GMP-Grade Recombinant Monoclonal Antibody Conjugates for Cell Therapy Manufacturing & QC

Incorporate robust, flexible CAR-T Cell Enrichment and Detection into Your Manufacturing and QC Workflows

CST transformed preclinical CAR cell characterization with universal recombinant monoclonal antibodies specific to the ubiquitous Whitlow/218 and G4S linker sequences of scFv-based CARs. This innovation enabled scientists to use a single reagent for a variety of assays without the time or cost of developing anti-idiotype antibodies for every CAR construct.

These trusted antibody conjugates, now manufactured to be GMP-grade, are intended to simplify enrichment of G4S linker CAR+ cells and increase productivity for in-process QC and lot release assays. In addition, production from a clonal Master Cell Bank minimizes lot-to-lot variability.

When preclinical development teams use the same reagents, handoffs can be that much easier as programs advance to later stages.

CAR+ Cell Enrichment in Manufacturing

Available Now: GMP-Grade G4S Linker (E7O2V) Rabbit Monoclonal Antibody (Biotin Conjugate) #22985 Enrich CAR+ cells containing multiple G4S repeats with one reagent Biotin-conjugated antibodies are amenable to magnetic bead-based CAR-T cell enrichment on cell therapy manufacturing instrumentation Standardize percent CAR-positive cells and mitigate issues associated with low transduction efficiencies Reagents are designed and manufactured to GMP-grade reagent standards* Clonal Master Cell Bank ensures lot-to-lot consistency

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CAR+ Cell Detection for Analytical QC

Available Now: GMP-Grade G4S Linker (E7O2V) Rabbit Monoclonal Antibody (PE Conjugate) #22996 Detect CAR+ cells containing multiple G4S repeats with one reagent Simplify in-process QC and lot release assays PE-conjugated antibodies plug into your existing analytical flow cytometry panels Amenable to CAR+ cell detection in flow cytometry and FACS-based enrichment Reagents are designed and manufactured to GMP-grade reagent standards* Clonal Master Cell Bank ensures lot-to-lot consistency

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	Seamless Transfer from Preclinical to Clinical
Achieve smoother handoffs when the same GMP-grade reagents are used in preclinical development as in manufacturing and QC Save time qualifying reagents for advanced process development

	Reagent Security and Supply Continuity
The products follow a GMP-compliant process, with required documentation and a controlled chain-of-custody to ensure traceability Recombinant monoclonal antibodies are produced from a clonal Master Cell Bank to ensure lot-to-lot consistency

Translational-Grade Recombinant Monoclonal Antibody Conjugates for Cell Therapy Manufacturing & QC Process Development

	CAR+ Cell Enrichment Process Development
G4S Linker (E7O2V) Rabbit Monoclonal Antibody (Biotin Conjugate) (Translational-Grade) #80462

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	CAR+ Cell Detection for Analytical QC Process Development
G4S Linker (E7O2V) Rabbit Monoclonal Antibody (PE Conjugate) (Translational-Grade) #99539

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• Ideal for process development; a clear upgrade path to GMP-grade when needed
• Made in the same GMP-certified laboratory as GMP-grade conjugates, using the same processes
• Identical formulation and concentration with equivalent performance to GMP-grade conjugates
• Volume options make ordering the right size easy
• Extended documentation to support audit requirements
• Available globally, with fast shipping
• The translational-grade reagents are for Research Use Only (RUO) and not for use in manufacturing or quality control of commercial drug products or diagnostic procedures.

Important: The GMP-grade reagents are not intended for diagnostic use or direct administration into humans or animals. See the full Limited Uses statement here.

*_{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.}