Analytics, Automation, and Quality Driving the Next Era of Drug Development

The biopharmaceutical industry continues to evolve at a remarkable pace, driven by new modalities, advancing technologies, and the shared mission of delivering safe, effective therapies to patients faster. Each step of development and manufacturing is becoming more interconnected, and this issue highlights the strategies, tools, and innovations shaping the future of the field.

Our cover story examines the growing synergy between formulation and analytics. As Patrick Lavery explores in his interview with Sachin Dubey of KBI Biopharma, integrating advanced analytical methods into formulation development is enabling more precise quality control, greater scalability, and faster innovation.

For next-generation therapies, testing remains a defining challenge. Ambili Menon of bioMérieux emphasizes that cell and gene therapies cannot reach full potential without rethinking quality control. Fit-for-purpose strategies, advanced molecular methods, and strategic diagnostic partnerships are essential to overcoming bottlenecks, ensuring speed to market, and safeguarding product quality.

On the biosimilar front, Kimberly Salgado of ICON plc. underscores how the upcoming wave of biologic patent expirations presents both opportunity and responsibility. Biosimilars represent not only cost savings but also expanded access to life-changing medicines, an industry imperative in the years ahead.

Cynthia Challener provides insights into both upstream and downstream innovation, from harnessing biosynthetic pathways to expanding viral clearance technologies. These efforts reflect how manufacturing science continues to adapt to increasingly diverse and complex biologic modalities.

Equally critical is the focus on quality fundamentals. Our peer-
reviewed article from Ecolab Life Sciences highlights best practices for cleaning, disinfection, and validation, essential elements of compliance, safety, and product integrity. And in this month’s Ask the Expert, leading professionals share perspectives on the regulatory questions shaping operations across the globe.

Together, these features capture the essence of today’s biopharmaceutical landscape: complex challenges, rapid innovation, and unwavering attention to quality. By sharing knowledge and best practices, we collectively advance the mission of transforming scientific discovery into therapies that make a difference in patients’ lives.

About the author

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

Article details

BioPharm International®
Vol. 38, No. 7
September/October 2025
Page: 5

Citation

Hennessy, M. Analytics, Automation, and Quality Driving the Next Era of Drug Development. BioPharm International 2025 38 (7).