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PK-Assays PK-Assays

Pharmacokinetic (PK) Assays

Assess your therapeutics efficacy and safety profiles with an array of platforms

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 bioanalytical services.

To support PK studies at all phases of development, we offer assay development, validation, and implementation using ELISA and Meso Scale 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.

Precision uses a variety of platforms for PK assays

Based on your therapeutic type, Precision collaborates with you in a platform-agnostic approach to choose the best solution, whether that be MSD, ELISA, or another format:
  • Molecular assays
  • Immunoassay/Ligand-binding Assays
  • Flow cytometry

  • Sensitive molecular assays for challenging drug modalities

    For newer drug modalities such as cell and gene therapies, Precision utilizes real-time polymerase chain reaction (also known as quantitative PCR or qPCR) and Droplet Digital™ PCR (ddPCR) to support discovery, preclinical, and clinical programs.

    Explore ddPCR
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  • Immunoassays for any sensitivity or multiplex needs

    Decide on required sensitivity, high sample throughput, and minimal sample volumes to choose the appropriate ligand binding assay  for your biotherapeutic quantitation

    Explore our immunoassay platforms
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  • Understand how your biotherapeutics are engaging targets with RO assays

    Flow cytometry is an accurate and effective method when used to identify and measure cellular biomarkers in complex subpopulations. As part of our bioanalytical labs, receptor occupancy assays measured via flow cytometry are a powerful tool for evaluating therapeutic engagement and thus efficacy.

    Explore receptor occupancy assays by flow cytometry
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  • Study PK profiles of your unique cell and gene therapies

    Precision's CGT team excels in developing PCR (ddPCR and qPCR) assays for a range of applications in cell and gene therapy. We routinely develop and validate custom PCR assays specific to client gene therapy vectors or cell therapies.

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    For gene therapy

    • Biodistribution
    • Shedding
      • Common human matrices: saliva, urine, feces
    • Transgene expression
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    Nanostring-assay

    For cell therapy

    • CAR T cell (or other cell therapy) persistence/PK
    • Replication-competent lentivirus (RCL) assay
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Extensive experience with advanced platforms for PK analysis

We help you select the best platform for your project based on drug modality, required sensitivity, and regulatory guidance. We have extensive experience developing and validating assays to evaluate PK behavior throughout all phases of the drug development process using the following platforms:

Measure pharmacokinetics for any biologics and cell-based therapeutics

Evidence solutions

Define what you're studying

We offer assay development, validation, and implementation to obtain the following PK data:

  • Absorption
  • Cmax
  • Bioavailability
  • Half-life
  • Clearance
Engagement

Leverage end-to-end assay development support

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
Data convergence

Combine 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

Learn more about the computational, informatics, and sample management capabilities of QuartzBio.

Learn more about QuartzBio®
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Global reach, multi-site support

Our PK services support pre-clinical and clinical research, including multi-site studies, conducted anywhere in the world.

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Consult with Precision for a personalized plan

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.

Related services

  • Explore

    Large Molecule PK

    Development, validation, and implementation using ELISAs and MSD assays for biologics, flow cytometry and ddPCR for cell-based therapies, and Quanterix SIMOA® for ultrasensitive analyte detection
    Explore
  • Explore
    Cytokine

    MesoScale Discovery (MSD)

    Measuring a range of analytes in complex sample matrices consistently and at high sensitivity, with applications including ADA, NAb, TAb, and PK assays
    Explore
  • Explore

    Quanterix SIMOA®

    Precise quantification of analytes in multiple matrices at sensitivity down to femtomolar (fM) levels, enabling analysis of analytes that may have been previously undetectable
    Explore