EDITORIAL SECTION

Articles

10 Effective Strategies to Reduce Water Waste in Pharmaceutical Manufacturing

Water is a resource of great concern to pharmaceutical manufacturing since it is essential in the cleaning of equipment used in manufacturing operations as well as in drug formulations Nevertheless the pharmaceutical industry presents another leading water consumer and therefore reduction of water wastes should be at the top of the agenda regarding sustainability

How Predictive Maintenance Reduces Downtime in Pharma Plants

The pharmaceutical industry is always under stress to enhance the reliability of the production adherence to the regulations and quality of the products without raising the prices and to maintain a continuous supply Machinery malfunctions are not merely a setback in this highstakes game they may compromise batch integrity postpone life and death treatments and put pressure on the market promises

AI-Native Pharmaceutical Manufacturing: Transforming the Smart Factory

Most European manufacturing leaders have already paid for a smart factory Sensors were installed historians consolidated execution systems layered over the batch record and dashboards commissioned and mounted on shopfloor screens The plant became visible What it rarely became was decisive Information now moves faster than it did a decade ago yet the decisions that carry real cost and risk

Fundamentals of Clinical Pharmacology: Understanding Drug Actions and Ensuring Safety

Clinical pharmacology offers the interface between the philosophies of pharmacology and its application in the actual sense in patient care Fundamentally it is the science which examines the activities of drugs how drugs communicate with biological systems and how such communications result in treatment outcomes or adverse events Clinical pharmacology principles are needed to make sense of how m...

The Role of Technology in Drug Anti-Counterfeiting Efforts

With the rise of drug counterfeiting posing a serious threat to global public health the role of technology in anticounterfeiting efforts has become increasingly vital As counterfeit drugs continue to infiltrate the market

Why AI Is Changing What Good Validation Looks Like

The comprehensive landmark report and framework set out seven principles for using AI safely in pharmacovigilance together advocating a riskbased approach to governance validation and more Here ArisGlobals Jason Bryant highlights some of the guidances main assumptions as recently distilled in a podcast with Denny Lorenz a core member of the CIOMS XIV working group

Techno Trends

Alume Biosciences Secures FDA Breakthrough Therapy Designation for Bevonescein

Alume Biosciences has received Breakthrough Therapy Designation BTD from the US Food and Drug Administration FDA for bevonescein an investigational fluorescent drug being developed to support realtime nerve visualisation during head and neck surgery in adults Bevonescein is an intravenous fluorescent peptidedye conjugate that binds to nerve tissue

Projects

SK pharmteco Plans More Than US$200 Million Investment in Small Molecule and Peptide Manufacturing

SK pharmteco is planning a fiveyear investment of more than US million to expand and modernise its pharmaceutical development and manufacturing operations in the United States The programme will strengthen capabilities for small molecules and peptides while supporting a more

Research Insights

A drug repurposing screen reveals dopamine signaling as a candidate therapeutic pathway for PIGA-CDG

PIGACDG is a congenital disorder of glycosylation caused by pathogenic partial lossoffunction variants in the PIGA gene PIGA encodes an enzyme responsible for the catalytic transfer of Nacetylglucosamine

whitepaper

Post-Translational Modifications in Drug Discovery: From Molecular Regulation to Clinical Impact

For decades the central dogma of molecular biology has anchored our understanding of cellular function DNA to RNA to protein But this linear view is incomplete A growing body of evidence shows that much of biologys