Seamless Bioanalytical Assay Transfers for PK and Immunogenicity Studies
What is an assay transfer and why is it important in bioanalytical studies?
An assay transfer is the process of moving a validated analytical method from one laboratory to another, ensuring consistent performance and reproducibility. It is crucial in bioanalytical studies to maintain data integrity, regulatory compliance, and reliable results across different testing sites, especially in drug development and clinical trials.
In today’s shifting and uncertain landscape, many sponsors face unexpected disruptions to their bioanalytical analysis work. These disruptions can cause significant setbacks in drug development timelines. That’s why IQVIA Laboratories Biosciences offers seamless assay transfer services for pharmacokinetics (PK) and immunogenicity studies, ensuring minimal disruption, reduced risk, and continued program success.
Here's how we can help.
Click on each area below to see how we can simplify your assay transfers.
PK assay transfer strategy for large and small molecules
We simplify PK assay transfers—whether for large or small molecules—through proven processes and scientific rigor.
Our services include:
Method transfer
Technical transfer of a fully developed or validated method.
Initial direct method transfer
- Direct transfer of existing completed method
- Testing using all critical reagents, matrix standards/QCs qualified by the originator laboratory
- Stable labeled internal standard
- May include substitution of common equivalent reagents such as PBS, PBS+Tween, substrate, sodium carbonate, BSA, etc.
- May include IQVIA Laboratories preparation of standards/QCs for comparison
- Confirmation of or selection of calibration curve fit model if Watson not originator regression program
Pre-validation parameter testing
- Evaluation of the following:
- Dilutional linearity
- Selectivity NHV and/or disease state
- Hemolysis and lipemia (icterus as appropriate)
- Accuracy and precision
- Known or anticipated interferents
- Confirmation of LLOQ
- Assessment of short-term stability/fresh-frozen
- Evaluation of robustness
Immunogenicity Assay Transfer Strategy
IQVIA Laboratories Biosciences offer a comprehensive immunogenicity assay transfer strategy, including:
Method development
Technical transfer of a fully developed or validated method.
Initial direct method transfer
- Direct transfer of existing completed method
- Testing using all critical reagents, matrix, controls, conjugates qualified by the originator laboratory
- May include substitution of common equivalent reagents such as PBS, PBS+Tween, substrate, sodium carbonate, BSA, etc.
- May include IQVIA Laboratories preparation of controls and conjugates for comparison
- Careful assessment of instrument response characteristics for MSD testing
Pre-validation parameter testing
- Determine the NC pool
- Assessment of screening, confirmation and titer cut-points
- Confirmation of method sensitivity
- Confirmation of selectivity
- Recommendations for positive control (PC) levels
- Confirmation of drug tolerance
- Assessment of domain specificity for multidomain modalities
What information does a sponsor need to provide for a successful assay transfer?
- Validation report and if available, a method development report
- Raw data and representative calibration curves, including QC back-calculations from greater than one scientist
- Critical reagent identity, availability, characteristics (e.g., blocking or non-blocking anti-ids), batch history
- Qualified matrix standards and QC samples, small pool of matrix for IQVIA Laboratories small batch preparation/test
- Properties of the drug (mass, structure, reconstitution, extinction coefficient, formulation buffer, stability)
- Clear communication of the nature of the drug provided for development (e.g., research material, test article, drug substance, drug product)
- Mode of action, potential for target interference, specificity, or other binding events
- Disease state requirements to allow appropriate procurement and timelines for receipt
