How Innovation and Risk Management Are Reshaping Modern Drug Manufacturing

The pharmaceutical sector continues to evolve at a remarkable pace, shaped by scientific breakthroughs, growing operational complexity, and heightened regulatory expectations. This issue highlights the industry’s ongoing effort to balance innovation with control—ensuring that as technologies and therapeutic modalities advance, manufacturing and quality systems advance alongside them.

Our cover story, “How a ‘Plan, Prevent, Prove’ Approach Helps Avoid Facility and Equipment Problems,” captures a core challenge for good manufacturing practice operations today: anticipating failure before it occurs. As facilities become more interconnected and equipment more sophisticated, risk-based planning and disciplined maintenance have become essential.

On the development front, Cynthia A. Challener, PhD, examines the increasingly complex world of highly potent APIs in “Trends and Challenges Impacting Highly Potent API Development.” The rising demand for targeted and potent therapies is driving investment in containment technologies, specialized infrastructure, and new approaches to worker and product safety. These pressures are reshaping how companies think about HPAPI innovation and scale-up.

Challener also explores the manufacturing implications of these shifts in “Leap Forward in Automation Anticipated for Small-Molecule Drug Product Manufacturing.” With formulation complexity growing and the need for efficiency intensifying, small-molecule manufacturers are turning to automation to reduce manual operations, enhance consistency, and streamline production timelines.

In “How Therapeutic and Analytical Advancements Help Drug Substance Testing Evolve,” Patrick Lavery highlights how advances in both therapies and technologies are redefining modern analytical strategies. He explores trends in sustainability, stability testing, and the emerging role of artificial intelligence in quality assessment. Rounding out the issue, the Ask the Expert feature offers an overview of batch recovery fundamentals, an essential reminder that strong foundational practices remain critical, even as the industry embraces new tools and capabilities. Together, these articles reflect an industry in transition, committed to innovation while ensuring safe, reliable, and forward-looking pharmaceutical production.

About the author

Mike Hennessy Jr is Chairman and CEO of MJH Life Sciences®.

Article details

Pharmaceutical Technology®
Vol. 49, No. 9
November/December 2025
Page: 8

Citation

When referring to this article, please cite it as Hennessy, M. How Innovation and Risk Management Are Reshaping Modern Drug Manufacturing. Pharmaceutical Technology 2025 49 (9).