CST Announces Availability of GMP-Grade CAR Linker Antibodies for CAR-T Cell Enrichment and Detection in Clinical Manufacturing and QC

Danvers, MA, USA, October 7, 2026–Cell Signaling Technology (CST), a life science discovery technology company and leading provider of antibodies, kits, and services, today announced the availability for purchase of GMP-grade recombinant monoclonal antibody conjugates targeting the G4S linker of scFv-based chimeric antigen receptors (CARs) for CAR-T cell enrichment and detection in cell therapy manufacturing and quality control (QC) workflows. The reagents are designed to simplify enrichment of CAR+ cells during manufacturing and increase productivity for in-process QC and lot-release assays.

“Linker-directed CAR detection and enrichment is becoming an essential part of building a scalable, platform-ready manufacturing process for cell therapies,” said CST Chief Operating Officer Craig M. Thompson, PhD. “A GMP-grade G4S linker antibody that can be used from pre-clinical CAR cell characterization through to clinical manufacturing and QC helps address a key pain point by making it easier to standardize across different CAR programs, instruments, and sites.”

Universal Tools to Enable CAR Workflows from Development to QC

CST’s industry-first anti-CAR linker monoclonal antibodies transformed pre-clinical CAR cell characterization by targeting the G4S or Whitlow/218 linkers commonly used in scFv-based CARs, allowing scientists to monitor diverse CAR constructs with a single reagent. The new GMP-grade G4S linker monoclonal antibody conjugates extend this capability into manufacturing and analytical QC, providing common reagents, that, with appropriate regulatory authorizations, could be used from development through clinical manufacturing. Using the same reagents across preclinical and GMP environments can simplify technology transfer, reduce method requalification, and support more consistent assay performance over time.

• CAR+ Cell Enrichment in Manufacturing (Now available to order): The G4S Linker (E7O2V) Rabbit Monoclonal Antibody (Biotin Conjugate) (GMP-Grade) #22985 is designed to enrich engineered CAR-positive (CAR+) cells containing multiple G4S repeats. By standardizing the percentage of pre-infusion CAR‑positive cells, the biotin conjugate could help mitigate challenges associated with low transduction efficiency.
• CAR+ Cell Detection for Analytical QC (Now available to order): The G4S Linker (E7O2V) Rabbit Monoclonal Antibody (PE Conjugate) (GMP-Grade) #22996 enables sensitive and specific detection of engineered CAR-positive cells containing multiple G4S repeats in flow cytometry, supports FACS‑based enrichment, and integrates directly into existing analytical QC workflows for in‑process and lot‑release testing.

Both the biotin- and PE-conjugated GMP-grade antibodies are compatible with a wide range of instruments and workflows, including magnetic bead‑based platforms, flow cytometers, and FACS systems, enabling flexible integration into existing processes.

Supporting GMP-Compliance, Productivity, and Supply Continuity

The G4S linker monoclonal antibody conjugates are designed and manufactured to GMP standards, and are supported by comprehensive documentation, including GMP manufacturing records, drug master files, chain‑of‑custody traceability, and quality system details to facilitate regulatory submissions for use as critical or ancillary materials in cell therapy manufacturing. Recombinant monoclonal antibody production from a well-characterized, clonal Master Cell Bank ensures lot-to-lot consistency and secure, long-term supply to support clinical‑stage programs.

“Pre‑conjugated, GMP‑grade CAR linker antibodies simplify manufacturing and QC workflows by reducing complexity with a single, fully traceable reagent,” said CST Chief Scientific Officer Roberto Polakiewicz, PhD. “When preclinical and manufacturing teams use the same well-documented products, they remove a major source of variability and reinforce overall GMP compliance. Our goal is to help cell therapy developers optimize their products and processes while reducing risk—so they can focus on advancing therapies, not overcoming regulatory hurdles.”

Visit cellsignal.com/CAR-T-GMP to review product information and request a custom quote, technical consultation, or the GMP documentation package.

Important:

The GMP-grade reagents are not intended for diagnostic use or direct administration into humans or animals. See the full Limited Uses statement at cellsignal.com/gmp-limited-uses

GMP-Grade Reagents:

The GMP-grade products were manufactured in compliance with regulatory requirements for current Good Manufacturing Practices (cGMP) including 21 C.F.R. Parts 11, 210, 211, 600, and the European Commission Directives 2001/83/EC, as amended, and the European Commission Guidelines of Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 2003/94/EC (Eudralex–Volume1 and 4, Annex 1, Annex 2). Additionally, the products were manufactured to comply with Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing U.S. FDA March 2001, EP chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-Based and Gene Therapy Medicinal Products, and USP <1043> Ancillary Materials for Cell, Gene, and Tissue Engineered Products. The final products are stored and maintained in a GMP compliant facility and shipped under Good Distribution Practice (GDP) conditions.

About Cell Signaling Technology

Cell Signaling Technology (CST) is a different kind of life science company—one founded, owned, and run by active research scientists, with the highest standards of product and service quality, technological innovation, and scientific rigor. Founded in 1999 and headquartered in Danvers, Massachusetts, USA, CST employs over 600 people worldwide. We consistently provide fellow scientists around the globe with best-in-class products and services to fuel their quests for discovery. CST is a company of caring people driven by a devotion to facilitating good science—a company committed to doing the right thing for our customers, our communities, and our planet. cellsignal.com

CST Contact

CST Media and Press
Rebecca J. Reppucci, MBA
Cell Signaling Technology
Senior Director, Global Marketing Communications
Phone: +1-978-880-3334
Email: marketingpr@cellsignal.com