PK Assay for Therapeutic Antibody Quantification in Sodium Heparin Plasma
Case Study

PK Assay for Therapeutic Antibody Quantification in Sodium Heparin Plasma

Challenge

While conducting the pre-validation stage of a pharmacokinetic assay study, a sponsor asked BioAgilytix to develop a method for analyzing a specific therapeutic antibody when the results generated by another lab were not consistent with what was expected. Upon reviewing the validation report, it was determined that the validation from the other CRO was not performed properly. The validation was not thoroughly QC’ed and was not performed in the proper sample matrix. Therefore, the results from the subsequent sample analysis were not a true representation of the concentration of the drug in the samples.

During validation, the therapeutic antibody was over-recovered after spiking sodium heparin plasma into the sample. BioAgilytix scientists investigated ways to improve and mitigate the recovery of the therapeutic antibody in a tight timeframe by developing a new analysis method.

Study Background

  • Type of Study

    Rescue project – PK Assay

  • Regulatory Parameters

    Validation with stringent quality controls

  • Objective

    Rescue the study in a tight timeframe by developing a method for analyzing a specific therapeutic antibody.

PK Assay for Therapeutic Antibody Quantification in Sodium Heparin Plasma

Solution

Through an iterative process, BioAgilytix scientists determined that a particular concentration and incubation of hexadimethrine bromide (polybrene) was optimal to prevent the interaction of heparin and the therapeutic antibody. The isolated therapeutic antibody was then quantified for the PK assay.

The following areas of expertise were vital to BioAgilytix’s overall solution:

  • Deep understanding of bioanalysis and assay troubleshooting.
  • Considerable expertise in the area of pharmacokinetics and assay development.
  • Exceptional QC experience backed by a sustainable Quality Management System (QMS).
  • Prior experience with quick turnaround and “rescue” projects.

Combining scientific expertise and innovative problem solving, BioAgilytix discovered the issues with the previous CRO’s study and identified a solution for the sponsor.

Outcome

BioAgilytix scientists’ applied expertise allowed for the continuation of the validation of the assay with confidence, and enabled the project to subsequently progress to sample analysis. The method is proving out and providing important data in the project’s clinical development phase.

The revelation of polybrene concentration/incubation for this particular therapeutic antibody quantification was then incorporated into new laboratory protocols for sample analysis.