Sword Bio: Immunogenicity Assays from Method Development to Sample Analysis
A bioanalytical CRO that builds and runs ADA and neutralizing antibody assays for biologics, now orderable on the Cypher AI Marketplace.
By Cypher AI ·
WHAT IS SWORD BIO?
Sword Bio is a bioanalytical contract research organization (CRO) that develops, validates and runs pharmacokinetic (PK), immunogenicity and biomarker assays for biotech and pharma programs. Sword Bio has offices in Carmel, Indiana, and labs in Chicago. As of October 2026, Sword Bio's immunogenicity service is listed on the Cypher AI Marketplace.
Sword Bio's scientists average more than 20 years of experience. Beyond immunogenicity, Sword Bio also offers PK, custom biomarker, MSD, cell-based and molecular assay services.
WHAT PROBLEM DOES IMMUNOGENICITY TESTING SOLVE?
Immunogenicity testing tells a team whether patients or study animals are making anti-drug antibodies (ADAs) against a biologic, and whether some of those antibodies are neutralizing antibodies (NAbs) that block the drug's activity. ADAs can change a drug's exposure, reduce its effect or raise safety questions.
The FDA's 2019 guidance on ADA assays lays out a tiered set of screening, confirmatory, titration and neutralization assays for therapeutic proteins in clinical trials. For a biologics team, that usually means planning several linked assays for each molecule well before the first clinical samples arrive.
Immunogenicity assays are drug-specific, so an assay built for one antibody usually has to be rebuilt for the next. The format depends on the molecule: Sword Bio notes that bridging assays are commonly used for bivalent antibodies, and direct-binding formats tend to suit monovalent or structurally complex therapeutics.
Drug in the sample is a common complication. A team moving a bispecific antibody into IND-enabling studies, for example, often needs an ADA assay that still detects antibodies while circulating drug is bound to them. Sword Bio offers drug-tolerant methods for this, including acid dissociation, affinity capture elution (ACE) and solid-phase extraction with acid dissociation (SPEAD).
WHAT CAN YOU ORDER FROM SWORD BIO ON CYPHER AI?
As of October 2026, Sword Bio lists one service on the Cypher AI Marketplace, called Immunogenicity. It covers ADA and NAb assays from method development through sample analysis, for nonclinical and clinical studies. The service is priced by quote, and Sword Bio sets the price and timeline with you based on the molecule and the study.
Sword Bio takes a staged approach. In early nonclinical work, the focus is fast assay development and qualification to support candidate selection. As a program moves into IND-enabling and clinical stages, Sword Bio expands assay validation and adds GLP-compliant workflows. Sword Bio also runs solution-based and cell-based NAb assays, and AAV vector immunogenicity screening for gene therapy programs.
FREQUENTLY ASKED QUESTIONS
What is the difference between an ADA assay and a NAb assay? An ADA assay detects antibodies against the drug, whatever their effect. A NAb assay tests whether those antibodies block the drug's activity, using either a cell-based format or a competitive ligand-binding format.
Does Sword Bio support GLP studies? Yes. Sword Bio supports both regulated and non-regulated studies, including GLP- and GCLP-compliant programs.
Can Sword Bio run immunogenicity and PK assays in the same lab? Yes. Sword Bio can run its ADA and NAb assays alongside PK or biomarker studies.
HOW DO YOU ORDER FROM SWORD BIO ON CYPHER AI?
You can browse Sword Bio's listing at cypherbio.ai/services without an account. To request a quote or place an order, create a free Cypher AI account. Sword Bio sends the quote, and you pay Sword Bio directly by purchase order, card or invoice.
When you order from a Cypher AI project, the order records the study's ELN entry and LIMS samples, so each set of results can be matched to the samples you sent.