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AI in GMP: Navigating Evolving Expectations for Regulated Labs
Why 2026 marks the shift from guidance to enforcement and what it means for your organization now. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Regulators are already inspecting AI use, how prepared is your organization? For years, the pharmaceutical industry has anticipated regulatory clarity on the use of artificial intelligence (AI) and machine…
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Unseen Dangers: The Impact of Undetected Particles in Your Cell Therapies
In recent years, cell therapy has emerged as a transformative treatment, providing promising cures and even more potential for treating various cancers and other diseases. However, amidst the optimism, a significant concern looms—the presence of foreign particles in cell therapy. These tiny intruders, often difficult to detect, can pose serious threats to the safety of...
Biophysical Characterization Methodologies
Biophysical characterization of proteins is a necessary step in the production and development of protein therapeutics, as it allows for a comprehensive understanding of a protein’s function and structure. By analyzing and defining the higher-order structure of potential drug targets, this process serves to identify and mitigate issues that could significantly impact the efficacy and safety of a product, such as...
The Importance of AAV Characterization in Ensuring Safe Gene Therapy Development
Adeno-associated virus (AAV) capsids have emerged as frontrunners for in vivo gene delivery thanks to their unique safety profile and ability to provide long-term gene expression. With multiple serotypes of recombinant AAV vectors being utilized across various gene therapy programs, the field is witnessing unprecedented growth. As of April 2020, there are 244 active worldwide...
Why USP 788 Matters: Ensuring Patient Safety Through Particulate Matter Testing in Injections
In the world of pharmaceuticals, strict regulations are crucial for protecting patients and ensuring product efficacy. One significant regulation is the United States Pharmacopeia Chapter 788 (USP 788), which provides guidelines for testing particulate matter in injections. But why is this important? Particulate matter, often too small to see with the naked eye, can pose...
Is it Time to Re-Evaluate U.S. Pharmacopeia Standards? Exploring Y-site Pediatric Drug Administration Compatibility
Navigating the complex landscape of pediatric healthcare, particularly when it involves administering intravenous (IV) medication to children, brings about a unique set of difficulties. The task becomes even more daunting when dealing with critically ill patients who frequently require extensive IV drugs to maintain homeostasis. To put it into perspective, an infant in a neonatal intensive care unit might receive an...
Polysorbate 80: Exploring its Impact on IgG Stability
As drug safety regulations intensify, manufacturers must ensure their formulations, like polysorbate 80, are free from visible particles and contain a limited number of subvisible particles larger than 10 µm (per FDA requirements). These particulates aren’t just due to process instability but also the degradation of formulation excipients. Mechanical stress during manufacturing can cause protein...
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