Analytics

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.

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.

Articles

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

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

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Complex Protein Studies Demand Dynamic Techniques

Jonathon Salsbury is an associate director at PPD GMP Lab, Middleton, WI.

Jeff Driscoll is an associate group leader at PPD GMP Lab, Middleton, WI.

Greg Maj is a scientist at PPD GMP Lab, Middleton, WI.

If a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can
change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size
distribution.

The Impact of Vortexing on the Particle-Size Distribution of Pharmaceuticals

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Uniformity of Dosage Units, Part 1: Acceptance Value

Amber Lowry is an associate editor at UBM plc.

Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.

Lot Release Testing Analytics for Small-Molecule Drugs

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

FDA Expands NDMA Investigation to All ARB Class Drugs

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

Protagen Protein Services Expands Analytical Services for Biosimilar Development

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.

University of Warwick Develops New Method for Screening Polymeric Antimicrobials

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.

Analytical Method Development