whitepaper
Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
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Formulation
article
Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
whitepaper
Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
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Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
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Technical note: The content of nevirapine and related impurities
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
whitepaper
Whitepaper: USP method modernisation
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
whitepaper
Application note: Impurity analysis of L-aspartic acid and glycine
Simultaneous detection of amino acids and organic acids by a single method, therefore reducing analysis time and costs.
video
On-demand webinar: AstraZeneca’s fully automated nitrosamine analysis
This on-demand webinar details a qualified automated approach to nitrosamine testing in products, which simultaneously prepares samples for LC-MS and GC-MS.
whitepaper
Whitepaper: Accelerate biologics development via innovation
This whitepaper provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.
whitepaper
Case study: Amino acid analysis for EP compliance
An ion chromatography solution, devoted to fast turnaround of raw material testing for amino acids per the EP monographs.
whitepaper
Press release: Freeze drying: New Telstar Usifroid platform for retrofitting & maintenance
Telstar launches Usifroid global service platform for retrofitting & maintenance of freeze-dryers. To optimise and extend the life cycle of freeze-drying equipment from any brand or model.
whitepaper
Whitepaper: Drug repurposing strategies to shorten timelines
This whitepaper explores drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications.
article
What to consider when formulating bacteriophages
In this article, Dr Michael Koeris, Associate Professor, Bioprocessing at Keck Graduate Institute, and Carolina Moraes de Souza, Keck MEng graduate, now Process Development Senior Associate at Amgen, discuss the key formulation considerations for bacteriophages, a potential solution to antimicrobial resistance, and why process development should be an early consideration.
whitepaper
Application note: Impurity analysis of gabapentin by HPLC-UV-CAD
This application aims to replace the two separate compendial methods for the impurity analysis of gabapentin with one single HPLC method.
whitepaper
Application note: Scale Up Assist can help antibody workflow
This study details the use of the new Scale Up Assist feature of the BioFlo 720 Bioreactor Control System to scale CHO batch cultures.
