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Sword Bio

Bioanalytical CRO for PK, immunogenicity, and biomarker assays

Bioanalytical CRO offering ligand binding assay development, PK, immunogenicity (ADA and NAb), and custom biomarker assays under non-GLP, spirit-of-GLP, and GLP conditions. Supports clients from discovery through clinical Phase IV.

Phases

Services

Modalities

Technical specifications & accreditations

About this organization

Overview

Sword Bio is a bioanalytical contract research organization that supports biotechnology and pharmaceutical companies with assay development, validation, and sample analysis. The company describes its scope as extending from discovery through clinical Phase IV trials.

Bioanalytical services

  • Bioanalytics: Development, optimization, qualification, and validation of ligand binding assays (LBAs), run under non-GLP, spirit-of-GLP, or GLP conditions.
  • Pharmacokinetics (PK): Development and validation of sensitive quantitative assays for novel therapeutic drugs, under non-GLP, spirit-of-GLP, or GLP conditions.
  • Custom biomarkers: Quantitative assays for protein and non-protein biomarkers of drug efficacy, toxicity, and disease in preclinical or clinical samples.
  • Immunogenicity: Development and validation of ADA and NAb methods tailored to client projects.
  • Commercial biomarkers: MSD singleplex and multiplex immunoassays for drug discovery, development, and clinical validation.
  • Sword SWIFT: A program intended to improve the performance of drug discovery and development assays.
  • Cell-based services: Custom and commercial cell-based assays, bioassays, and cell culture services.
  • Molecular services: Method development and testing using qPCR, dPCR, cell sorting, viral vectors, and PK/PD molecular genomics.

Quality and operating model

The company lists GLP, GCP, and Non-GLP work, and describes offering GLP, GCP, and RUO laboratory capabilities. It also describes an excess capacity model intended to start client projects quickly and states that project planning can be completed before reagents arrive.

Focus areas

Sword Bio states that it applies its bioanalytical expertise to biologics, including monoclonal antibodies, fusion proteins, and cytokines, as well as cell and gene therapy and antibody-drug conjugate programs. Its website also references a 2026 collaboration with Alturas Analytics for complementary large- and small-molecule bioanalysis.

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