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Updated: Jan 11, 2026

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Cell-based potency assay for anti-CD3-anti-CD19 diabody.

Tania L Weiss1, Justine Paniagua1, Tonny Johnson1

  • 1Marin Biologic Laboratories, Inc., 378 Bel Marin Keys Blvd, Novato, CA 94949, USA.

Journal of Immunological Methods
|November 13, 2025
PubMed
Summary

A novel cell-based potency assay was developed to measure GP101, a bispecific diabody immunotherapy. This assay quantifies T-cell-mediated killing of B-cell malignancies, ensuring consistent and effective therapeutic development.

Keywords:
BlinatumomabCD3-CD19 diabodyCell-based assaysPotency assayT-cells

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Area of Science:

  • Biotechnology
  • Immunotherapy
  • Assay Development

Background:

  • GP101 is a single-chain diabody immunotherapy targeting CD19-expressing B-cell malignancies.
  • It redirects T lymphocytes (expressing CD3) to B lymphocytes (expressing CD19) for targeted cell lysis.
  • Existing methods require robust assays to ensure efficacy and safety.

Purpose of the Study:

  • To develop a Good Manufacturing Practice (GMP) compliant cell-based potency assay for GP101.
  • To quantify the cytotoxic potency of GP101 against B-cell lymphoma targets.
  • To meet FDA requirements for therapeutic potency assessment.

Main Methods:

  • A cytotoxicity assay utilizing a CD3+ T cell line and a fluorescently labeled CD19+ B cell lymphoma line was developed.
  • Target cell lysis was measured by detecting released fluorescent dye using a fluorometer.
  • The assay was validated for GMP/Good Laboratory Practice (GLP) compliance.

Main Results:

  • The assay demonstrated high sensitivity, detecting killing at 60 pg/mL of GP101.
  • Over 90% of target B cells were killed within two hours in vitro.
  • The assay is suitable for purified GP101, cell-expressed GP101, and bioactivity in blood.

Conclusions:

  • A novel, validated GMP potency assay for GP101 was successfully developed.
  • The assay provides a reproducible and quantifiable measure of efficacy for GP101.
  • This assay platform may be adaptable for other bispecific T-cell engagers and diabody potency assays.