EDITORIAL SECTION

Articles

Digital Bioprocessing: AI and Automation in Biologics Manufacturing

For most of the modern biologics era a mammalian cell culture batch was managed the way a ship is navigated in fog a fixed course periodic position checks and very little ability to correct midvoyage Operators set a feed strategy pulled offline samples once or twice a day and waited for the analytics to say whether the batch had drifted By the time a titre shortfall or a glycosylation shift appear...

Cybersecurity in Pharma: The Threat No One Budgeted For

There is a particular kind of risk that organisations are bad at pricing the one that has never happened to them Pharmaceutical companies have spent a generation building sophisticated defences against the risks they know intimatelycontamination adulteration deviation recall Quality systems are mature inspectionready and deeply funded Cyber risk has never enjoyed that status It sat in the IT budge...

How Digitalization Improves Pharma Manufacturing and Compliance

The pharmaceutical industry has been at a crossroads where the digitalization process is transforming the way drugs are developed manufactured and monitored Pharmaceutical companies are capitalizing on the power of digitalization in pharmaceutical production to maximize production improve traceability and regulatory compliance due to the tough regulatory requirements and the demand for absolute pr...

The Rise of Personalized Medicine in Europe: Opportunities and Challenges for Pharma Companies

In Europe there is a growing momentum around personalized medicine an inventive method that customizes medical treatments based on individual characteristics As progress in genomics and molecular diagnostics advances

How to Optimize Batch Production in European Pharmaceutical Manufacturing?

Efficient and highquality batch production is crucial for success in the European pharmaceutical industry This short introduction explores key strategies for optimizing manufacturing processes

The Next Growth Strategy: Scaling GLP-1 Manufacturing and Global Market Expansion

For most of the past four years the strategic conversation around GLP receptor agonists was a demand story Prescriptions outran forecasts waiting lists formed pharmacy shelves emptied and the commercial debate centred on reimbursement prescriber behaviour and how far the obesity indication could stretch That conversation has changed Demand for incretin therapies is now the most predictable variabl...

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