Manufacturing, QC, and Patient Monitoring

Stages Of Immunotherapy Development

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Immunotherapy has led to significant advances in our understanding and treatment of cancer. However, there is more work to be done since cancer continues to affect millions of individuals worldwide. Explore the stages of cancer immunotherapy development and discover tools that assist you with your discovery at every stage.

Manufacturing, QC, and Patient Monitoring

When regulatory agencies approve a therapy, commercial scale manufacturing begins. To comply with rigorous standards for patient care, manufacturers need to continuously monitor their processes. Additionally, continuous patient monitoring ensures patient safety and guides the dissemination of appropriate treatment plans.

Key Tools for Manufacturing, QC and Patient Monitoring

Bio-Rad's extensive resin portfolio covers a range of chromatographic techniques and offers unique resin chemistries that can improve your purification process efficiency and costs. Our host cell protein workflow validates your host cell detection ELISA antibody coverage and ensures the integrity of your assay. Measure nucleic acid impurities in your final product with our ddPCR residual DNA assay; a sensitive, absolute, method for nucleic acid quantitation without needing a standard curve. To support QC and patient monitoring for cell therapies, ddPCR technology can determine CAR gene copy number in CAR T-cell therapies preparations prior to patient administration as well as to monitor patient levels during treatment.

Companion Products

  • Droplet Digital™ PCR (ddPCR™) Systems, Primers, Assays, and Arrays

    Droplet Digital PCR (ddPCR) Systems, Reagents and Assays

    • Perform QC testing prior to lot release of CAR T-Cell product, such as quantification of CAR genes and vector genome titres
    • Obtain precise quantification of residual DNA from host cells, to meet guidelines set by the World Health Organization, U.S. Food and Drug Administration or other regulatory agencies for release of final product
    • Characterize nucliec acid levels with sensitive and absolute quantiation using ddPCR
    • Confirm the CNV for cell therapies (CAR T) with more precision vs other methods
  • Single Cell Sequencing

    ddSEQ Single Cell Isolator

    • Perform B Cell and T Cell subunit functional analyses
    • Supports tumor profiling for patient stratification
  • CFX Real-Time PCR Detection System

    CFX Real-Time PCR Detection System

    • A low-cost, high-throughput means of screening and quantifying host-cell DNA
    • Broad dynamic range and high sensitivity makes qPCR a versatile method for DNA quantification
    • Precise quantification and multiplex target discrimination with 2–5 color multiplexing
  • Ze5™ Cell Analyzer

    ZE5 Cell Analyzer

    • Perform QC of cell therpaies during manufacturing using multi-parameter cell analysis
    • Monitor up to 30 parameters simultaneously, using up to 5 lasers, to identify cell subtypes faster and with more precision
    • Enables post treatment monitoring of patient immune cells and cell therapy levels in vivo
  • Host Cell Protein Analysis

    Host Cell Protein Analysis

    • Validate HCP ELISA antibody coverage according to ICH Q6B guidelines
    • Complete solution from 2D Electrophoresis to, Western Blotting and imaging
    • 21 CFR Compliant software and IQ/OQ/PQ Kits available
  • GS900

    GS900 Calibrated Densitometer

    • Self-calibrating densitometer to reproducibly quantitate proteins from gels, blots, and film
    • For cGMP with software for 21 CFR 11 compliant software and IQ/OQ Kit
  • Chromatography Resins

    Chromatography Resins

    • Range of chromatographic resins to improve your purification efficiencies
    • Resins with unique chemistries to offer more purification process options
    • Resins to purify non-traditional drug formats such as antibody fragments, ADCs, bi-specific antibodies
  • Bio-Plex System

    Bio-Plex Multiplex Immunoassay System

    • Generate data for targets of interest using off-the-shelf or custom assay solutions
    • Monitor analytes related to Cytokine Release Syndrome and other immune-ralated off-target effects with validated, quality panels
    • Gain confidence in your results with high-quality, reproducible, sensitive assays that can be used in multi-year studies
  • HuCAL Custom Monoclonal Antibodies

    HuCAL Custom Monoclonal Antibodies

    • Custom antibody development and production within 8 weeks
    • Antibodies developed for Flow, ELISA, IHC/ICC, Western Blot, co-crystallization and affinity chromatography assays used during QC processes
    • Highly specific, high affinity, animal free, recombinant monoclonal antibody with long term availability