Clinical Trials

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.

Clinical Trials

During this stage, potential therapies are tested in human clinical trials involving a series of rigorous, regulated tests. In early phases of clinical research, healthy subjects are enrolled to test for safety of the selected therapy. In later phases, cancer patient's tumor type or subtypes are profiled, and the patient is matched to the most appropriate potential therapy. Efficacy and side effects of the therapeutic are closely monitored and recorded. Treatment may be halted at anytime if serious side effects are found. In parallel, manufacturing teams are scaling up production to be able to meet market needs should the therapeutic be approved.

Key Tools for Clinical Research

Patient safety can be assessed bytracking biomarkers using technologies such as the Bio-Plex Multiplex Immunoassays System that can measure up to 500 analytes simultaneously, including important immune and inflammation biomarkers. Some clinical teams may need to outsource development of essential assay reagents. Bio-Rad's HuCAL Custom Antibody service provides assay components in a continuous reliable supply within 6 weeks using an animal free platform. Patient tumor profiling is often used to ensure the appropriate therapies are given to the correct patient population. Droplet digital PCR (ddPCR) provides a simple, sensitive method to identify and measure genetic mutations in tumors from liquid biopsies. This technology can also be used to monitor residual disease in response to the potential therapy.

Companion Products

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

    Droplet Digital PCR (ddPCR) Systems, Primers, Reagents and Assays

    • Measure relevant biomarkers such as mutations, translocations, with high sensitivity and precision
    • Monitor minimum residual disease from limited amounts of starting material available from liquid biopsies
    • Obtain precise nucleic acid quantification from complex sample matrices such as FFPE
    • Obtain same day results from testing with fast workflow and simple data analysis
  • 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

    • High-performance PCR workflows support clinical gene expression assays
    • Powerful & flexible instruments with 2–5 color multiplexing to deliver sensitive, reliable detection of both single & multiplex RT-PCR reactions
    • Reagents optimized for your application including single cell GX, lncRNA, CNV, mutation & pathogen detection
  • Ze5™ Cell Analyzer

    ZE5 Cell Analyzer

    • Characterize patient derived cells and cell therapies during clinical studies 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
    • Fast acquisition rate allows rare or transient cell types to be readily analyzed
    • Clinical immune monitoring of the persistence and functionality of infused cell therapies
  • S3e Cell Sorter

    S3e Cell Sorter

    • Sort and analyze cells on your bench for cell based and downstream assays during clinical studies
    • Use up to 3 lasers to distinguish & sort subtly different cell populations
    • Sort cells quickly and gently while maintaining sensitivity and precision, supporting the sorting of fragile cell types
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  • ZOE™ Fluorescent Cell Imager

    ZOE Fluorescent Cell Imager

    • Quickly monitor cells at your bench prior to, during and after assays used in clinical research
    • Touch screen imaging software to view cells, capture images, and create multichannel merges
    • Flexible operation with brightfield and three fluorescence channels for routine and more sophisticated imaging applications
  • TC20™ Automated Cell Counter

    TC20 Automated Cell Counter

    • Quantify cells prior to, during and after cell based assays during clinical research to ensure reproducibility
    • Monitor cell health and accurately count cells in less than 30 seconds in one simple step without the need for manual counting
  • Antibodies

    Antibodies

    • A full range of off-the-shelf antibodies for cancer research including: PrecisionAb™ Validated Western Blotting Antibodies
    • Antibodies and reagents available to determine apoptosis, cell proliferation and viability, cell signaling, oncogenes and oncoproteins
    • Options available for ELISA, IHC, flow cytometry, and western blot
  • NGC and Fraction Collector

    Chromatography Resins & Columns

    • Bio-Rad resins can be used throughout scale up to commercial scale manufacturing
    • Choose from our large resin library including unique resin chemistries to improve your purification process
    • Resins designed to purify non-traditional drug formats such as antibody fragments, ADCs, bi-specific antibodies
  • NGC and Fraction Collector

    NGC Chromatography System and Fraction Collector

    • Flexible chromatography system with user-friendly, intuitive software to keep your lab running efficiently throughout translational research
    • Supports purification of biological drugs and key reagents for assays
    • Fraction collector works with plates, bottles and carboys to offer unrivaled flexibility in sample collection
  • NGC and Fraction Collector

    Anti-Idiotypic Antibodies

    • Evaluate dose, efficacy, and toxicity during PK and ADA testing
    • Designed for multiple assay formats including bridging and antigen capture assays
    • High quality standards to suport regulatory compliance 
  • Bio-Plex System

    Bio-Plex Multiplex Immunoassay System

    • Measure multiple proteins simultaneously to validate biomarkers and monitor therapeutic safety/efficacy/toxicology
    • Gain confidence in your results with high-quality, reproducible, sensitive assays that can be used in multi-year studies
    • Generate data for targets of interest using off-the-shelf or custom assay solutions
  • V3 Western Workflow

    V3 Western Workflow

    • A five-step Western Blotting protocol that simplifies protein normalization and quantitation providing faster results
    • Analyze expression of multiple protein targets with multiplex imaging - chemiluminescence, fluorescence, or colorimetric
    • 21CFR Part 11 Compliant software and IQ/OQ/PQ available
  • 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 clinical phases
    • Highly specific, high affinity, animal free, recombinant monoclonal antibody with long term availability