Bypassing nonparallelism of a monoclonal antibody ligand-binding assay by employment of alternative assay formats
Determination of concentration-time profiles in cynomolgus monkeys of a therapeutic monoclonal antibody against a soluble target revealed a substantial discrepancy between a generic anti-human IgG capture/detection and target bridging assay with the target bridging assay leading to dose- and time-de...
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| Veröffentlicht in: | Bioanalysis 2016-12, Vol.8 (24), p.2581-2593 |
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| container_title | Bioanalysis |
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| creator | Kiesgen, Stefan Schröder, Armin Schwarz, Thomas Czupalla, Oliver Braun, Manuela Gnoth, Mark Jean Grudzinska-Goebel, Joanna |
| description | Determination of concentration-time profiles in cynomolgus monkeys of a therapeutic monoclonal antibody against a soluble target revealed a substantial discrepancy between a generic anti-human IgG capture/detection and target bridging assay with the target bridging assay leading to dose- and time-dependent underquantification of drug concentrations, lack of parallelism and subsequently different pharmacokinetic parameters. In contrast, plasma levels derived from a target capture and an anti-idiotypic antibody bridging assay were in close concordance with the generic assay and demonstrated parallelism with high precision across several dilutions. The results provide a practical attempt to overcome nonparallelism by employing alternative assay formats utilizing tailored assay reagent combinations in order to obtain unbiased pharmacokinetic data. |
| doi_str_mv | 10.4155/bio-2016-0076 |
| format | Article |
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In contrast, plasma levels derived from a target capture and an anti-idiotypic antibody bridging assay were in close concordance with the generic assay and demonstrated parallelism with high precision across several dilutions. 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In contrast, plasma levels derived from a target capture and an anti-idiotypic antibody bridging assay were in close concordance with the generic assay and demonstrated parallelism with high precision across several dilutions. The results provide a practical attempt to overcome nonparallelism by employing alternative assay formats utilizing tailored assay reagent combinations in order to obtain unbiased pharmacokinetic data.</description><subject>Animals</subject><subject>anti-idiotypic antibody bridging assay</subject><subject>Antibodies, Anti-Idiotypic - blood</subject><subject>Antibodies, Anti-Idiotypic - immunology</subject><subject>Antibodies, Monoclonal - blood</subject><subject>Antibodies, Monoclonal - immunology</subject><subject>Antibodies, Monoclonal - pharmacokinetics</subject><subject>Area Under Curve</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Female</subject><subject>generic assay</subject><subject>Half-Life</subject><subject>lack of parallelism</subject><subject>ligand-binding assay</subject><subject>Ligands</subject><subject>Limit of Detection</subject><subject>Macaca fascicularis</subject><subject>Male</subject><subject>matrix interference</subject><subject>minimum required dilution</subject><subject>nonparallelism</subject><subject>Placebo Effect</subject><subject>Rabbits</subject><subject>ROC Curve</subject><subject>soluble target</subject><subject>target bridging assay</subject><subject>target capture assay</subject><subject>Time Factors</subject><issn>1757-6180</issn><issn>1757-6199</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kMtOwzAQRS0EolXpki3yDxichx17CRUvqRIbWEeOPamMHDvYKVL-noSW7pjNzEjn3sVB6Dqjt2XG2F1jA8lpxgmlFT9Dy6xiFeGZlOenW9AFWqf0SacpciFLeYkWeSVESSu5RF8PY69Ssn6HffC9iso5cDZ1OLRY4S74oF3wymHlB9sEM2Jnd8ob0lhv5tiUViNuRgxd78LYgR9-s26A6NVgv-GItCF2akhX6KJVLsH6uFfo4-nxffNCtm_Pr5v7LdE55wPhbQGy0RxyxgyrSm5EJgpFNZWtBMiBFjpj3JSloExoboq8KTiTigvd6tIUK0QOvTqGlCK0dR9tp-JYZ7Se7dWTvXq2V8_2Jv7mwPf7pgNzov9cTYA8AO1-2EdI2oLXUB--KWG19fBP-Q_pt4Eg</recordid><startdate>20161201</startdate><enddate>20161201</enddate><creator>Kiesgen, Stefan</creator><creator>Schröder, Armin</creator><creator>Schwarz, Thomas</creator><creator>Czupalla, Oliver</creator><creator>Braun, Manuela</creator><creator>Gnoth, Mark Jean</creator><creator>Grudzinska-Goebel, Joanna</creator><general>Future Science Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20161201</creationdate><title>Bypassing nonparallelism of a monoclonal antibody ligand-binding assay by employment of alternative assay formats</title><author>Kiesgen, Stefan ; 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In contrast, plasma levels derived from a target capture and an anti-idiotypic antibody bridging assay were in close concordance with the generic assay and demonstrated parallelism with high precision across several dilutions. The results provide a practical attempt to overcome nonparallelism by employing alternative assay formats utilizing tailored assay reagent combinations in order to obtain unbiased pharmacokinetic data.</abstract><cop>England</cop><pub>Future Science Ltd</pub><pmid>27884079</pmid><doi>10.4155/bio-2016-0076</doi><tpages>13</tpages></addata></record> |
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| ispartof | Bioanalysis, 2016-12, Vol.8 (24), p.2581-2593 |
| issn | 1757-6180 1757-6199 |
| language | eng |
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| source | MEDLINE; PubMed Central |
| subjects | Animals anti-idiotypic antibody bridging assay Antibodies, Anti-Idiotypic - blood Antibodies, Anti-Idiotypic - immunology Antibodies, Monoclonal - blood Antibodies, Monoclonal - immunology Antibodies, Monoclonal - pharmacokinetics Area Under Curve Enzyme-Linked Immunosorbent Assay Female generic assay Half-Life lack of parallelism ligand-binding assay Ligands Limit of Detection Macaca fascicularis Male matrix interference minimum required dilution nonparallelism Placebo Effect Rabbits ROC Curve soluble target target bridging assay target capture assay Time Factors |
| title | Bypassing nonparallelism of a monoclonal antibody ligand-binding assay by employment of alternative assay formats |
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