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

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Articles

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.

NIBRT, Valitacell Aim to Validate New Analytical Technology

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Industry–academia collaborations seek to address unmet needs in measurement science.

Precompetitive Research Spurs Innovation in Pharmaceutical Analysis

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

Analytical Best Practices for Raw Materials Testing

Agnes Shanley is senior editor of Pharmaceutical Technology.

By reducing the number of assays needed and allowing product quality attributes to be measured end to end, MAM promises to allow users to gain product and process understanding much sooner than they could in the past, and to ensure quality and safety in a more efficient, streamlined way, throughout the product life cycle.