functional and predictive assays for biotherapeutics ...€¦ · 1hansel tt, et. al. nature reviews...
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Thrombocytopenia
Neutropenia
Our predictive assays help you assess
Functional and Predictive Assays
Cytokine release syndrome
Cytokine storm
Primarycell binding
Primary cellactivation
Targeted killing
Cell signaling
E�cacy and Toxicity
for Biotherapeutics Development
1Hansel TT, et. al. Nature Reviews Drug Discovery 9, 325 (2010)
Extensive biotherapeutic experience
About Us
Functional and Predictive Assays for Biotherapeutics Development
Many biotherapeutic developers use the services of ReachBio Research Labs as an important part of their biologic
development programs.
Take advantage of our experience, �exibility and research depth to tailor assays to suit your needs.
Our experience supporting biotherapeutic development includes assays to evaluate primary cell functionality and toxicity of
monoclonal antibodies, bi-speci�c antibodies, antibody-drug conjugates, nanobodies and other biologics.
We have extensive experience measuring the ability of biotherapeutics to bind to cells and trigger complement-dependent
cytotoxicity, antibody-dependent cytotoxicity and T cell-mediated cytotoxicity.
Frequently observed side e�ects of biotherapeutics include thrombocytopenia, neutropenia and severe anemia.1
We have proven and predictive primary cell-based assays to address each of these issues.
Ranking toxicity of lead biotherapeutics to predict clinical thrombocytopenia, neutropenia and severe anemia
Evaluating bi-speci�c immunotherapies for the ability to recruit immune cells to kill cancer cells
Assessing biotherapeutics’ e�ects on cancer stem cells
Customizing cell biology assays to �t client needs
Helping support INDs and Phase 1 clinical trials
Primary cell biology experts
© ReachBio LLC. All rights reserved.
• Primary blood and bone marrow cell culture from multiple species
• Primary blood cancer stem cell culture from multiple donors
• Immunotherapy evaluation using primary immune cells and cancer cells
• Cell bank production of expanded primary cells
• Blood progenitor (normal and cancer) cell culture
• Flow cytometry (up to 16 color)
• Coming soon: CyTOF Mass Cytometry!
• Small animal and NHP dosing models (performed with collaborators)
• Luminex® and intracellular cytokine analysis
• Coming soon: Genomic analysis!
Evaluate and rank your biotherapeutic candidates for their risk of clinical thrombocytopenia, neutropenia or severe anemia
• Applicable for evaluation of both biologics and small molecules
• Predictive of clinical thrombocytopenia, neutropenia or severe anemia
• Evaluate molecules alone or in combination with standard-of-care drugs
• Customized to your program’s needs
Blood and bone marrow toxicity assays
Evaluate and rank the e�ectiveness of your biotherapeutic candidates at inhibiting cancer stem- and progenitor - cell expansion
Cancer stem cell assays
• Applicable to both biologics and small molecules
• Measure functional inhibition of cancer progenitor cell expansion
• Customized to your program’s needs
• Evaluate therapies that target cell surface receptors (e.g. CD24) and stem cell-associated signaling pathways (e.g. Wnt/Hedgedhog)
Correlation of in vitro CFC IC50 values with clinical neutropenia
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Evaluate and rank the ability of your candidates to recruit T cells and NK cells to kill cancer cells
Cancer immunotherapy assays
• Compatible with bi-speci�c antibodies and other immune cell recruiters
• Measure primary immune cell killing of target cells
• Flow cytometry based readout with additional intracellular analysis, if desired
• Customized to your program’s needs
Functional and Predictive Assays for Biotherapeutics Development
Cytokine storm and cytokine release syndrome (CRS)
• Human cells are more relevant at predicting risk of cytokine storms or CRS than are in vivo primate models due to nuanced immunological differences between the species
• Human primary cell-based assays with pro-inflammatory cytokine quantification using the Luminex® platform
• Uses the soluble, not plastic-immobilized form of the biologic
• Helps to understand the risk of non-specific immune cell activation prior to NHP studies
Evaluate and rank the potential risk of your candidates to induce cytokine release or cytokine storms with our in vitro assays
ReachBio LLC. All rights reserved.®©
Luminex is a registered trade mark of Luminex Corporation
Therap.Ab(pg/mL)
100,000
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5,000
1,000
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10
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1:2 1:1 5:1 10:1E:T Ratio