title: A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins.
abstract: Outsourcing and multi-site testing has increased for ligand binding assays supporting protein therapeutic measurement. It is common to combine and compare data across studies with data from multiple bioanalytical sites. We designed a prospective study to determine the benefits of increasing control over the transfer process to improve ruggedness. The experiment involved the testing of 30 incurred samples at 3 stages with incremental laboratory harmonization in standard/quality controls and assay components: Stage I represented a transfer of a detailed protocol and critical reagents. Stage II, a single source of standards and quality controls were provided to each site. Stage III, standards and quality controls plus a ready-to-use kit were provided. The results indicated that all testing facilities failed agreement testing using the stage I procedure. The introduction of standards from a single source improved the agreement. The modification reduced variation by 33% compared to the stage I approach. There was no additional benefit when a packaged kit was provided. In conclusion, introduction of a single source of standards and quality controls reduced the inter-site component of variation and should allow for combinability of data.
authors.affiliation: Pharmaceutical Services, Radix BioSolutions, Georgetown, TX, United States. caray@radixbiosolutions.com
authors.forename: Chad A
authors.initials: CA
authors.lastname: Ray
authors.forename: Lei
authors.initials: L
authors.lastname: Zhou
authors.forename: Jennifer
authors.initials: J
authors.lastname: Tsoi
authors.forename: Lennie
authors.initials: L
authors.lastname: Uy
authors.forename: Jessie
authors.initials: J
authors.lastname: Gu
authors.forename: Jennifer
authors.initials: J
authors.lastname: Malella
authors.forename: Danielle
authors.initials: D
authors.lastname: Desimone
authors.forename: Han
authors.initials: H
authors.lastname: Gunn
authors.forename: Mark
authors.initials: M
authors.lastname: Ma
authors.forename: Jean
authors.initials: J
authors.lastname: Lee
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D006801:Humans; D008024:Ligands; D011446:Prospective Studies; D011506:Proteins / Q000032:analysis* / Q000493:pharmacokinetics; D011786:Quality Control
chemical_list: D008024:Ligands; D011506:Proteins