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

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

Articles

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity

Simple and affordable mass detection for the chromatographer.

Simple and affordable mass detection for the chromatographer

For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.

Ensuring Sound Bioanalytical Methods Transfer

New simulation software improves modeling for chemists and materials scientists.

Accelrys Materials Studio Enhances Modeling and Simulation

USP announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of Dec. 1, 2015.

USP Announces Revision Timeline, Effective Date for Elemental Impurities Limits and Procedures

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

The Role of NMR and Mass Spectroscopy in Glycan Analysis

Mark Wagner is purification technology and business development specialist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Jeffrey Shumway is associate director, bioavailability enhancement at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Juan Castano is process development scientist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Claire Scanlan is process development scientist at EMD Millipore, 290 Concord Road, Billerica, MA 01821.

Ruta Waghmare is group leader, process development sciences at Millipore Corporation, Billerica, MA 01821.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody Fragments

Roger Hayes of MPI Research discusses highly potent drug development.

Q&A with Roger Hayes, MPI Research

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

This article takes a statistical look at the calibration requirements for a UV spectrometer.

Calibration of instruments: Is Your UV Spectrometer Accurate Enough

Carmelo Rosa is chair of the PIC/S API Expert Circle and director, Division of International Drug Quality, US FDA.

Paula R. Katz, acting branch chief for Regulatory Policy and Collaboration, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

Alicia Mozzachio, branch chief, Division of International Drug Quality, US FDA, CDER/Office of Compliance/Office of Manufacturing and Product Quality.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes