Inspiring Developments

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The biopharmaceutical field continues to evolve at a breathtaking pace, and this issue of BioPharm International® captures that momentum with a mix of strategic insight and hands-on technical guidance. Our cover story, “New Modalities in Biopharmaceutical Development Transform Industry” surveys how pipelines are expanding beyond traditional small molecules to embrace modalities such as cell and gene therapies, RNA therapeutics, and next-generation biologics. The piece explores not only the science propelling these advances but also the operational shifts—flexible facilities, digital twins, and modular automation—that are redefining time to clinic and time to market.

Innovation runs deeper in our Development section, where Laima Trinkūnienė and colleagues examine the latest CRISPR gene-editing nucleases. Their review highlights how tailored editing enzymes, improved delivery vectors, and creative repair templates are addressing specificity and off-target hurdles, setting the stage for safer, more efficient therapeutic candidates. Complementing this forward-looking biology is Jeff Odum’s Downstream Processing Fundamentals column, which tackles a perennial challenge: keeping pace with drug substance demand fluctuations. Odum makes a compelling case for continuous biomanufacturing platforms that scale production up or down with minimal downtime, offering both economic and sustainability benefits.

Manufacturing professionals will find equal value in our feature on the digitalization and automation of aseptic processing. As injectable drug modalities multiply, real-time data capture, robotics, and advanced analytics are becoming indispensable for preserving sterility and throughput. Meanwhile, our Peer Review article by Thomas Altmann and coauthors opens a two-part exploration of cleaning and disinfection best practices. Their first installment zeroes in on facility and cleanroom operations, offering actionable checklists that translate regulatory theory into day-to-day compliance.

On the analytical front, our Q&A with SK pharmteco CEO Joerg Ahlgrimm surveys the convergence of artificial intelligence, high resolution assays, and sustainability imperatives that are reshaping drug substance testing. Finally, our outsourcing column reminds us that the human element remains central to quality, outlining pragmatic steps for vetting contract employees and consultants so that expertise—not merely availability—drives project success.

Together, these articles embody our mission to integrate the science and business of biopharmaceutical R&D and manufacturing. We hope this issue equips you with both the inspiration to pursue ambitious therapeutic breakthroughs and the practical strategies needed to deliver them safely, efficiently, and compliantly. As always, we welcome your feedback and invite you to engage with our online content and upcoming events.

About the author

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

Article details

BioPharm International®
Vol. 38, No 5
June 2025
Page: 5

Citation

When referring to this article, please cite it as Hennessy, M. Inspiring Developments. BioPharm International 2025 38 (5).