Resolian can 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 a dedicated team of experienced scientists, Resolian 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).
Platforms
With a focus on large molecule ligand binding assays, Resolian’s team of experts are able to develop methods on a diverse range of platforms:
- Meso Scale Discovery
- Gyrolab
- Envision (fluorescence and absorbance)
Biotherapeutics
Resolian has 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
- Peptides
- Bispecifics (including multi-domain characterization)
- Biosimilars
- Adeno-associated viruses (AAVs): gene therapy
Bioanalytical Programs
To support bioanalytical programs, Resolian provides:
- An experienced method development team and assigned technical specialists to ensure your assay meets your specifications
- Key method development decisions and analytical data that are summarized and shared with customers in real time
- An independent Principal Scientist team which ensure that developed/validated methods meet regulatory requirements
- A 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 offering sample reconciliation, data transfers (including SDTM and SEND data standards), report tables and figures tailored to your specifications
- PK and TK parameter analysis using Phoenix WinNonlin for non-compartmental data analysis (NCA)