EDITORIAL SECTION

Articles

Considerations and Functional Elements of Closed Systems: Isolators and Single Use Systems

Advances in technology have demonstrated the feasibility of using isolators and singleuse systems SUS in routine pharmaceutical manufacturing operations particularly in aseptic processing Their implementation has significantly reduced the risk of chemical particulate and microbiological contamination

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

Building Resilient Pharma Supply Chains to Strengthen Patient Care

The failure to deliver a temperaturesensitive biologic or a critical maintenance drug on time is becoming a patient outcome crisis not just an operational inefficiency By fortifying our global logistics networks we proactively safeguard the availability of lifesaving therapies and essential healthcare supplies securing the healthcare industrys central promise to global health This strategic impera...

Implementing Quality by Design (QbD) in Pharmaceutical Development: Enhancing Product Quality and Regulatory Compliance

Quality by Design QbD stands as a systematic strategy for pharmaceutical development prioritizing predefined product objectives and emphasizing a thorough understanding of both the product and its manufacturing processes This proactive approach integrates quality seamlessly into the development process championing a sciencedriven

Ritonavir: How the Discovery of a New Polymorph Changed Drug Development Forever

AIDS is a chronic illness that gained global attention in the s It weakens the immune system of the body making it hard to fight infections When HIV enters the body it targets CD Tcells a type of white blood cell that helps defend against diseases It uses the machinery of Tcells to make new copies of the virus due to which the immune cells are destroyed As the virus spreads and the number of healt...

COVID-19 Vaccines & SARS-CoV-2 Variants: Who is winning the Race?

It was not uncommon to name the year as annus horribilis as the SARSCoV quickly spread all over the globe causing the first pandemic in years leading to devastating consequences on health economy and the society in general Neither drugs nor vaccines were available for more or less the whole first year of the pandemic causing devastation helplessness and uncertainty Since the beginning of the COV...

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