At TRACER™ we have world-renowned molecular pharmacists, tumour immunologists, biochemists, and pharmacists available for the development and optimization of innovative fluorescent and/or theranostic agents varying from antibody-based, nanobody-based, peptide-based and nanoparticle-based compounds. The team can provide the necessary building blocks for not only developing novel diagnostic imaging agents, but also for theranostic compounds and nanoparticles.
Within our preclinical and clinical certified facilities, we offer a spectrum of (pre-) clinical in vitro to in vivo validation. We provide the complete evaluation package of your GLP and ultimately GMP produced fluorescent tracer within our GMP facility, fully adhering and compatible with FDA/EMA regulations. At the Translational Oncology Laboratory, a vast array of human cancer cell lines are at our disposal, of which a multitude are bioluminescent for in vitro evaluation, including near-infared FACS and microscopy analyses. These same bioluminescent cancer cell lines can be used for in vivo xenotransplants and evaluation in our Preclinical Imaging facility. In this dedicated facility we have state-of-the-art imaging systems installed such as IVIS Spectrum, FMT2500, microCT, uSPECT, small animal PET and MRI, delivering the necessary data on tumor-specificity, biodistribution, pharmacokinetics and initial toxicity. Further, we provide access to clinical camera systems dedicated to your tracer and wavelength with the highest sensitivity possible to evaluate the tracer in the right clinical setting i.e. molecular fluorescence guided surgery by open-air surgery, minimal invasive surgery (laparoscopy, robot-assisted surgery), image-guided pathology and flexible fluorescence endoscopy.
Given our unique setting with all facilities under one roof, as well as our positioning within the field of tracer development and translational evaluation, we also offer the next steps towards clinical translation. Together with our partners, we offer limited or full toxicity studies of your GLP product towards GMP production, and IMPD compilation towards a phase 0 trial in healthy volunteers according to GCP / IHCP regulations. Subsequently, we cover the whole trajectory from phase I (safety and dose-finding), phase II (safety and envisioned clinical effect) up to phase III, in which your tracer is compared to the standard of care for a certain indication using state-of-the-art eCRF and imaging evaluation study protocols and data storage.
As part of our (inter-)national network, multicentre clinical studies are within our competency to provide the evidence of efficacy for your specific clinical indication. These are coordinated together with our Pharmacy Drug Trial Unit, Trial Coordination Center and clinicians.