EDITORIAL SECTION

Articles

Manufacturing mRNA, Cell, and Gene Therapies at Commercial Scale

Why Cell and Gene Therapies Fail in Europe After the Science Has Already Worked The uncomfortable statistic for anyone financing advanced therapies in Europe is not the clinical attrition rate It is the withdrawal rate after approval An analysis of advanced therapy medicinal products granted European marketing authorisation found that roughly one in five had subsequently been withdrawn and of th...

Achieving Full Digital Maturity in Pharma Manufacturing: A Paperless Transformation Guide

The pharmaceutical sector is changing radically as manufacturers do not rely on the past and dataintensive processes The vision of paperless pharma manufacturing is not a dream anymore it is a strategy based on the pressure of the regulators the complexity of operations and the need to accomplish faster and with accuracy production The center of this change is the digital pharma manufacturing and...

Advancing Pharmaceutical Manufacturing with Robotics and Automation

The pharmaceutical sector is experiencing one of the most fundamental changes ever in its history triggered by the booming growth of robotics intelligent automation and AIdriven manufacturing systems Developing new and improved drugs and with increased demands on the globe the old processes based on manual labor and fragmentation are no longer able to produce drugs as quickly precisely and in larg...

From Lab to Market: The Journey of a New Drug

The process of synthesizing a new drug takes many years and several phases and all of them are important for the drug safety and efficacy Which from the first identification in a lab to the final approval of use by the public is a process that takes over years and this involves work done by scientists various agencies and other health care givers

mRNA and Oligonucleotide Therapeutics: Emerging Synergies in Genetic Medicine

MRNA therapies work by introducing synthetic mRNA encoding a therapeutic protein enabling transient protein expression that can replace deficient enzymes stimulate immune responses or facilitate gene editing This additive approach is beneficial for diseases caused by lossoffunction mutations or when temporary protein expression is desired

Global CDMO Expansion: Supporting the Growing Advanced Therapy Pipeline

The European advanced therapy sector has spent the better part of two decades proving a scientific point that engineered cells corrected genes and reprogrammed immune systems can deliver durable clinical benefit That argument is now largely settled The question facing pharmaceutical and biotech leadership is industrial rather than scientific whether these therapies can be manufactured consistentl...

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