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

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Articles

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.

Using the Guard Band to Determine a Risk-Based Specification

Transcat's Cost, Control, and Compliance (C3) software platform is designed to improve asset tracking and process management for metrology instrumentation.

Customizable Software Tracks Metrology Requirements

Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.

Investigation of Various Impurities in Febuxostat

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

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

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

Taking Action on Elemental Impurities

Joanne Ratcliff, PhD, is communications project manager, Laboratory Weighing, Mettler Toledo GmbH, Joanne.Ratcliff@mt.com.

Martin Huber, PhD, is head of the GWP competence center at Mettler Toledo, Martin.Huber@mt.com

The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.

Complying with Revised Weighing Guidelines

Developments in chromatography column technology to deliver greater efficiency, speed and inertness benefit the drug development process from discovery to manufacturing and quality control.

Innovations and Future Trends in HPLC Column Technology

Paul Kippax is a product manager, Laser Diffraction, Malvern Instruments Ltd., Enigma Business Park, Grovewood Road, Malvern Worcestershire, UK WR14 1XZ, Paul.Kippax@malvern.co.uk.

Paul Davies is global business manager for Malvern Instruments.

A diverse range of particle sizing solutions is available, from techniques for the characterization of complex formulations through to online PAT tools for real-time measurement.

Advances in the Pharmaceutical Industry Have Shaped Particle Sizing Technology

Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.

Contractors Invest in Capacity and Capabilities

Experts from contract testing laboratories and service organizations shared their perceptions of analytical testing advances, and challenges still ahead.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes