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Business & Regulation Business Practice

The Problem of Counting Counterfeits

| Stephanie Vine

Recently, Tim Mackey and colleagues examined the extent to which counterfeit drugs had penetrated global legitimate supply chains.

Manufacture Business Practice

Characterization of IgG monomers & their aggregates

| Sponsored by Malvern Panalytical

Two antibody samples were characterized using column calibration and multi-detection SEC, and the results compared...

Manufacture Business Practice

Utilization of kinITC in AFFINImeter

| Sponsored by Malvern Panalytical

This application note describes how and when can kinetic information be retrieved from ITC power curves.

Manufacture Bioprocessing - Single Use Systems

Disposing of the Past and Embracing Single-Use Technology

| Stephanie Vine

Single-use technology is ready to lend a helping hand to biomanufacturing, but is the industry ready to turn away from stainless steel?

Manufacture Standards & Regulation

When Fakes Attack!

| Mark Davison

Regulators are driving serialization and tamper-evident packaging initiatives, but is the pharma industry fully primed to defend against counterfeits?

Manufacture Bioprocessing - Single Use Systems

Bringing Vaccines into the 21st Century

| Sponsored by GE Healthcare

Lawrence (Larry) Lesko is a bioanalytical veteran with many years of academic and FDA experience under his belt.

Manufacture Facilities

Embracing Rapid Microbiology

| Tim Sandle

Microbiological approaches are faster and more advanced than ever before – so why on earth isn’t the pharma industry using them?

Manufacture Quality & Compliance

Painting a Better Picture of Quality

| Christian Mänder, Thomas Friedli

When seeking to measure quality across an organization, what is the right approach?

Discovery & Development Clinical Trials

Cancer Complexity

| James Ritchie

Clinical development is outmoded; we are witnessing serious attrition in cancer R&D. Perhaps it’s time to live and die by the mantra: “no biomarker, no trial”.

Business & Regulation Standards & Regulation

All Change at the Top

| Stephanie Vine

The EMA fights to reinstate its former executive director – and the FDA’s new leader is still unconfirmed

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