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

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Articles

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

Regulation of Aseptic Processing in the 21st Century

Warner Chilcott announced in a press release on Apr. 18, 2011, its intentions restructure, placing 500 Western European jobs on the line.

Warner Chilcott to Axe 500 European Jobs

Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

Week of Apr. 21, 2011: Company Notes: Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

The implementation of digital photomicrography has expanded the capabilities of microanalysis for quality control. But if used incorrectly, the technique can hurt more than help.

Best Practices for Digital Photomicrography of Pharmaceutical Contaminants

To find out how well industry is applying QbD, and what benefits the approach can bring, Equipment and Processing Report talked to Moheb M. Nasr, director of FDA?s Office of New Drug Quality Assessment.

Are Drugmakers Using Yesterday's Quality Strategies?

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

FDA Publishes Guidance for Preventing Cross-Contamination

Editor's picks of analytical instrumentation products for April 2011.

In the Spotlight April 2011

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.

The hardest errors to spot are the ones that don't look like errors at all.

Pitfalls in Statistics

Victoria Jones, Laboratory Manager, Physical Science Laboratory, RSSL.

Particle characteristics can affect pharmaceutical formulations and products in a number of ways, and a variety of techniques are available that enable particle monitoring and characterisation.

Challenges Of Particle Characterisation

Many facilities buy compressed gas tanks or evaporate liquid nitrogen to supply processes with dry, high-purity nitrogen. An in-house nitrogen generator, however, provides several significant benefits.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes