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

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Articles

Shimadzu’s Nexera Method Scouting system provides an outstanding platform for efficient HPLC method development and implementation. It is based on the Nexera X2 next-generation ultra-high performance liquid chromatograph, an all-round LC system for ultra-high-speed analysis.

Universal solution for automated HPLC method development

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

Ligand-binding assays are fundamental to characterizing biosimilars.

Ligand-Binding Assays and the Determination of Biosimilarity

Shimadzu, one of the world leaders in analytical instrumentation, has introduced the i-series of integrated HPLC and UHPLC systems.

i-series - the new driver of i-volution in HPLC analysis

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

EMA Sets Elemental Impurities Implementation Dates

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

USP Elemental Impurities Implementation Set for January 2018

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

The choice of dilution schemes can minimize solution preparation errors.

How Accurate are Your Dilutions?

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

Chinese API and Drug Manufacturer Issued Warning Letter

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

Chemometrics Software Handles Noise and Artifacts

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

The Challenge of Finding the Unknown

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

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes