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 vice-president addresses shifts in process and more.

Baxter International's Shaun Newlon on Manufacturing Trends

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 Role of Statistical Significance Tests

The author reviews the benefits, challenges, and considerations to be made when selecting a gamma-irradiation sterilization method.

Gamma Irradiation in the Pharmaceutical Manufacturing Environment

Blake Anson is iCell Cardiomyocyte product managerat Cellular Dynamics International, 525 Science Drive, Madison, WI 53711.

Wen Bo Wang is director of process sciences at Cellular Dynamics International, 525 Science Drive, Madison, WI 53711.

Brad Swanson is director of cell biology product development at Cellular Dynamics International, 525 Science Drive, Madison, WI 53711.

Emile Nuwaysir is COO at Cellular Dynamics International, 525 Science Drive, Madison, WI 53711.

The authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes. This article is part of a special issue on Bioprocessing and Sterile Manufacturing.

Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity Testing

Pharmaceutical Technology talked to drugmakers, equipment vendors, and service providers to learn more about the advantages and disadvantages of rapid microbial-detection methods.

An Overview of Rapid Microbial-Detection Methods

The authors describe a new microfluidic-based workflow that integrates and automates glycan cleaveage, purification, and chromatographic separation onto a microfluidic liquid chromatography–mass spectrometry chip for MS detection.

Integrated Microfluidic LC-MS

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.

The authors propose a process-centric approach for carrying out aseptic-processing and suggest further dialogue. This articles contains bonus online-exclusive material.

The Myth Called "Sterility"

Merck To Eliminate 15,000 jobs; Tauzin Stepping Down At PhRMA; And More.

Week Of Feb. 22, 2010: Company And People Notes: Merck To Eliminate 15,000 Jobs; Tauzin Stepping Down At PhRMA; And More.

Abbott Completes Acquisition Of Solvay; Merck Names President of Consumer Healthcare; And More.

Week Of Feb. 15, 2010: Company And People Notes: Abbott Completes Acquisition Of Solvay; Merck Names President Of Consumer Healthcare; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2010 edition from ABB and David Round.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes