EDITORIAL SECTION

Articles

What Are the Benefits of Implementing a Modern MES in Pharma?

The pharmaceutical sector is rapidly changing in a bid to match the increasing pressure of regulation attain perfection in product quality and hasten the timetomarket A Pharma MES or Manufacturing Execution System is one of the most strategic investments that are strategically placed in this environment in terms of operational excellence

Breaking Down Barriers: Advancements in Biodegradable Drug Delivery

In todays world where sustainability is a top priority breaking down barriers to a greener future is crucial One area where advancements are being made is in the field of biodegradable drug delivery

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...

From Visibility to Decision Readiness: The Next Phase of Quality Maturity in Pharma

Over the past decade pharmaceutical organisations have made strong progress in both digitising and digitalising quality operations Systems such as laboratory information management systems LIMS manufacturing execution systems MES and electronic quality management systems eQMS have strengthened traceability embedded workflows and enabled real time visibility across quality processes

Why Biopharma is switching to Single-Use Systems: Cost, Quality, and Flexibility

Singleuse biopharma systems have replaced traditional stainlesssteel systems in the biopharmaceutical industry because of a major industry transformation What factors lead the market toward this direction Major factors that drive the industry involve establishing savings from singleuse equipment in pharmaceutical applications

Advancing Pharmacovigilance Talent for AI: Overcoming Skills and Resource Barriers

In the transforming field of pharmacovigilance PV artificial intelligence AI is reshaping how drug safety is monitored and managed As PV evolves from manual reactive workflows to sophisticated AIaugmented systems the imperative for comprehensive workforce upskilling grows stronger Organisations and professionals must adapt to new technical demands regulatory requirements and ethical challenges to...

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

One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases

Idarubicine is a mainstay of the treatment strategy for hematological cancer The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies

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