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

The author examines dry dispersion and outlines the related analytical method development.

Enhancing Particle-Size Measurement Using Dry Laser-Diffraction Particle-Size Analysis

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

New capillary-based imaging techniques for protein charge variant analysis are reducing development and start-up times for protein-based therapeutics.

Capillary-Based Methods Speed Protein Charge Heterogeneity Determination

Increasing production efficiency while ensuring high parenteral product quality is the goal of both manual and automated visual inspection systems.

Improving Performance Through Visual Inspection

Shimadzu's LCMS-8040 combines newly improved ion optics and collision cell technology with proprietary ultrafast technologies.

The world's fastest LCMS/MS tandem mass spectrometer

The process-driven system reduces total cost of ownership.

Accelrys Adds Laboratory Information Management System to Software Suite

Iterative and multiple incremental advances in particle-characterization technology are making a difference in pharmaceutical analysis applications.

Particle Characterization is Critical for Drug Performance

Thomas A. Little is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.

Method Validation by Design to Support Formulation Development

The mysteries of rounding are exposed; strict, unbiased rounding can be applied.

Rounding Results for Comparison with Specification

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Bristol-Myers Squibb embarks on a multi-year journey to overcome the challenges of serialization and reap the benefits.

Preparing for Serialization

Thermo Fisher Scientific Inc. launched new software, instruments, consumables, and services for analytical applications at Pittcon 2013.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes