EDITORIAL SECTION

Articles

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...

Enhancing Drug Quality and Efficiency with Smart Manufacturing

Smart manufacturing development leads the pharmaceutical industry toward a substantial industrial shift Current regulatory oversight has created production cost challenges that manufacturers face while managing drug safety requirements for highquality medicine production What are the methods by which technology can change the production methods of drugs What position does automation and artificial...

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...

The Role of European Pharma in Global Healthcare Advancements

Europe is one of the largest players in the international market for health care due to research development and innovation and competitive pharmaceutical industries Some of these European pharma medical research organizations and health care systems have continually provided valuable solutions to the welfare of people globally It is an increasingly important role for them to play given that they...

The Competitive Generic Therapy (CGT)

Generic medications are critical in the healthcare sector due to their affordability and accessibility to the public while maintaining comparable quality efficacy and safety to that of branded products Generic medications research and development followed by commercialisation also fosters competition and innovation within the pharmaceutical

Fostering Pharma Collaboration: Challenges & Opportunities

In the everevolving world of pharmaceuticals fostering collaboration is essential for driving innovation and meeting the diverse needs of patients However this seemingly simple goal is often hindered by numerous challenges

Techno Trends

UGA researchers develop oral drug candidate targeting drug-resistant malaria

Researchers from the University of Georgia UGA and the University of Illinois Chicago have developed a new oral antimalarial drug candidate that could help address drugresistant malaria

Projects

Evonik Launches US$94 Million (EUR 80 million) Biotechnology Expansion in Slovakia

Evonik has commenced construction of a new biotechnology expansion at its Fermas facility in Slovensk upa Slovakia The development is part of an approximately US million investment EUR million

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