Translational Medicine

Monique Putman, Manager Biochemistry & Immunology at QPS, on International Team of Experts Exploring the Impact of Immunogenicity on Pharmacokinetic (PK) Assessments – Resultant Recommendations for Bioanalytical Best Practices Captured in American Association of Pharmaceutical Scientists (AAPS) White Paper - April, 2014

The Global Bioanalysis Consortium (GBC) set up an international team to explore the impact of immunogenicity on pharmacokinetic (PK) assessments. The intent was to define the field and propose best practices when developing PK assays for biotherapeutics. The impact of anti-drug antibodies (ADA) on the performance of PK assays was studied to determine whether the observed change in drug concentration results from the ADA impact on drug clearance rates or from ADA interference with the bioanalytical method applied to measure drug concentration. This assessment should guide the bioanalytical scientist in developing ADA-tolerant PK methods. It is essential that the data generated in the PK, ADA, pharmacodynamic and efficacy/toxicity evaluations are viewed together. Efforts to investigate PK sensitivity to the presence of ADA should be modulated according to project needs and the risk at hand.

20 years in pharma R&D navigation