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

Articles

The Steritest NEO device from MilliporeSigma provides safer pharmaceutical product testing through additional features.

Enhanced Sterility Testing Device

Yasvanth Ashokraj works in Integrated Product Development at CIPLA.

Prashant Modak works in Integrated Product Development at CIPLA.

Kalpesh Sawant work in Integrated Product Development at CIPLA.

Praveen Date works in Integrated Product Development at CIPLA.

Swati Laud works in Integrated Product Development at CIPLA.

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

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

Early adoption of the right approach to address solubility can deliver significant benefits.

The Solubility Conundrum

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.

Apprehension Shapes Employee Satisfaction

Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.

Integration of two separate chromatography data systems boosts workflow efficiency.

The Benefits of an Advanced Chromatography Data System

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

Microbial identity data can be critical for determining contamination sources.

Microbial Identification Strategies for Bioburden Control

Melissa Hanna-Brown is external technology & collaborations lead at Pfizer.

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

Stephanie Katzenbach is senior scientist, New Biological Entities, Analytical R&D at AbbVie.

Andy Rignall is product technical director at AstraZeneca.

Annick Gervais is director, Analytical Sciences Biologicals at UCB.

JÃ¶rg Hoffmann is director, CMC Regulatory Compliance at Merck KGaA.

Jette Wypych is director, Attribute Sciences at Amgen.

Kieran McLaughlin is principal scientist at MSD.

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.

Oliver Grosche is director, Collaborative Solutions at Elanco.

Peter Hamilton is scientific leader at GSK.

Thomas Uhlich is laboratory head Analytical Development at Bayer.

Christof Finkler is Analytics Biochemistry site head at Roche.

Katrin Liebelt is analytical project leader at Novartis.

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.


Analytical Procedure Lifecycle Management: Current Status and Opportunities

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.


Three Examples of Hypothetical ATPs

A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.

High-Throughput Microplate Reader Cuts Down Screening Time

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.