EDITORIAL SECTION

Articles

Circular Logistics: A Strategic Advantage for U.S. Pharmaceutical Supply Chains in an Era of Uncertainty

Temperaturerelated failures are estimated to cost the industry billion annually highlighting a nonnegotiable requirement for reliability product integrity and regulatory compliance For manufacturers

Market Access Strategies for Pharma Products in Europe: A Comprehensive Guide

The European pharmaceutical market is dynamic and diverse presenting both opportunities and challenges for companies seeking market access This guide delves into effective strategies for navigating the complexities of market access in Europe focusing on key aspects such as reimbursement pricing and overcoming market entry challenges

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

Advanced Robotics and Autonomous Operations in Pharma Production

Walk the production floor of almost any modern European pharmaceutical site and you will find robots already at work Sixaxis arms denest syringe tubs Gantries load and unload lyophilisers Autonomous mobile units ferry pallets between the warehouse and the dispensary Robotics arrived in pharmaceutical manufacturing more than two decades ago and in the purely mechanical sense the argument was won lo...

Biopharmaceutical Facility Design for Sustainability: A Comprehensive Overview

The design and operation of biopharmaceutical facilities play a pivotal role in shaping the environmental impact of the pharmaceutical industry In recent years there has been a growing emphasis on sustainability within this sector

Smart Quality Management: AI-Powered GMP Compliance and Release by Exception

European pharmaceutical manufacturing has rarely faced this many simultaneous pressures Tightened sterile expectations have raised the bar across the continents fillfinish capacity biosimilar competition is compressing biologics margins and procurement authorities are pushing

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