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Final Product Release Testing

A safe and consistent cell therapy product requires stringent, sensitive, and standardized assays to document purity and quality. Our pioneering technologies allow you to generate reliable and accurate quality control data while ensuring your cell therapy gets to the clinic as fast and as safe as possible.

In-processing QC Testing

QC your cell therapy product with confidence and ease using our pioneering technologies. Our automated ELISA and particle detection instruments, along with our breadth of flow cytometry antibodies, are ushering in a new era of time-efficient and sensitive quality control assays.

Cell Characterization

Ella and Simple Plex™ Immunoassays

Ella is an automated ELISA platform from ProteinSimple that is ideal for in-process and release testing. Ella provides unparalleled accuracy, reproducibility, and speed for characterizing the cytokine secretion profile of your cell therapy product.

Learn More about Ella and Simple Plex Assays

Single, Multianalyte or Multiplex Assays on Automated ELISA System Ella
Cell and Gene Therapy

Flow Cytometry Antibodies

Marker expression and cell population purity are important release criteria for a cell therapy product. Make sure you use antibodies that perform consistently and have a stable supply.

Cell Therapy Product Purity

Verifying a contaminant-free cell therapy product is required for release to market. Micro-Flow Imaging™ (MFI) Systems from ProteinSimple are designed to make this accurate and easy. Use MFI to confirm the absence of sub-visible particles, such as magnetic beads and protein aggregates.

Learn more about MFI Systems

Micro-Flow Imaging (MFi) Particle Analysis Instrument by ProteinSimple

In Vivo Monitoring

Single, Multianalyte or Multiplex Assays on Automated ELISA System Ella

Sensitive and Quick Biomarker Analysis

Tracking the clinical safety and efficacy of a cell therapy requires sensitive and fast systems for monitoring the patient response. Ella and Simple Plex™ assays from ProteinSimple are making real-time monitoring of immune responses a reality.

Learn More about Ella and Simple Plex™ Assays

Simple Plex Application Data

Excessive release of pro-inflammatory cytokines such as IL-6, IFN-8, IL-10, GM-CSF and CRP, among others can be a toxic response to cell therapy. This poster shows the sensitivity and precision of using Simple Plex assays to monitor cytokine levels in blood of CAR T patients.

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Cell and Gene Therapy
Luminex Assay

Luminex® Assays

The multianalyte capabilities of Luminex assays are also ideal for monitoring the patient response to cell therapies. This quantitative platform can measure up to 50 analytes simultaneously, using a small sample volume, to provide a cost-effective method for biomarker monitoring.

Learn More about Luminex Assays and Instruments.

R&D Systems, a Bio-Techne Brand

Start at Discovery. Go to the Clinic.

Grow your research into a therapy with innovative tools and trusted reagents. Bio‑Techne is a full workflow provider from discovery to the clinic, including research-grade cell separation and phenotyping tools.

R&D Systems, a Bio-Techne Brand

Custom Solutions for Cell Therapy

Efficient workflows often require customized solutions. Put our decades of experience to work for you. View our portfolio of services for customizing your cell therapy manufacturing workflow.