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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 […]
Read MoreIPDA™ HIV-1 IPDA™ SIV IPDA™ SHIV Total HIV-1 DNA qPCR HIV-1 Cell-associated RNA PCR QVOA (Quantitative Viral Outgrowth Assay) HIV-1 Bulk Outgrowth HIV-1 SCA (Single Copy Assay) HIV-1 HIV-1 Viral Load
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