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

Topic

Articles

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

The Determination and Control of Genotoxic Impurities in APIs

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

API Purification

The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.

Sample Preparation for Quantitative Metal Impurity Testing

We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?

Finding the End of the Granulation Process

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

A firm grasp of probability and ongoing re-evaluation are key.

Reducing the Risk in Risk Management

A book about developing quality-control training manuals provides a wealth of information and a dearth of practical help.

A Quality-Control Guide Fails to Train the Trainer

The second in a series of eight case studies from the Product Quality Research Institute focuses on functional equivalence for equipment.

PQRI Case Study (2): Functional Equivalence for Equipment Replacements

This study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.

Understanding Fluidized-Bed Granulation

Thomas P. Layloff describes the advantages of using thin-layer chromatography methods for counterfeit detection. This article contains bonus online material.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes