Comprehensive PK/TK Support for Large Molecule Therapeutics

At Avantia Labs, we specialize in
bioanalytical pharmacokinetic (PK) and toxicokinetic (TK) studies for biologics, peptides, and gene therapy products.
Our team provides end-to-end analytical and regulatory support to help you understand the absorption, distribution, metabolism, and elimination (ADME) profiles of your therapeutic candidates with scientific precision and regulatory confidence.

Specialized PK/TK CRO Services for Biologics and Peptides

One of our main business activities is pharmacokinetic (PK) / toxicokinetic (TK) analysis of large molecule biologics from discovery phase to preclinical and clinical phases. We analyze large molecule drug candidates, such as monoclonal antibodies, protein, peptides, enzymes and all their derivatives.
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Our Expertise

Biologics & Biotherapeutics

  • Monoclonal antibodies (mAbs)
  • Fusion proteins and peptides
  • Antibody-drug conjugates (ADCs)
  • Gene and cell therapy products

Bioanalytical Platforms

  • Ligand-binding assays (LBA) using MSD, ELISA, or ECL platforms

  • Hybrid LC-MS/MS assays for peptides or antibody fragments

  • Cell-based functional assays to evaluate bioactivity and receptor binding

  • Immunogenicity (ADA/NAb) testing integrated with PK studies

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PK/TK Study Capabilities

Method Development and Validation
• Fully compliant with GLP, GCLP, and 21 CFR Part 58 standards
• Assay design following FDA, EMA, and ICH M10 bioanalytical guidelines
• Robust characterization of assay specificity, sensitivity, accuracy, and precision

Sample Analysis
• Plasma, serum, CSF, or tissue matrices
• High-throughput sample processing under validated conditions
• Real-time data tracking and chain-of-custody management

Study Support
• Nonclinical PK/TK studies (rodent, non-rodent)
• First-in-human and clinical PK sample analysis
• TK assessment in repeat-dose toxicity studies
• Bioavailability and dose-response correlation

Integrated Bioanalytical Solutions

Our PK/TK programs are designed to integrate seamlessly with immunogenicity, biomarker, and potency studies.

This holistic approach ensures data consistency and accelerates regulatory submissions by maintaining a
single, traceable bioanalytical workflow across all study phases.