Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
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Liquid Chromatography - Mass Spectrometry (LC-MS)
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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.
Overview on how ionBench products can help LC/MS users with dedicated furniture for their instrumentation
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.
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.
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.
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.
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.
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.
The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…
The rapid increase in demand for biopharmaceuticals presents manufacturers with unique challenges to ensure quality and regulatory compliance while maintaining supply and production capacity.
The purpose of process development in pharma is to select and optimise a synthetic route to produce the active pharmaceutical ingredient (API) by the safest, cheapest, fastest, and cleanest (by green chemistry where possible) route, following both Good Laboratory Practice (GLP) and Quality by Design (QbD) principles.
Scientific Poster: How complementary chromatographic methods can support a full analytical picture in pharmaceutical drug development
HPLC is a rapid, accurate and sensitive method for determination of pharmaceutical drugs, degradations and impurity profiling. It is a preferred method for analytical characterisation during drug development.