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Category: Cell and Gene Therapy

The Role of ddPCR in Clinical Trials: Precision Quantitation for Gene Therapy

The Role of ddPCR in Clinical Trials: Precision Quantitation for Gene Therapy

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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How Do You Overcome Bioanalytical Challenges in Cell & Gene Therapy Development?

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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