PK, PD AND BIOMARKERS
Everything needed for successful drug development.
Combining early PK with POC efficacy studies, we provide alignment of compound kinetics from in vitro metabolism through PD and PK testing. TD2 offers Proof of Concept (POC) for both small and large molecules of interest and provides support in the following areas:
- Pharmacokinetic noncompartmental analysis using Phoenix WinNonlin software
- Tissue distribution
- Analysis of large molecules
- Dried Blood Spot (DBS) analysis
- LC-MS/MS and UV-VIS dose confirmation, in support of dose escalation studies
A Complete DMPK laboratory to support your assay needs.
When you partner with TD2, you can be confident that your sample analyses and results are highly reproducible and accurate. We can help tailor your DMPK panel to meet your therapeutic candidate’s requirements. Our DMPK laboratory, located within our AAALAC-accredited, state-of-the-art vivarium, is the ideal environment for cancer drug discovery to properly assesses quantitative pharmacokinetic testing and toxicokinetic analyses.
We provide bioanalytical method development and/or transfer under a non-GLP environment with proper evaluation based on FDA guidance.
Our instrumentation includes one of the most highly sensitive LC-MS/MS equipment available, the Waters Xevo TQ-S and Acquity I-class UPLC system.
Other DMPK services we support:
- Physiochemical properties including chemical stability
- Stability in hepatic fractions, such as S9, microsomes and hepatocytes
- CYP inhibition using microsomes or recombinant enzymes (supersomes)
- High throughput screening for CYP inhibition
- Plasma stability
- Phenotyping in CYP or UGT enzymes
- PAMPA screening for permeability assessment
- Protein binding including tissue binding, blood-to-plasma ratio, and plasma protein binding
- Bioanalytical method development and validation
PK, PD AND BIOMARKERS
Advanced biomarker assays and analytical readouts.
Trust your research with a team of oncology experts that keep the end goal in mind. TD2 helps advance screening studies by offering various specialty assays from tumor immune cell infiltrate profiling to quantitation of the effect of therapy on the microbiome. In addition, access a wide range of standard applications through the cutting-edge MesoScale Discovery platform including:
- Cytokines and chemokines
- Cell signaling pathways
- Angiogenesis and hypoxia markers
- Growth and vascular factors
- Metabolic markers
- Cell based assays
- Phosphoprotein analyses
PRECLINICAL
Models and Services
TD2’s service offering is consistently expanding and currently includes:
- Non-GLP Safety/Tolerability
- In vitro Pharmacology Assays
- DMPK/ADME services
- Tumor Xenograft Models
- Patient-derived tumor xenograft models (GBM)
- Syngeneic Tumor Models
- Orthotopic Tumor Models
- Adoptive Cell Therapy Models
- In vivo Optical Imaging
- Flow Cytometry
