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 discusses new detection-system technologies that can improve performance and provides key criteria to consider when selecting or upgrading a system for pharmaceutical use.

The Elements of an Effective Solid-Dosage Metal Detection Program

Several industry experts describe applications in pharmaceutical applications, including on-line total organic carbon analysis, ultra-fast liquid chromatography, rapid microbial testing, and differential scanning calorimetry-Raman Spectroscopy.

Analytical Applications

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality.

Crucial Considerations in Monitoring Process Performance and Product Quality

The author describes the development of small-angle X-ray scattering and analyzes its advantages in the characterization of drug-delivery systems and large molecules. This article is part of a special Analytical Technology issue.

Small-Angle X-ray Scattering for Pharmaceutical Applications

The authors discuss the approach taken to develop a new calibration approach, its associated protocols, and how it can be used to calculate data.

Quantitative Open-Access HPLC Analysis

The authors review and discuss the influence of glycans on the conformation of a representative IgG1 biopharmceutical using H/DX-MS as an analytical tool.

Investigating the Influence of Glycosylation on Protein Conformation and Dynamics

Novartis Sells US Enablex Rights; Ricerca Names Chemistry Director; And More.

Week of Sept. 27, 2010: Company and People Notes: Novartis Sells US Enablex Rights; Ricerca Names Chemistry Director; And More.

DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.

Week of Sept. 20, 2010: Company and People Notes: DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.

The US Food and Drug Administration recently issued a Warning Letter to Bristol-Myers Squibb (BMS, New York) for violations of current good manufacturing practice at the company's Manati, Puerto Rico, manufacturing facility.

FDA Warns Bristol-Myers Squibb about Manati Facility

Genzyme Sells Genetics Business; Bausch and Lomb Names Vice-President; and More.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes