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Novel analytical technologies like Droplet Digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for therapeutic development that better aligns with the industry need for better sensitivity, accuracy, and precision. This relatively new form of PCR offers distinct advantages for DNA and RNA quantification.
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Recent years have proved challenging for the viral gene therapy community. Drug developers report difficulties securing adequate funding for a full program and the need to adapt to more conservative funding packages. As a result, sponsors may opt to outsource construct design through Phase 1 to experienced CDMOs.
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FUJIFILM Bio Science & Engineering Laboratories (BSEL) has developed a novel continuous electroporation system that combines high-density cell culture with high-throughput continuous transfection. The development work involved optimizing high-density cell culture and developing a scalable continuous electroporation instrument.
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To meet the demands of the early phase market, flexible viral vector drug candidate screening and feasibility studies can help to quickly overcome preclinical and Phase 1 hurdles. This presentation focuses on a strategic, effective approach for early stage development and how it can propel therapies to the clinic and the market.
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Collaboration between sponsor and CDMO is a critical component to ensuring successful viral vector manufacturing. As you consider your proposed milestones, budget restrictions, and product quality aspects, let the expertise of your manufacturer and the FDA guide your path for getting therapies to patients as soon as possible.
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Can the expedited approach used for COVID-19 be replicated to develop curative therapies for rare diseases? This webinar shares a thorough investigation that delves into the crucial factors for speeding up the development of curative therapies, highlighting the strategic contribution CDMOs can make in this groundbreaking process.
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