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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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For developers of biologics, cell therapies, and vaccines, “How immunogenic is my drug?” is one of the most critical questions in the development pipeline. An unwanted immune response can compromise safety, alter pharmacokinetics, and neutralize therapeutic efficacy. Answering this question requires more than a single assay. It demands a comprehensive lifecycle approach that looks beyond […]
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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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The success of a clinical trial hinges on the quality and integrity of its data. Every sample, every assay, and every result informs critical decisions that impact timelines, budgets, and ultimately, regulatory approval. At the heart of this complex process lies a pivotal decision: choosing the right central lab. Selecting a central lab is more […]
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In the development of biologic drugs—from monoclonal antibodies to gene therapies—few challenges are as critical and complex as understanding immunogenicity. The potential for a therapeutic to elicit an unwanted immune response in patients can profoundly impact its safety and efficacy. For drug developers, a robust immunogenicity testing strategy is not just a regulatory requirement; it’s […]
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