Whitepaper: Changing regulatory environment for nitrosamine impurities
This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.
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This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.
A combination of mid-infrared spectroscopy and artificial intelligence (AI) achieved excellent prediction capability for inline pharmaceutical packaging content verification, a study has shown.
Altasciences’ Proactive Drug Development can accelerate the development of biologics by up to 40%, from lead identification to clinical POC.
NMR relaxometry is a promising technique for identifying pharmaceutical raw materials without the need for laboratory testing. Gregory Webster, Senior Principal Research Scientist at AbbVie, considers the use of NMR relaxometry for identity confirmation of monoclonal antibodies.
A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk product…
13 September 2023 | By Veolia Water Technologies & Solutions, Sievers Instruments
Learn how Rapid Microbiological Methods can provide results in less than 45 minutes and endotoxin assays can be set up in less than 10 minutes to improve contamination control and reduce risk.
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
A report has shown that growing demand for accurate identification of pharmaceutical raw materials is anticipated to boost the global Raman spectroscopy market.
Researchers have described how a process analytical technologies (PAT) fluorescent dye (FD)-based microfluidic sensor facilitated immediate feedback and control of process parameters for continuous downstream processing.
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
A study incorporating new methodologies has described a stratified sampling procedure used for analyte response evaluation in pharmaceutical migration studies.
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.