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In the early days of Cell Therapy, “Identity” was the primary bioanalytical hurdle. If you were manufacturing a CAR-T therapy, the main question was: Are these cells CD3+? Are they expressing the CAR? As the industry matures and regulatory scrutiny intensifies, the bar has shifted. The FDA’s Guidance on Potency Tests for Cellular and Gene […]
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Accelerating AAV, Lentiviral, and mRNA Programs from Discovery to the Clinic. Developing cell and gene therapies requires more than standard lab services; it demands a bioanalytical partner who understands the unique behavior of viral vectors and engineered cells in vivo. Accelevir provides a comprehensive suite of molecular and immunology assays designed to characterize your product, […]
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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 […]
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In the rapidly evolving landscape of cell and gene therapy, the margin for error is non-existent. As therapies move from preclinical models to human clinical trials, the need for absolute quantification of genetic material becomes critical. Traditional qPCR, while useful, often lacks the sensitivity and precision required for the complex matrices and low-abundance targets found […]
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Developing cell and gene therapies (CGT) requires navigating a complex landscape of analytical challenges. Whether you are working with AAV, lentivirus, mRNA therapeutics, or novel vectors, the questions you must answer to satisfy regulatory bodies are rigorous. How does the product distribute, persist, or express in target and non-target tissues? How do you analytically characterize […]
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