Articles in this Issue
Looking back, and in particular, looking at what I have written about in this space over the last year, shows some hits, misses, and some cringy stuff. But, hey, even Babe Ruth struck out – so I’m in good company. No?
Water plays a critical role across the pharmaceutical industry—as a raw material, inactive ingredient, processing aid, and vehicle for medicinal products. It is essential in the formulation and manufacture of dosage forms, active pharmaceutical ingredients (APIs), API intermediates, compendial articles, analytical reagents, and cleaning processes.
In today’s rapidly evolving operational environments, the need for cohesive, integrated, and future-proof fleet strategies has never been greater. The Whole Fleet Concept Design represents a transformative approach to fleet planning, architecture, and lifecycle management – one that breaks traditional silos and enables a more unified, efficient, and strategically aligned operation of assets.
Safety pharmacology occupies a critical, if sometimes misunderstood, niche in the drug development continuum. Designed to evaluate a compound’s undesirable effects on key physiological systems at pharmacologically relevant doses, it bridges the scientific domains of pharmacology and toxicology.
The process is sublime. We all assume that skipping a step in any process can yield suboptimal results. In this case, however, intentionally bypassing the liquid phase of water by going directly from ice to vapor stabilizes a compound without sacrificing its effectiveness, if done correctly. This sublimation is key to freeze-drying or lyophilization, a process that continues to evolve through innovation to play a greater role in biopharma, medtech, and life sciences.
The global market for drug-device combination products presents a significant opportunity, valued at an estimated $139B in 2024 and projected to reach $267.7B by 2032, growing at a compound annual rate of 8.5%.¹ As therapies become more targeted and patient requirements more specific, the demand for specialized delivery systems, including autoinjectors, inhalers and transdermal patches, continues to grow. For drug developers, bringing these innovative products to market requires navigating a demanding path of technical hurdles and stringent regulatory expectations.
Poor aqueous solubility remains one of the most difficult challenges in pharmaceutical development, affecting up to 90% of new chemical entities (NCEs) and over 40% of those in reformulation. Low solubility impairs dissolution, absorption, and pharmacokinetics, resulting in poor bioavailability, increased formulation complexity, and a higher risk of failure to bring a promising drug to market.
The biopharmaceutical industry faces ongoing pressure to deliver new therapies to patients as quickly and efficiently as possible. To accomplish this, manufacturers need to develop and optimize cost-effective production processes without compromising quality or safety.
High-frequency automated process data in modern biopharmaceutical manufacturing provide unparalleled visibility but also present new challenges for process monitoring.
Oxidation control strategies for sensitive phosphine ligands in a GMP setting
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in August-September, 2025.
With the end of 2025 approaching, we have compiled a list of this quarters top tech.
Pharmaceutical manufacturers are facing a perfect storm of challenges. Aging populations in advanced economies are shrinking the pool of qualified laboratory personnel, while the volume and complexity of quality control (QC) testing is growing—especially with the rise of biologics and advanced therapies.