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

Current methods for establishing visible residue limits (VRLs) are not statistically justifiable. The author proposes a method for estimating VRLs based on logistic regression.

Statistically Justifiable Visible Residue Limits

To best carry out the vision of Hatch-Waxman, Congress must act now on biogenerics.

Consumers Need Access to Lower-Cost Biogenerics

Brief pharmaceutical news items for March 2010.

Pharma Capsules

From last-minute product inserts to putting out fires, close calls are a common occurrence.

Quick Saves and Near Misses

Michelle Hoffman, editorial director of Pharmaceutical Technology.

If both sides of the aisle don't agree on even mild healthcare reform soon, the bill could die out.

Skinny or Dead

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.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes