Analytical Method Development & Validation
At Pre-therapeutic, we specialise in developing and validating robust analytical methods to support early-stage drug development, with a strong focus on High-Performance Liquid Chromatography (HPLC). Our expertise ensures reliable characterisation and quantification of complex molecules, even at low concentrations, across both diagnostic and therapeutic applications.
HPLC Method Development
We design fit-for-purpose HPLC methods for:
- Small molecule drug candidates and intermediates
- Radiolabelled compounds (e.g. 18F, 64Cu, 68Ga, 99mTc)
- Metal-based radiotherapeutics (e.g. 177Lu, 212Pb)
Our development process is tailored to the unique challenges of early-stage programmes, including limited material availability, formulation complexity, and the need for rapid turnaround.
HPLC Method Validation
We provide fit-for-purpose validation to ensure confidence in your results while maintaining flexibility for evolving programmes. Validation is performed in line with ICH Q2(R2) and includes:
- Specificity and selectivity
- Linearity and range
- Accuracy and precision
- LOD/LOQ and system suitability
Our goal is to deliver scientifically sound, phase-appropriate methods that are ready for regulatory submission when needed.