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

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product.

Analytical Applications

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

Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation.

Using a Systematic Approach to Select Critical Process Parameters

F.C. Girard, PhD, is CEO of Spinnovation Analytical.

The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.

Nuclear Magnetic Resonance as a Bioprocessing QbD Application

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2012 edition from UFP Technologies and Mettler Toledo.

October 2012 Editor's Picks: Products from UFP Technologies and Mettler Toledo

Managing risk in biopharmaceutical operations is of utmost importance for patient protection.

Integration of Less-Formal Risk Assessment Tools into Change Control

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.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes