De-Risking LNP & RNA-Based In Vivo CAR-T Therapies
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The next generation of CAR-T therapy is moving in vivo, utilizing Lipid Nanoparticles (LNPs) and mRNA to engineer immune cells directly inside the patient. While this approach promises to democratize access to cell therapy, it introduces a unique set of bioanalytical challenges—from tracking transient mRNA expression to monitoring innate immune activation.
Accelevir supports LNP and RNA-based developers with a comprehensive suite of molecular and immunology assays designed to de-risk these novel modalities.
1. Tracking mRNA Persistence & Biodistribution
Unlike permanent DNA integration, mRNA cargo is transient. Proving how long it persists and where it distributes is critical.
We utilize ultra-sensitive RNA biodistribution assays (ddPCR/qPCR) to track LNP-RNA stability and clearance in plasma and tissue. This data is essential for establishing PK-like kinetics and confirming that your payload is reaching the target cells (e.g., T-cells, macrophages) while clearing from non-target organs.
2. Immunogenicity: ADA & Lipid Responses
LNP-encapsulated therapies can elicit immune responses against both the cargo (the CAR protein) and the delivery vehicle (PEGylated lipids).
Our tiered immunogenicity testing services include:
- ADA Assays: Detecting antibodies against the CAR transgene product.
- Anti-PEG/Anti-Lipid Assays: Monitoring immune responses to the LNP shell, which can accelerate clearance and reduce efficacy upon repeat dosing.
- Neutralizing Antibody (nAb) Assays: Confirming if the immune response inhibits the therapeutic function.
3. Cytokine Profiling & Innate Immune Activation
LNPs can sometimes trigger an innate immune response or “cytokine storm.” To monitor safety, we employ multiplex cytokine profiling using MSD and Luminex platforms.
We screen for inflammatory signatures (e.g., IL-6, TNF-α, IFN-γ) to characterize the acute response post-infusion. This data helps developers define safety margins and optimize LNP formulations for clinical use.
Accelerating Translation to the Clinic
From preclinical data packages to IND-enabling studies, Accelevir provides the specialized analytics required for LNP-RNA programs. Our integrated workflow combines molecular quantitation with deep immune monitoring to give you a holistic view of your product’s performance.
Ready to advance your in vivo program? Start your project with Accelevir.