The Sword Difference
Sword Bio is the obvious choice for clients who want expert results quickly and affordably. Our scientific team leads the industry in the development, qualification, and validation of sensitive quantitative assays to measure the pharmacokinetic (PK) activity of your novel therapeutic drug. Our services can be run under research or GLP conditions.
How Our Team Can Help
Pharmacokinetic (PK) studies are critical in the research and development of novel therapeutic drugs. PK assays allow insight into the safety and effectiveness of the drug and help guide appropriate dosage for preclinical and clinical studies.
Sword scientists will work with your team to develop and validate PK assays exhibiting:
- Multi-matrix analysis (Urine, Stool, CSF, Saliva, and Tissue homogenate)
- Calibration curve and range
- Accuracy and precision
- Minimum required dilution (MRD)
- Selectivity and specificity
- Dilutional linearity
- Short- and long-term stability
- Freeze-thaw stability
Comprehensive Pharmacokinetic Assay Development for All Program Stages
Pharmacokinetics is the assessment of how the body impacts the biotherapeutic, characterized at the most basic level by quantitating the drug in non-clinical and clinical samples. At Sword Bio, our PK assay development process is engineered to support programs ranging from rapid exploratory screening to full GLP validation for IND-enabling and clinical studies. Our scientists partner closely with sponsors to evaluate modality,, matrix considerations, and biological complexity, ensuring assays are optimized for sensitivity, reproducibility, and regulatory readiness.
Our team supports biologics, such as: monoclonal antibodies, peptides,, engineered proteins, and antibody–drug conjugates (ADCs). Whether your goals involve early discovery decision-making or submission-quality PK datasets, we provide a tailored, collaborative workflow to accelerate program progression.
Advanced Ligand-Binding Assay
Sword Bio offers a full suite of ligand-binding assay (LBA) platforms—including ELISA and MSD (electrochemiluminescent detection)—to match sensitivity, selectivity, and matrix requirements.
Our PK method development incorporates:
- Strategic selection of assay format
- Identification of optimal limits of detection, dynamic range, and assay precision targets
- Qualification of assay with a fit for purpose approach
- Matrix-specific evaluations for plasma, serum, CSF, urine, tissue homogenates, and other sample types
GLP PK Assays, Toxicokinetics (TK), and Regulatory-Ready Reporting
For IND-enabling and clinical programs, Sword Bio performs full GLP assay validation aligned with FDA, EMA, and ICH bioanalytical method validation guidelines. Every GLP study includes SOP-driven execution and comprehensive QA review.
Our GLP services include:
- ICH M10-compliant method validation
- Detailed quality assurance reviews and regulatory-ready final reports
Our team works directly with client study directors to ensure data packages align with submission expectations and downstream modeling requirements.
PK–PD Integration and Translational Insight
Understanding PK alone is rarely sufficient. Sword Bio supports integrated PK/PD study designs that help sponsors connect drug exposure to downstream biological effects. When paired with biomarker, and/or ADA data, PK results can inform mechanism of action, dose justification, target engagement, and risk–benefit assessment.
High-Throughput Workflow and Rapid Turnaround
Sword Bio’s bioanalytical infrastructure is built for speed and scalability. Using streamlined assay development pipelines, we accommodate large sample volumes while maintaining rigorous standards. Rapid feasibility assessments and flexible scheduling ensure that PK data are delivered on time—even when programs involve compressed timelines, accelerated nonclinical studies, or overlapping clinical cohorts.