Analytics

Articles

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L. 

Considerations for Analytical Testing for E&L

Feliza Mirasol is the science editor for 

Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.

Invitae and Deerfield Management Team Up on Novel Therapeutics for Rare Diseases

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

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.

Never Mind the Statistics; Just Tell Me What the Answer Is! 

Paul Van Tilborg is director of analytical sciences at Ardena.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Phase-appropriate Analytical Methodology

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Amanda Guiraldelli Mahr is scientific affairs manager, US Pharmacopeia.

Joachim Ermer is head of Analytical Lifecycle Management Chemistry Frankfurt at Sanofi.

Stephanie Sproule is a member. of the USP M&DQ EC.

Jean-Marc Roussel is a  member of the USP M&DQ EC.

Jaime Marach is member of USP Analytical Procedure Life Cycle Joint Subcommittee.

Horacio Pappa is senior director, US Pharmacopeia.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Shiri Hechter is senior lab operations manager for Nelson Laboratories

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

Considerations for Method Validation

As the development of increasingly complex biologics grows, more robust bioassays are required to accurately characterize these molecules.

Robust Bioassays Needed for Increasingly Complex Analytical Workflows

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Analytical techniques for validating cleaning methods must evolve to match the pace of an increasingly complex manufacturing landscape for new therapeutics.

Validating Cleaning Methods in Bio/Pharma Processes

The launch of Discovery Life Sciences’ new Proteomic Services Division offers a single source for large-scale population studies, biobank characterization, and multi-omic biomarker analysis.

Discovery Life Sciences Now Offers Large-Scale Proteomic Services

Wai-Chi Man is IC/SP product marketing manager at Thermo Fisher Scientific.

One can improve method precision and productivity by replacing one step in sample preparation with an automated approach.



Analytical Method Development