EDITORIAL SECTION

Articles

Quality by Design Is a Mindset, Not a Milestone

Every medicine is a promise about consistency The tablet dispensed in Milan next spring must behave exactly like the one tested in a trial four years earlier and like the ten million made between them

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...

How Quantum Computing Is Transforming Drug Discovery

The current medical setting sees technology lead drug development towards faster speeds Quantum computing in drug discovery belongs to an exclusive group of technological advances that drives revolutionary change in science The advanced computational model called quantum computing drives innovation in drug discovery as well as drug testing and pharmaceutical market release Scientists and experts n...

Pharma ABM Strategies for B2B Growth: Precision Targeting for Key Accounts

The pharmaceutical industry is making significant strides changing the way that company ies are identified engaged and converted into high value business customers In todays datadriven competitive world traditional mass marketing strategies are no longer effective In todays day and age pharmaceutical companies are embracing very personalized relationships ROI measurement and the expansion of their...

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

Pharmaceutical Market Access and Reimbursement Strategies in Europe

Getting EMA approval is a milestone but it isnt a launch In Europe a medicine can be authorized in every member state and still not reach a single patient until each country agrees on its price and who pays for it That gap between approval and access is where pharmaceutical market access is won or lost

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