Precision advances the development of complex therapeutics including small peptides, antibody-drug conjugates (ADCs), PEGylated proteins, monoclonal and bispecific antibodies, and cell-based therapies like CAR-T, with a range of bioanlytical services.
To support PK studies at all phases of development, we offer assay development, validation, and implementation using ELISAs and MesoScale Discovery (MSD) assays for biologics, and flow cytometry and Droplet Digital PCR (ddPCR) for cell-based therapies. Additionally, Precision utilizes the SIMOA platform to perform PK assays at extreme sensitivity, which can be critical for the success of dose-escalation studies.
PK assays for biologics and cell-based therapeutics
We offer assay development, validation, and implementation to obtain the following PK data:
Precision can address your assay development, validation, and testing needs from preclinical through pivotal trials.
- Unparalleled scientific leadership
- Fit-for-purpose – design, qualify, validate (GLP, GCLP, CLIA) the right assays at the right time
- Global scale – logistics to support global sample collection and storage in a 100,000 square foot state-of-the-art CAP-accredited and ISO-certified facility
Integrating biomarker and clinical trial data
Precision has built a proprietary informatics platform, QuartzBio, to help researchers understand and interpret PK data in the context of other pharmacodynamic (PD)-related biomarker assay data, as well as in the context of key clinical trial annotations
Global reach, multi-site support
Our PK services support pre-clinical and clinical research, including multi-site studies, conducted anywhere in the world.
Working with Precision
Precision’s specialty lab scientists take a collaborative and consultative approach to projects and can provide recommendations on biomarker assay strategies and implementation. Services can be provided individually or as part of a comprehensive therapeutic development package including biomarker assays and clinical trials.
MesoScale Discovery (MSD) Assays
Measure a range of analytes in complex samples matrices consistently and at high sensitivity with our MSD assay capabilities. Applications include ADA, NAb, and TAb assays, PK assays, and more.
Quanterix SIMOA provides precise quantification of analytes in multiple matrices at ultra-high sensitivity. This platform can measure targets present at femtomolar (fM) levels, enabling analysis of analytes that may have been previously undetectable.
We offer assay development, validation, and implementation using ELISAs and MesoScale Discovery (MSD) assays for biologics; flow cytometry and Droplet Digital™ PCR (ddPCR) for cell-based therapies; and Quanterix SIMOA® for ultrasensitive detection.