Outsourcing

Articles

Stability testing and UPLC capabilities highlight expansion at Mumbai, India facility of SGS Life Science Services.

SGS Completes Expansion at Mumbai Facility

SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.

SGS Adds Amino Acid Analysis at German Facility

SGS has invested in additional modules for its COBAS 6000 analysis system in a move to expand its biomarker analytical capabilities at its Poitiers facility in France.

SGS Expands Biomarker Testing Capabilities at Poitiers Facility

The company has installed and validated new instruments for structural analysis of proteins.

SGS Expands West Chester Facility and Increases Protein Structural Analysis Services

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

EMA Recommends Suspension of 700 Drugs Tested at GVK Site

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

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The Challenge of Finding the Unknown

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

Validation of a Multiplex Bead-Based Assay

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Rapid Screening for Elemental Impurities using ICP-MS

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

Using Quality by Design to Develop Robust Chromatographic Methods

Changing regulations are impacting the identification and monitoring of variable materials in excipients.

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