Biologics PK
Pharmaron provides comprehensive biologics pharmacokinetics (PK) services that include discovery PK, preclinical PK and clinical PK services. Discovery and preclinical PK studies are conducted in AAALAC-accredited animal facilities by scientists that follow study protocols reviewed and approved by IACUC. Clinical PK studies are performed in our clinical pharmacology center by our experienced medical staff.
The corresponding bioanalysis is performed in laboratories equipped with state-of-the-art instruments, led by bioanalytical scientists to support discovery, preclinical and clinical PK needs. The studies can also be conducted in an environment meeting GLP or GCLP and GCP requirements, as outlined by ICH, FDA, EMA and NMPA.
Capabilities
Discovery PK for Biologics
- Species: rodents and large animals
- Admin routes: IV, IV infusion, IP, IM, SC, ICV and IT
- Bioanalytical method development
- Bioanalysis of samples taken from the study
- Biologics exposure measured in plasma at different time points
- Biologics exposures in other biomatrices at different time points (biofluids and tissues)
- Immunogenicity evaluation by measuring ADA, Nab, and other ADCC and CDCC, ADCP, TDAR
- Biomarker analysis designed for biologics testing
Discovery PK for Biologics
- PK parameters using WinNonLin PK models
- PK/PD correlation study
- Animals of selected species, healthy or diseased, are dosed with a therapeutical dose
- Bioanalysis of levels of biologics and PD biomarkers in plasma and tissues at different time points
- Establishment of PK/PD correlation
Discovery PK for Biologics – Analytes
- Recombinant proteins, peptides
- Antibodies, e.g. mAbs, ADCs, PDCs, Bis-Abs, nanobodies
- Vaccines
- Biomarkers, including DNA, mRNA and small molecule-based biomarkers
Preclinical PK for Biologics
- Species: rodents and large animals
- Admin routes: IV, IV infusion, IP, IM, SC, ICV, IT
- Bioanalytical method development and validation
- Bioanalysis of samples taken from the in-life study
- Biologics exposure measurement in plasma at different time-points
- Biologics exposures in various other biomatrices at different time points (biofluids and tissues)
- Immunogenicity evaluation by measuring ADA, Nab, and other ADCC and CDCC, ADCP, TDAR
- Biomarker analysis designed for biologics testing
- Biodistribution analysis of exposure to various tissues
- Mass balance study
- PK parameters using WinNonLin PK models
Preclinical PK for Biologics – Analytes
- Recombinant proteins, peptides
- Antibodies, e.g. mAbs, ADCs, PDCs, Bis-Abs, nanobodies
- Vaccines
- Biomarkers, including DNA, mRNA and small molecule-based biomarkers
- Support IND filing with regulatory agencies, including NMPA, FDA and EMA
Clinical PK for Biologics
- Subject: healthy volunteers and patient participants
- Administration routes: IV, IV infusion, IM, SC
- Bioanalytical method development and validation
- Bioanalysis of samples taken from the in-life study
- Biologics exposure measurement in plasma at different time-points
- Biologics exposure in various other biomatrices at different time points (plasma, feces and urine)
- Immunogenicity evaluation by measuring ADA, Nab, and other ADCC and CDCC, ADCP and TDAR
- Biomarker analysis as designed for the testing biologics
- PK parameters using WinNonLin PK models
- PK/PD correlation study
Clinical PK for Biologics – Analytes
- Recombinant proteins, peptides
- Antibodies, e.g. mAbs, ADCs, PDCs, Bis-Abs, nanobodies
- Vaccines
- Biomarkers, including DNA, mRNA and small molecule-based biomarkers
- Support clinical studies and BLA filing with regulatory agencies, e.g. NMPA, FDA, EMA
