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European Pharmacopoeia adopts a new chapter for the analysis of N-nitrosamine impurities
The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
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Liquid Chromatography - Mass Spectrometry (LC-MS)
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Native liquid chromatography coupled to mass spectrometric analysis for the assessment of higher order structures of proteins
The accurate measurement of the molecular mass of proteins is an essential component of protein characterisation. In this article, Ioannis Papayannopoulos discusses the applications of native protein chromatography coupled to mass spectrometry to enable the characterisation of tertiary structures and non-covalent interactions.
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European Pharmaceutical Review Issue 2 2020
This issue focuses on the regulatory challenges associated with increased ventilator demand during COVID-19, as well as articles investigating the use of LC-MS for protein characterisation, improving efficiency with continuous processing and the risks posed by cleanroom contaminants. Other features discuss the continual evolution of solid dosage forms and the…
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How is liquid chromatography used in the pharmaceutical industry?
Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
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Application note: New Peak Detection Using the SCIEX OS Software 1.5 MAM Workflow
Liquid chromatography mass spectrometry (LC-MS) is a highly accurate and sensitive platform used in biopharmaceutical research and development.
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Application note: Rapid Analysis of Genotoxic Nitrosamines by HPLC-MS/MS
Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
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Video: Automation for E&L analysis
Get a quick view of sample preparation and automation gear for E&L analysis.
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Assessing host cell protein contamination in biotechnological products
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
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IonBench: Manufacturer of mobile benches for mass spectrometry and liquid chromatography
Overview on how ionBench products can help LC/MS users with dedicated furniture for their instrumentation
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Routine mass analysis enables greater productivity in biopharma development
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
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Biopharma Processing & Development In-Depth Focus 2019
Today’s biopharmaceutical developers need accurate and precise information at all stages of research and development in order to bring safe and effective therapies to patients. This in-depth focus features novel perspectives from industry experts that serve to illustrate which technologies and systems are benefitting this cause.
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Application Note: Sensitive quantitation of the ADC ado-trastuzumab emtansine free cytotoxic drug DM1 in serum using MicroLC-MS
Antibody-drug conjugates (ADC’s) are targeted cancer therapeutics that deliver a cytotoxic agent, the payload, to the tumour.
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Application Note: Highly selective bioanalytical quantitation method for analysis of R and S amlodipine enantiomers in human plasma using LC-MS/MS
Amlodipine is an angioselective calcium channel blocker used to treat high blood pressure, chest pain and other conditions caused by coronary artery disease.
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Application Note: Simultaneous quantitation/profiling of cell culture medium components using LC-MS/MS
Multi-component methods for the detection of different compound classes, such as vitamins and amino acids, have been established and are widely used to analyse a broad range of samples.
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Application Note: Quantitation of intact therapeutic protein in plasma matrix by LC/MS
A complete workflow to quantify intact therapeutic proteins in plasma matrix has been developed, covering three critical components in preclinical sample analysis: target protein enrichment/purification, LC/MS data acquisition and quantitative data analysis.
