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

From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy

Every pharmaceutical executive can recite the journey from molecule to market Far fewer can say with confidence at which point in that journey their manufacturing strategy became capable of withstanding a regulatory inspection The distinction matters more than it once did Approval timelines are compressing

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

Decision Integrity: The Layer ALCOA+ Was Never Built to Cover

When a model helps make a GxP call the data underneath it can be spotless and the decision still indefensible Here is where the gap opens and the controls that close it For years the discipline that has kept regulated records trustworthy is data integrity We learned ALCOA then ALCOA and built whole quality systems around the idea that a record has to be attributable legible contemporaneous origin...

Gene Therapy: Breakthrough Treatments for Rare Diseases

The idea of gene therapy is radically changing the sphere of medicine with the possibilities to cure the patients with the rare hereditary diseases These diseases which are usually brought about by the alteration of the sequence

Genetic Testing in Mainstream Medicine: Driving Precision, Prevention, and Population Health

Healthcare systems globally are shifting toward valuebased care where reimbursement is tied to outcomes not procedures Genetic testingparticularly multigene panels and polygenic risk scores is emerging as a highimpact enabler of early intervention and targeted prevention reducing longterm costs and improving clinical outcomes

Techno Trends

University of Dundee’s Cabamiquine Shows Promise for Single-Dose Malaria Treatment

Researchers at the University of Dundee have reported encouraging clinical results for cabamiquine a novel antimalarial compound being developed as a potential singledose treatment for malaria

Projects

Genentech to Invest US$750 Million in Oregon Device Fill-Finish Facility

Genentech a member of the Roche Group plans to invest approximately US million in a new device fillfinish manufacturing facility at its acre campus in Hillsboro Oregon The project will add endtoend manufacturing

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