CFSE T Cell Proliferation vs. Intracellular Cytokine Staining
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Choosing the right functional T cell response assay for your program?
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Choosing the right functional T cell response assay for your program?
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A scientific guide to the five application domains where ddPCR is not simply the better analytical choice — it is the only defensible platform. With peer-reviewed evidence, detection limit comparisons, regulatory context, and expert consensus for cell & gene therapy, oncology liquid biopsy, and infectious disease programs.
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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.
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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?
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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).
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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.
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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.
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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?
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Accelerating AAV, Lentiviral, and mRNA Programs from Discovery to the Clinic.
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?
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