Analytics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Effective analytics will eliminate failures, deviations, and non-conformances.

January 23, 2015

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

January 15, 2015

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

January 02, 2015

The choice of dilution schemes can minimize solution preparation errors.

December 31, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

December 15, 2014

Symbion QT chemometrics software provides Parametric Data Cleaning to handle data compromised by excessive noise or other artifacts.

November 15, 2014

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

November 15, 2014

Methods must be suitable at each development phase, robust, and effective on multiple platforms.

November 15, 2014

Analytical procedures and method validation should be developed with a structured and rigorous approach.

November 15, 2014

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

November 15, 2014

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