End-to-End Cell Therapy Development: From Concept to IND

Yes. We provide a complete development process for novel targets. We start by using phage display libraries, hybridoma technology, or our proprietary Surfarray™ cell microarray technology to screen and discover high-affinity, high-specificity binders (e.g., scFv) for your target. After obtaining candidate binders, we perform affinity measurement and functional validation. Once the optimal binder is selected, our team immediately proceeds with CAR design and construction, and can integrate various optimization strategies (such as optimizing co-stimulatory domains or adding safety switches) before moving into the subsequent functional testing phase.

Upon project completion, we provide a full, detailed, and comprehensive study report. This report includes all experimental designs, raw data, analysis results, and conclusions, covering everything from CAR construction and in vitro functional validation to in vivo efficacy and safety assessments. For key IND-enabling studies (such as toxicology), we can perform them under GLP (Good Laboratory Practice) compliant conditions and provide reports in a format that meets regulatory requirements. Our goal is to deliver a high-quality, data-rich package to strongly support your Investigational New Drug (IND) application.

We provide a variety of clinically relevant animal models to support your preclinical studies. These include standard subcutaneous xenograft models, orthotopic models that better mimic the native tumor environment, and patient-derived xenograft (PDX) models that most accurately reflect patient tumor heterogeneity. The study endpoints are comprehensive and typically include: tumor growth inhibition (volume and weight), animal survival analysis, in vivo persistence and biodistribution of CAR-T cells, histopathological analysis of key organs for toxicity assessment, and monitoring for potential side effects such as Cytokine Release Syndrome (CRS).

Our policy is straightforward and client-centric: you retain full ownership of all intellectual property generated from your project. As a pure fee-for-service CRO, our business is built on providing expertise, not on claiming rights to your discoveries. This is formalized through robust legal agreements, beginning with a Confidentiality Disclosure Agreement (CDA). Subsequently, our Master Service Agreement (MSA) explicitly states that all foreground IP—including novel constructs, data, and protocols developed for your therapeutic—is your sole and exclusive property. We ensure a complete IP transfer, giving you the freedom to advance your candidate without future encumbrances from us.

Absolutely. While our end-to-end solution offers a seamlessly integrated and accelerated timeline, our services are entirely modular to offer maximum flexibility. We recognize clients have diverse needs at various stages, so you can engage us for a single, specific service or a custom-built package. For instance, you might only require our preclinical in vivo testing using specialized PDX models for an existing construct, or perhaps just our binder discovery services for a novel target. Our team will work closely with you to create a work plan that precisely fills the gaps in your program, allowing you to leverage our specialized expertise exactly where it's needed most.