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

Sean Milmo is a freelance writer based in Essex, UK.

Articles

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Report from Europe

Too much or too little control can actually lead to the same result.

Everybody's Got Problems

Jeffrey D. Hofer is a senior statistician in Global Statistical Sciences at Eli Lilly and Company.

The authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.

A Risk-Management Approach to Cleaning-Assay Validation

Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

Week of May 24, 2010: Company and People Notes: Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

Week of May 17, 2010: Company and People Notes: Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

IFPMA launches Ten Principles on Counterfeit Medicines

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

Week Of May 3, 2010: Company And People Notes: FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

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 method for determining sample size is finally getting some respect.

Statistical Solutions: Bergum's Method Recognized

Michelle Hoffman, editorial director of Pharmaceutical Technology.

FDA wants industry to talk to them about the science underlying process innovations-really.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes