Drug Development Solutions are able to support all your immunoassay bioanalytical requirements for toxicokinetics (TK) & pharmacokinetics (PK) data collection and interpretation, from non-clinical to clinical trials (including phase III).
Through our dedicated team of experienced scientists we will develop bioanalytical methods that meet your requirements and are fully validated in compliance with GLP/GCP regulations and international regulatory standards (FDA and EMEA).
With a focus on large molecule ligand binding assays our team of experts are able to develop methods on a diverse range of platforms:
- Meso Scale Discovery
- Envision (fluorescence and absorbance)
Drug Development Solutions have supported a wide range of drug development programs for biotherapeutics, including:
- Monoclonal Antibodies (mAbs)
- Antibody fragments (Fab, nanobody, domain antibodies)
- Antibody Drug Conjugates (ADCs)
- Proteins: including multi-domain
- Bispecifics (including multi-domain characteristaion)
- Adeno-associated Viruses (AAVs): gene therapy
To support bioanalytical programmes, we have:
- An experienced method development team and assigned technical specialists to ensure your assay meets your specifications
- Key method development decisions and analytical data are summarised and shared with customers in real time
- Independent Principal Scientist team ensure that developed/validated methods meet regulatory requirements
- Dedicated sample management team to receive and batch samples from the central lab. Enabling robust sample control and traceability from patient to results
- A validated LIMS systems enabling fast turnaround of sample analysis results
- Our data management team provide sample reconciliation, data transfers (including SDTM and SEND data standards), report tables and figures tailored to our clients’ specifications
- PK and TK parameter analysis using Phoenix WinNonlin for non-compartmental data analysis (NCA)
For more information about our Pharmacokinetic services please contact us to discuss your requirements.