title: Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis performance.
abstract: BACKGROUND
  A microfluidic platform-based assay was validated to measure a humanized or fully human IgG in rat serum samples.
  
  
  METHODS
  The cumulative assessment for accuracy and precision was performed with three accuracy and precision runs.
  
  
  RESULTS
  The inter-assay accuracy (mean %bias) ranged from -4.3 to 3.8%, and inter-batch %CV ranged from 5.0 to 9.2%. The method acceptance criterion was determined as 15% total error. The assay dynamic range was 50 to 10000 ng/ml. Incurred sample reanalysis passed with 95% of samples meeting incurred sample reanalysis acceptance criteria. Potential carryover effect was not observed.
  
  
  CONCLUSIONS
  This study demonstrated the need for evaluating additional platform-specific processes when new technologies are employed to ensure the reproducibility of a successfully validated microfluidic platform method.
authors.affiliation: Department of Pharmacokinetics & Drug Metabolism, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
authors.forename: Ivan
authors.initials: I
authors.lastname: Magana
authors.forename: Chris R
authors.initials: CR
authors.lastname: Macaraeg
authors.forename: Liana
authors.initials: L
authors.lastname: Zhang
authors.forename: Mark
authors.initials: M
authors.lastname: Ma
authors.forename: Theingi M
authors.initials: TM
authors.lastname: Thway
mesh_terms: D000818:Animals; D000906:Antibodies / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D051379:Mice; D044085:Microfluidics / Q000379:methods*; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000906:Antibodies