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Quality & Compliance

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 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?

Manufacture Quality & Compliance

Getting Under the Skin of Extractables and Leachables

| Stephanie Vine

There are key benefits to having an industry standard for E&L studies – but a standard is only the beginning.

Manufacture Analytical Science

Quantum Leap in Real-time Monitoring?

| Stephanie Vine

Continuous monitoring of pharma products with an innovative matchbox-sized laser

Business & Regulation Business Practice

Studying low-affinity fragments of ligands by ITC

Dissecting a ligand into smaller fragments can provide a strategy for analyzing the role of key functional groups in a protein-ligand interaction.

Manufacture Quality & Compliance

Architects of Quality

| Sponsored by Catalent

Quality by Design: we’ve all heard the phrase – and know we should be fully on board with the philosophy. But how?

Manufacture Business Practice

Extending the boundaries of QbD

| Sponsored by Malvern Panalytical

Paul Davies and Paul Kippax from Malvern Instruments examine how a QbD approach can inform analytical instrumentation design and manufacture...

Manufacture Quality & Compliance

Mind the Gap

| Stephanie Vine

Some drug shortage prevention plans fail, while others succeed. Why? ISPE helps companies find the answer

Manufacture Clinical Trials

Characterizing Liposomes for Drug Delivery

| Sponsored by Malvern Panalytical

Researchers examine the application and usefulness of nanoparticle tracking analysis and dynamic light scattering techniques in the characterization of liposomes used as drug delivery vehicles.

Manufacture Business Practice

Beyond SOPs – Exploring the rigor and requirements of Analytical QbD

Analytical QbD (AQbD) promises to extend the rigor and benefits of QbD into the area of analytical method development.

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