Bioanalytical Services

Robust bioanalytical support across the drug development lifecycle — from assay development to clinical sample testing and biomarker analysis.

Comprehensive Bioanalytical Capabilities

Vaccelix Biopharma delivers GLP/GCP-aligned bioanalytical services to support preclinical and clinical programs. Our laboratory provides validated methods, high-throughput sample processing, and specialized assays for small molecules, biologics, and advanced modalities.

Our Core Bioanalytical Services

  • Method development & validation: LC-MS/MS, HPLC, GC, ELISA, and ligand-binding assays tailored to regulatory requirements.
  • PK/PD analysis: Pharmacokinetic and pharmacodynamic sample testing with sensitive, reproducible assays.
  • Immunogenicity & ADA testing: Screening and confirmatory assays to evaluate anti-drug antibodies and immune responses.
  • Biomarker discovery & quantitation: Multiplex assays, targeted proteomics, and biomarker validation to support translational decisions.
  • Sample management & chain-of-custody: Secure cold-chain handling, aliquoting, storage, and sample tracking for global trials.

Our bioanalytical teams work closely with formulation, clinical, and regulatory groups to ensure results are actionable, well-documented, and aligned with study objectives. We emphasize rapid turnaround, data integrity, and flexible capacity to support accelerated timelines.

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Bioanalytical Laboratory Instruments

High-Sensitivity Assays

Assays with low limits of quantification for demanding PK studies and biologic analytics.

GLP/GCP Compliance

Validated processes, audit-ready documentation, and secure data management systems.

Scientific Partnership

Dedicated project teams, study design input, and collaborative data review with sponsors.