PharmTech July August 2026

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control.

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.

It is essential to understand how raw material variability can create challenges in process control for autologous adoptive cell therapies.

Documentation reliability across CDMOs, CROs, and other contractors should be engineered into quality systems before, during, and after execution, not patched together at submission or inspection time.

Changes in regulations are reducing costs, expediting approval, and increasing the market for biosimilars.

Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.