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 author of an ambitious book about quality control falls short of reaching his goals.

A Dubious Foundation for Quality Control

The authors applied near-infrared (NIR) spectrophotometry to assess whether eight drug products were authentic or counterfeit.

Comparison of Authentic and Suspect Pharmaceuticals

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Individuals and companies at the top seem to have no problem short-circuiting their success.

Of Hubris and Happy Endings

David C. Browne is a manager of stability and pharmaceutical testing at Intertek QTI, 291 Route 22 East, Whitehouse, NJ, 08888, tel. 908.534.4445, ext. 658, fax 908.534.1054.

The author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies.

Outsourcing Stability Studies

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

The number of alliances between diagnostics companies and pharmaceutical companies is set to rise because of the growth of personalized medicine, according to a report from PricewaterhouseCoopers.

Personalized Medicine May Lead to More Mergers

Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more...

Company, People, and Regulatory Notes: Amgen and GSK Collaborate; WuXi Appoints VP of Pharmacology; More...

The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.

Final Guidance on Listing Drug-Substance Impurities in ANDAs

Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more...

Company, People, and Regulatory Briefs: Teva and Ortho Extend Agreement; Biogen Idec Cofounder Retires; More...

Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity testing provides evidence that a filter will perform correctly, has the right pore size, and has been installed correctly.

The Debate over Preuse Filter-Integrity Testing

Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more...

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes