11.30.22 -- Is Outsourcing Drug Development A Short-Term Solution Or A Long-Term Strategy?

It is incumbent upon pharmaceutical product manufacturers to ensure microbial control in the production environment through environmental monitoring, microbial identification and trending, and the use of proven and continually updated cleaning/disinfectant protocols. These steps must be taken to ensure compliance with applicable regulatory requirements 1-8 intended to ensure the quality of drugs and medical devices and thus patient safety.

Drug producers face increasing stringency from regulatory authorities to substantiate the purity of drug products and to demonstrate control of impurities. Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

Through strategic partnerships and outsourcing strategies, pharmaceutical and biotech companies are enabling acceleration through collaboration. As we look forward to the future of drug development, a panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and in clinical trials — all from one partner. Outsourced testing also ensures biopharma clients can change manufacturing partners between early development and commercial production while having their analytics needs reliably fulfilled in one place.