New mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
30 October 2024 | By Charles River
Webinar presented by Miriam Guest, Senior Principal Scientific Advisor at Charles River, to explore how ATP-bioluminescence outperforms traditional sterility testing in complex matrices.
The nonIP-RP-LC-MS method provides an “easy, reliable, and cost-effective” approach for bioanalysing oligonucleotide therapies.
The versatility of liquid chromatography is propelling demand for high-quality chromatography reagents, the report stated.
Peak tracking in liquid chromatography (LC) method development can be challenging due to retention variations and co-elution. LabSolutions MD software with LCMS-2050 SQ-MS simplifies peak identification and automates method and sequence creation, enabling efficient development of reliable separation methods.
Specialised microbial testing is key in drug development to mitigate contamination risks, which threaten drug efficacy and patient safety. Bruker's MALDI Biotyper® at MPL, Austria, ensures accurate and robust testing, in a high-throughput workflow, delivering reproducible results.
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
A study investigating levothyroxine has reported a new non-targeted analytical approach for pharmaceutical quality control analysis.
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and…
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
The widely used continuous chromatography technique, simulated moving bed (SMB) chromatography, developed to the micro-scale as a process analytical technology (PAT) application, has been shown to greatly increase mass spectrometry sensitivity.
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…
A paper has depicted extractive-liquid sampling electron ionisation-mass spectrometry (E-LEI-MS) as a new real-time MS technique for direct analysis.