Quality, Resilience, and Reinvention in Pharma Manufacturing

High Angle Shot of a Working Desk of an Successful Person in Office with Cityscape Window View. | Image credit: © Gorodenkoff - stock.adobe.com

As the pharmaceutical industry moves through a new era of complexity and precision, one truth remains constant: the foundation of every successful therapy is built on quality, consistency, and thoughtful innovation. From raw materials to regulatory harmonization, every link in the supply chain plays a critical role in ensuring that medicines reach patients safely and efficiently.

In this issue’s cover story, “Poor API Quality Threatens a Healthy Supply,” we highlight a pressing vulnerability in the supply chain. As global demand grows and supply networks stretch across borders, even minor lapses in API quality can ripple into major disruptions—slowing production, triggering shortages, and ultimately impacting patient care. Ensuring API integrity is no longer just a manufacturing concern; it’s a business-critical priority.

Product formulation is another key decision point in development. In “Parenteral Formulation: Deciding When to Go Frozen or Freeze-Dried,” we explore how technical performance, cost, and logistics influence formulation strategies. Whether opting for frozen storage or lyophilization, the choice has long-term implications for stability, transport, and scalability.

As in previous issues, sustainability continues to be a recurring and essential theme. “Sustainability by Design” reviews a renewed focus on how early integration of green practices into process development can optimize performance and long-term viability.

We also turn our attention to cleanroom practices, as “Evolving Cleanroom Procedures and Sterility Challenges” outlines how the rise of personalized and small-batch therapies is pushing the boundaries of existing protocols. In a world where every patient may receive a unique formulation, traditional sterility approaches must adapt.

Meanwhile, the future of pharma workforce development takes center stage in “Authentic Intelligence: Finding Diverse Talent in the AI Age.” The industry is at a crossroads—embracing AI while also addressing longstanding gaps in workforce diversity and retention.

Finally, our Ask the Expert column compares European vs. US GMPs, reinforcing the importance of navigating regional nuances even in an increasingly globalized landscape.

Collectively, this issue captures a pharmaceutical sector focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

About the author

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

Article details

Pharmaceutical Technology®
Vol. 49, No. 4
May 2025
Page: 8

Citation

When referring to this article, please cite it as Hennessy, M. Quality, Resilience, and Reinvention in Pharma Manufacturing. Pharmaceutical Technology 2025 49 (4).