Cell Therapy Testing

Our advanced understanding of biology and introduction of new technologies is empowering the development of human cellular products as therapy. This is especially true for the field of oncology, where we’ve made significant progress in the treatment of blood cancers with chimeric antigen receptor T cell (CAR-T) therapies and other advanced medicines. Research continues to expand the application of cellular therapies like CAR-T and others to target solid tumors.

Whether they are autologous (i.e., using the patient’s own cells) or allogeneic (i.e., using donor cells), the unique attributes of these therapies require thoughtful, therapy-specific programs to bring them to the clinic. Partnering with an organization that offers expertise in oncology from in vitro and in vivo assessments through safety testing can help you to achieve considerable cost and time savings on the road to clinic.


The Right Tools to Optimize Cell Therapies for Oncology

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The global market for cell therapies shows no sign of slowing down. Learn the essential steps to progress your CAR-T cell therapy to market in this on-demand webinar.
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With a truly integrated approach to oncology cellular therapy development that leverages our portfolio of human cellular products, research models, and cellular therapy testing , our team can customize a program of pharmacology and safety studies that meets the needs of your CAR-T, gene-based, and cellular oncology therapies. We’ll help you navigate a complex regulatory landscape, collect decision-driving data, and conduct even the most specialized studies to expedite your path through development.

 

Choosing the Right Cell Therapy Model

There is no single animal model that replicates the full spectrum of complexities and toxicities faced in clinical testing of CAR-T cells and other cellular therapies; however, models can provide important insights into the correlative effects of preconditioning, CAR-T cell dose, tumor burden, signaling potency, and, in some instances, identified target antigen specificities associated with toxicity events.

In Vivo CAR-T Cell Therapy Testing

Diagram showcasing the in vivo models available for cell therapy testing, including systemic, orthotopic, subcutaneous, and PDX models.
Figure 1. Diagram showcasing the in vivo CAR-T cell therapy testing models. Alt Tag: Diagram showcasing the in vivo models available for cell therapy testing, including systemic, orthotopic, subcutaneous, and PDX models.

Choosing the best animal model and optimizing the study design is critical to evaluating the effectiveness and safety profile of the product. Our in vivo CAR-T cell therapy testing models are available for xenograft, humanized, syngeneic, and transgenic settings.

It’s important to use appropriate animal models that demonstrate product activity and on-target/off-target effects as much as possible. Our established assays and models illuminate CAR-T biology, and we can personally guide you through this process.

 

CAR-T Toxicity Mechanisms and Considerations

Cellular therapies can have a wide spectrum of on-target and off-target mechanisms that contribute to toxicity; it’s critical to understand these and mitigate risks before progressing to the clinic. In vivo CAR-T cell therapy testing helps reduce those risks for faster entrance to the clinic.

  • On-target/on-tumor toxicity
    • Pharmacology is predictable
    • Cytokine release syndrome
    • Tumor lysis syndrome
  • On-target/off-tumor toxicity
    • Pharmacology undesirable
    • Hematological tumors, B cell aplasia
    • Solid tumors, ERBB2, CAIX, MAGE
  • Off-target toxicities
    • Myeloid activation, elevated Th2 cytokines
    • Neurotoxicity
    • Genotoxicity, insertional mutagenesis
    • Anaphylaxis, immunogenicity
    • Graft-versus-host disease (GvHD)

Using established tools and rationales to incorporate toxicity assessments in chosen in vivo CAR-T cell therapy models can characterize risk and inform clinical trial designs.

 

Regulatory Guidelines for Cell Therapy Products

There is no standardized preclinical testing paradigm. Each therapy is evaluated on product-specific characteristics, so understanding regulatory guidelines is key. In an integrated approach to your oncology project, we can run safety assessments alongside our in vivo pharmacology assessments. This allows us to use preclinical data to identify translational gaps and employ safety endpoints in clinical trials to mitigate potential risks.


Avoid Potential Pitfalls in Preclinical Study Design for Cell & Gene Therapies

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Drs. Shawna Jackman and Lauren Black discuss the special considerations and critical elements of a preclinical program strategy in the cell and gene therapy space.
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Let us guide the progression of your cellular therapy from discovery to the clinic; we can aid with CAR-T discovery, in vitro testing through to in vivo and safety assessment.

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Frequently Asked Questions (FAQs) about In Vivo CAR-T Cell Therapy Testing