INDUSTRY PERSPECTIVE

Phase-Appropriate Formulation and Process Design

Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.
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SERIALIZATION

Serialization: Getting Past the Quick Fix

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.
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PEER-REVIEWED RESEARCH

Cleaning Limits—Why the 10-ppm Criterion should be Abandoned

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
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EUROPEAN REGULATORY WATCH

A Call for Radical Reformation of the World Health Organization

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.
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API SYNTHESIS & MANUFACTURING

Nanotechnology Shows Promise for API Synthesis and Delivery

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.
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PACKAGING FORUM

Parenteral Packaging: 2021

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.
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TROUBLESHOOTING

Using Deterministic Container Closure Integrity Testing

The revised USP Chapter <1207> Sterile Product Packaging—Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods.
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ASK THE EXPERT

Managing Market Expansion’s Effect on Procedures

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
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Webcasts

Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by Patheon

Strategies to Accelerate Early Phase Clinical Trials

On Demand
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by SGS