Extractables in single-use systems used in ADC manufacturing

29 Jul 2024

Antibody-drug conjugates (ADCs) are biotherapeutic molecules consisting of a cytotoxin coupled to a monoclonal antibody (mAb) by a linker. Single-use (SU) systems are well suited to ADC manufacturing for several reasons, such as minimizing operator exposure to toxins. Cytiva supports the adoption of SU technologies in ADC production by extractables studies, with conditions relevant to current ADC manufacturing processes. Discover how three SU products: ReadyToProcess™ 1 L column housing, disposable ÄKTA ready™ low flow kit for chromatographic systems, and ÄKTA readyflux™ flow kit for tangential flow filtration, demonstrate low levels of extractables with organic solvents DMSO and DMA.

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LC-MSLC-MS (liquid chromatography-mass spectrometry) systems and equipment are used for separation and quantitative analysis of complex mixtures, combining liquid chromatography and mass spectrometry. Quantify proteins, contaminants, pesticides or screen for drug metabolites with a high level of sensitivity. LC-MS systems and equipment include reverse phase, normal phase and specialized columns integrated with various MS detectors such as time-of-flight (TOF), quadrupole, orbitrap or ion trap mass analyzers. LC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzer give greater sensitivity and resolving power to your analysis. Find the best LC-MS equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.GC-MS GC-MS (gas chromatography-mass spectrometry) instruments and equipment are used to separate, quantify and identify mixtures of small and volatile compounds, such as polycyclic aromatics, fatty acids and alcohols. Often used in drug detection, forensic investigation and environmental analysis for pesticides and contaminants, GC-MS is a powerful addition to your lab’s analytical capabilities. GC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzers can give greater sensitivity and resolution to your analysis. Find the best GC-MS instruments and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Compound AnalysisCompound analysis is used to discover specific compounds that could be promising candidates for pharmaceutical use. This potential is identified when compounds have the desired effect, such as interaction with a target protein, during high throughput screening.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.Low Extractable LevelsDMSODMA
Extractables in single-use systems used in ADC manufacturing