What Does a Bioanalytical Lab Measure for a Drug Program?
PK, immunogenicity, cell-based potency and biomarker assays: what each one tells a program, when it's needed, and the labs on the Cypher AI Marketplace that run them.
By Cypher AI ·
Most drug programs depend on specialist bioanalytical labs for the data that sets dose, flags safety signals and decides whether a candidate moves forward. Few internal teams run all of those assays in-house.
These specialist labs bring deep assay expertise, but working across them can mean managing separate portals, emails and phone calls. On the Cypher AI Marketplace, teams can find their services and manage orders in one place.
WHAT DOES A BIOANALYTICAL LAB MEASURE?
A bioanalytical lab quantifies a drug, and the biological response to it, in study matrices such as plasma, serum and tissue. The core assay families are pharmacokinetics (PK), with toxicokinetics (TK) in GLP tox studies, immunogenicity, cell-based potency and biomarkers. Gene therapy programs add biodistribution and shedding.
Each family feeds a different decision. PK and TK set exposure and dosing, and immunogenicity flags anti-drug antibodies (ADAs) that can change exposure or safety. Potency and biomarker data then show whether the mechanism is engaged.
HOW IS PK MEASURED FOR BIOLOGICS AND SMALL MOLECULES?
PK for large molecules is usually measured with ligand-binding assays such as ELISA or MSD, while small molecules and many peptides go to LC-MS/MS. For regulated studies, both kinds of method are validated under ICH M10, which FDA finalized in November 2022.
PK and ADA results are read together, since ADAs can change exposure, so many teams run both at one lab. Sword Bio, a bioanalytical CRO, runs PK assays alongside its immunogenicity work.
WHAT DOES AN IMMUNOGENICITY STRATEGY INCLUDE?
An immunogenicity strategy for a biologic is a tiered set of ADA assays. FDA's 2019 guidance on ADA assays describes screening, confirmatory and titration assays, then a neutralizing antibody (NAb) assay to show whether the ADAs block the drug's activity.
ADA methods are drug-specific, so each new molecule needs its own. Circulating drug can also mask ADAs, which makes drug tolerance part of method development. Acid dissociation, affinity capture elution (ACE) and solid-phase extraction with acid dissociation (SPEAD) are common ways to improve it.
Sword Bio has offices in Carmel, Indiana, and laboratories in Chicago, where it develops, validates and runs ADA and NAb assays. The team selects bridging or direct-binding formats based on the molecule's structure. Its services span rapid development and qualification for candidate selection through validated, GLP-compliant methods for IND-enabling and clinical studies. Sword Bio's scientists average more than 20 years of experience.
WHAT DO CELL-BASED AND BIOMARKER ASSAYS ADD?
Cell-based assays test function, such as cytokine release in PBMCs, T-cell activation, ADCC and CDC. Multiplex immunoassays then profile what the cells secrete. For a cytokine-modulating antibody, a team might run a PBMC cytokine release assay, profile the supernatants on a Luminex panel and confirm the lead analyte by ELISA or Ella.
SBH Sciences runs that kind of work from Natick, Massachusetts, where it has run cell-based bioassays, immunoassays and biomarker analysis since 1997. SBH lists more than 360 validated cell-based assays and works with nearly 400 human cancer cell lines. Its biomarker group covers ELISA development, multiplex analysis and automated Western blots.
WHICH LABS ON THE CYPHER AI MARKETPLACE RUN THESE ASSAYS?
As of October 2026, SBH Sciences and Sword Bio cover cell-based, biomarker and immunogenicity work on the Cypher AI Marketplace.
SBH lists six services, and five have a listed price. In-vitro bioassays and ELISA are $1,500 per 96-well plate, Ella is $800 per 16-sample cartridge, Luminex profiling is $2,000 for panels of up to 100 analytes, and automated Western blot on Jess is $100 per capillary. Kits and reagents are extra, custom assay development is quoted, and turnarounds start at two weeks.
Sword Bio lists one service, Immunogenicity, covering ADA and NAb assays from method development through sample analysis for nonclinical and clinical studies. It includes bridging and direct-binding ADA formats, solution-based and cell-based NAb assays, and AAV vector immunogenicity screening for gene therapy programs. Sword Bio quotes each project based on the molecule and the study.
FREQUENTLY ASKED QUESTIONS
When does a biologic program need ADA assays? Early. ADA methods are drug-specific and take time to develop and make drug-tolerant, so teams usually build them during nonclinical work and validate them before clinical samples arrive.
Do these labs support GLP studies? Sword Bio supports GLP- and GCLP-compliant programs. SBH's work is preclinical research, so teams that need GLP should confirm scope and quality documentation with SBH before ordering.
Does ICH M10 cover immunogenicity and biomarker assays? No. M10 covers PK and TK methods. ADA assays follow FDA's 2019 immunogenicity guidance, and M10 leaves biomarker assays out of its scope.
HOW DO YOU ORDER BIOANALYTICAL ASSAYS ON CYPHER AI?
You can browse SBH's and Sword Bio's listings at cypherbio.ai/services without an account. To order, create a free Cypher AI account. SBH's priced services can be ordered directly, and Sword Bio sends a quote. You pay each lab directly.
When you order from a Cypher AI project, each order records the project, ELN entry and LIMS samples it came from. Each lab's data files arrive on its order, where you can add them to the project.