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

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Articles

The American Association of Pharmaceutical Scientists (AAPS) recognized researchers at the organization's 2009 Annual Meeting and Exposition in Los Angeles this week.

AAPS Announces Annual Awards, Names 2009 Fellows

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities.

SOCMA Hails FDA Action on Citizen Petition Regarding Inspections

Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team.

Week of Nov. 2, 2009: Eli Lilly Opens Biotech Center; Johnson & Johnson Announces Restructuring; PPD Acquires Chinese CRO; More...

Angie Drakulich was editorial director of Pharmaceutical Technology.

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.

ICH Adopts Pharmacopeial Text Annexes and Prepares for Global Quality Implementation

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

Sharing Supply-Chain Security

Michelle Hoffman, editorial director of Pharmaceutical Technology.

While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.

DIY Healthcare Reform

The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products.

A Robust, Automated Karl Fischer Titration System

FDA's Edwin Rivera-Martinez on dodging supply-chain challenges.

Stay Afloat with Lessons Learned

Ranga Velagaleti is the manager of laboratory and stability at BASF Corporation, 8800 Line Ave., Shreveport, LA 71106, tel. 318.861.8040, fax 318.861.8004, velagar1@basf-corp.com

Christopher C. DeMerlis is a regulatory affairs manager at Colorcon, a division of Berwind Pharmaceutical Services, Inc., 415 Moyer Blvd., West Point, PA 19486, tel. 215.661.2766, fax 215.661.2778.

William Brock, PhD, is principal of Brock Scientific Consulting.

Robert Osterberg, PhD, is a senior consultant of pharmacology/toxicology at Aclairo PDG.

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes