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

International trade can be great for business, but breaking border laws can put one in hot water.

Compliant or Contraband?

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

Process Analytical Technology: Charting Progress in Data Analysis

MIT survey results address product and site characteristics that statistically correlate with quality performance.

Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product Deviations

The authors describe a QbD study that was performed to optimize a coating system.

Achieving Process Understanding and Control in Film Coating

In the Spotlight August 2012

The author discusses how to manage pending pharmacopeial changes.

Elemental Impurity Analysis

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

A Statistical Review of ICH Q10 Pharmaceutical Quality System

Meticulous system configuration can prevent machines from taking over.

Technology Fights Back

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.

GMPs for Method Validation in Early Development: An Industry Perspective (Part II)

Robert Clifford is industrial business manager at Shimadzu Scientific Instruments. rhclifford@shimadzu.com

Minako Tanaka is a scientist at Shimadzu Applications Development Center, Kyoto, Japan, minako@shimadzu.com

Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes