Cygnus Technologies’ Protein L Mix-N-Go™ ELISA Kits enable fast and accurate assessments of residual Protein L remaining in your antibody fragment drug products.
Purification of antibody fragment drug substances (such as Fab, scFv, or single domain antibodies containing a kappa light chain) is typically achieved via Protein L affinity chromatography, since these fragments generally lack the capability to bind Protein A. To comply with regulatory guidelines, detection and quantification of Protein L ligand post-purification is required to ensure minimal protein L is present in the eluted drug substance. As leached Protein L is often in a complex with the antibody fragment, the samples must be subjected to a dissociation step to ensure accuracy of quantification.
Cygnus Technologies’ Protein L Mix-N-Go™ assay incorporates a revolutionary single-step sample treatment to irreversibly dissociate Protein L from the antibody fragment drug product without the need for sample boiling and centrifugation, reducing the complexity of the assay, required equipment, and time to result, while increasing the robustness of the method over traditional Protein L ELISAs. This highly sensitive kit detects Protein L levels <600 pg/mL in just under two hours – about half the time needed to run a traditional Protein L assay.
Gain critical insights into your manufacturing process with this fast and reliable ELISA kit from experts in bioprocess impurity detection. For more information, please reach out to your Bio-Connect account manager, or request a quote directly (quotes@bio-connect.nl).
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