EDITORIAL SECTION

Articles

Efficiency in Bioprocessing: Unveiling Upstream and Downstream Operations

Bioprocessing plays a crucial role in the pharmaceutical biotechnology and healthcare industries ensuring the efficient production of biologics vaccines and other biobased products

Clinical Trials: Failures and Challenges on the Path to Treating Alzheimer’s

Alzheimers disease AD is a neurodegenerative disorder with symptoms of memory loss and cognitive disability Typically it begins with mild symptoms that progress to become more severe AD is the th leading cause of death in the United States among people or older In million Americans suffered from AD and this is expected to rise to million by

How to Mitigate Operational Risks in the Pharma Industry?

The operation of the pharmaceutical industry has significant risks with the most probable being operational risks These risks include supply chain interruption regulatory non compliance product defects technological disruption The development of strategies to avoid compromise in operations remains paramount not only in protecting the customers from harm or receiving

Real-World Evidence in Pharmaceutical Drug Development

For most of the past halfcentury the randomised controlled trial has been the undisputed gatekeeper of pharmaceutical value It remains the gold standard for establishing causality and nothing in this article suggests otherwise Yet the controlled trial answers a narrow question under artificial conditions does a drug work in a carefully selected population managed by expert investigators over a fix...

Access to Affordable Medicines: A Persistent Challenge for Europe

The problem of affordable medicines has been topical in Europe for many years Despite the fact that there are well developed health units in many regions of the world and particularly in this continent the health challenges of the population have not been fully met especially in access to affordable basic medicines This problem is relevant not only to the patients but also to the stability of heal...

From Static PDFs to Usable Digital Forms in Pharmaceutical Operations

Walk through the quality compliance or operations function of almost any pharmaceutical manufacturer and youll find PDF forms everywhere from deviation reports change controls and training records to supplier questionnaires audit checklists and equipment logs Many of these documents exist as PDF files but functionally still behave like paper Someone prints them fills them in by hand

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