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In a Phase 2 or Phase 3 trial, you might have twenty different clinical sites collecting blood. If Site A uses a different centrifuge speed than Site B, or if Site C leaves the blood on the bench for four hours longer than Site D, your downstream data will be incredibly noisy. Site-to-Site Variability is […]
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One of the most frustrating scenarios in bioanalytics is the “High Background” plate. You run a functional assay, and your negative control wells are full of non-specific activity. Is it the assay? Is it the reagents? More often than not, it is the cryopreservation protocol. Through our PBMC Processing & Functional Validation Services at Accelevir, […]
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In multi-center clinical trials, the standard logistics model involves collecting blood at the clinical site, shipping it overnight to a central lab, and processing it the next day (24+ hours post-draw). While convenient for logistics, this delay is detrimental to T-cell biology. Research published in the Journal of Immunological Methods consistently shows that granulocyte contamination […]
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At Accelevir, we focus on ultra-rare target detection and have become hyper-vigilant about incoming PBMC Quality which includes viability, recovery and Flow based immuno-profiling. As expected we find that PBMC quality is one of the most critical elements of end-point readouts and triage decisions for clinical trial design and outcome measurements. Sponsors frequently discover—too late—that […]
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In the development of biologics and advanced therapies, the industry has historically focused heavily on the humoral immune response. Screening for Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) is a standard path for regulatory approval. However, for developers of Gene Therapies (AAV, Lentivirus) and complex biologics, ADA data only tells half the story. As highlighted […]
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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, […]
Read MoreIn immuno-oncology and autoimmune drug development, knowing if a drug works is only half the battle. You also need to know how it is shaping the patient’s immune system. Is it expanding the right T-cell subsets? Is it triggering the intended functional activity? At Accelevir, we provide advanced immune response monitoring to answer these questions. […]
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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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