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With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
Leakage, cracking and corrosion in pressure vessels present a serious risk for operators of pharmaceutical production systems. Imminent damage must be reliably identified at an early stage to enable necessary steps to be promptly taken. Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, explains how TÜV SÜD…
Discover why Merck’s new MAS-100 Atmos® compressed gas sampler should be your go to for detecting microbial contamination…
Disulphide bonds between cysteines play a critical role in the stability and activity of therapeutic antibodies. Here, Dr Ioannis Papayannopoulos, Principal Scientist at Dragonfly Therapeutics, describes the characterisation of the oxidation state of cysteines and formed disulphides in therapeutic antibody drugs.
Ayman AlSaadi and Wayne G Carter from the School of Medicine, University of Nottingham, illustrate the value of analysing the wastewater of specific populations to gain insight into levels of illegal drug usage and other health-related biomarkers.
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, discusses the benefits of leveraging acoustic emission testing to identify faults in compressed air pressure vessels, and Associates of Cape Cod and SGS Health Science showcase their services,…
In this in-depth focus, articles illustrate how mass spectrometry‑based wastewater analysis can estimate illicit drug usage and explore the applications of mass spectrometry in characterising therapeutic antibodies.
Water content determination of Ibuprofen tablets with an automated Karl Fischer titrator coupling with gas phase extraction.
In this article, pharmaceutical microbiologist and contamination control expert Tim Sandle presents three microbial contamination investigation case studies, highlighting the key lessons for pharmaceutical microbiologists to take away and the underlying importance of identifying the root cause of microbial data deviations.
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.
The examples of common applications in the pharmaceutical industry for titration, UV/VIS spectroscopy and physical values are presented in details.
25 March 2022 | By SCIEX
Exploring the complexities of nitrosamines to enhance understanding and overall management, with a focus on nitrosamine drug substance-related impurities (NDSRIs).
A study shows terahertz light creates twisting vibrations in biomolecules, enabling the analysis of their compositions and structures.
