Articles in this Issue
Active pharmaceutical ingredient process development requires comprehensive analytical controls utilizing a wide range of analytical methods. An analytical risk survey program was previously developed to evaluate common risk ...
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Stem cell therapies are transforming the approach to degenerative diseases like osteoarthritis, cardiovascular disease, chronic lung disease, Alzheimer’s, and Parkinson’s. Among the many stem cell types currently being explored ...
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Mike Auerbach
Chiral separation has become a cornerstone of modern pharmaceutical development as the industry increasingly recognizes that enantiomers of chiral drugs can exhibit dramatically different biological activities, safety profiles, ...
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Mike Auerbach
Recent breakthroughs in ionizable lipid engineering represent a paradigm shift in mRNA therapeutic development, transforming what was once a years-long optimization process into a matter of months. These advances center on ...
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Robert Dream
Artificial Intelligence (AI) is no longer just a concept confined to the pages of science fiction or the minds of theoretical thinkers. It has grown into a transformative force that is reshaping industries, societies, and even the...
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The pharmaceutical industry continues to face significant challenges in formulating poorly water-soluble drugs, which constitute most new chemical entities (NCEs).1 Among various solubility-enhancing strategies, amorphous solid ...
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Drug-plasma protein binding is a fundamental parameter in drug development that directly affects how a compound is distributed, metabolized, and excreted. Only a drug’s unbound fraction is pharmacologically active, so accurate ...
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The implementation of Contamination Control Strategy (CCS) under the revised EU GMP Annex 1 has fundamentally transformed how pharmaceutical manufacturers approach sterile drug production. Since the guidelines became effective on ...
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I think the main developments have been the automation of complex processes, the improvement of data accuracy, and ensuring adherence to regulatory standards (GxP). This is what we hear from the top and leading global pharma ...
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The industry must adopt a science-driven, data-informed development strategy. A foundational understanding of the active pharmaceutical ingredient’s (API) physicochemical properties, the matrix characteristics, and the drug’s ...
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The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in March 2025.
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Endotoxin testing is entering a new era with the rise of recombinant reagents, offering a sustainable and scientifically advanced alternative to traditional animal-derived methods. Want to learn how rFC can improve specificity, ...
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Mike Auerbach
When I was about 5 or 6, I got sick. I mean really sick. High fever, rash; the stuff of parents’ nightmares. I remember some of it – being driven to the doctor’s offi ce while lying down in the back seat of my mother’s car, having...
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In June 2024, the European Pharmacopoeia Commission adopted 57 revised monographs from which the rabbit pyrogen test (RPT) was deleted, and it added a new general chapter 5.1.13 on pyrogenicity.
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Direct compression offers a faster, more efficient method for tablet manufacturing by eliminating granulation, drying, and milling steps. The article explores how success with this process depends on selecting excipients that ...
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