quality. Professionals should be alert to the following signals:Click to read the full article.

How to Handle Confidential Process Knowledge with CMOs

During a routine batch release for a new injectable formulation, the Quality Control (QC) team noticed discrepancies in the analytical results that deviated from established specifications. Specifically, potency testing indicated…