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

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.

Q&A: Thin-layer Chromatography Kits Screen for Counterfeits in Developing Countries

Analytical detection techniques help combat counterfeit drugs.

Chemical Confirmation

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.

Respondents to the 2011 PharmSource-Pharmaceutical Technology Outsourcing Survey paint a positive picture, but concerns linger under the surface. This article is part of a special issue on Outsourcing.

Healthy Outlook for Pharma Services

Manufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.

Outsourced Manufacturing Operations

The authors review current industry challenges and trends in managing global supply chains and propose best practices for improving visibility into those networks.

Improving Visibility of the Pharma Supply Chain: Best Practices and Technologies

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product

The pharmaceutical industry and US regulatory bodies have not responded adequately to the increasing level of outsourced manufacturing in countries such as China and India, according to a new white paper by the PEW Health Group.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes