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

New European Pharmacopoeia chapter aims to resolve problems with applying the harmonized UDU test to large sample sizes.

Uniformity of Dosage Units Using Large Sample Sizes

The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

Quality by Design for Analytical Methods: Implications for Method Validation and Transfer

Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications.

Determining Potency of Preclinical Dose Formulations

Real-time experimentation may offer continuous process improvement.

Tools in Waiting: Time for Evolutionary Operation

New product reviews for October 2012, featuring analytical equipment.

In the Spotlight October 2012

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.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes