There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

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Articles

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Quality Issues for Multiregional Clinical-Trial Materials

The authors summarize a recent FDA–PQRI workshop on process drift.

FDA/Industry Perspectives: Detection, Measurement, and Control in Manufacturing

Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.

OOS, OOT, OOC, and OOSC

New product reviews for October 2011 focusing on analytical instrumentation.

In the Spotlight October 2011

The authors summarize the Matrixx Initiatives, Inc. v. Siracusano case's implications for industry.

The Matrixx Zicam Verdict

This risk-management case study focuses on assessing empty capsules.

PQRI Case Study (4): Process Deviation and Empty Product Capsules

GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company's cancer-diagnostic and molecular-imaging capabilities, as well.

GE Healthcare to Invest $1 Billion in Oncology

Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.

Testing for Glass Flakes in Pharmaceutical Vials

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

ISPE to Publish Updated Sterile-Product Manufacturing Guide

Powder Systems Ltd's (PSL's) new GFD&#153; isolator combines the latest innovation to provide a high containment lab scale filtration and drying solution with the same reliability and benefits as PSL high containment production size filter dryers.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes