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By working to optimize variables such as plasmid and vector design, yield, analytical development, and production pathway early, and by prioritizing downstream considerations, drug developers can prevent issues and avoid the delays that can derail development.
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Inadequate preclinical process development can stall advanced therapy development, preventing patients in need from receiving treatment for life-threatening diseases. Leveraging the capabilities of an experienced partner is a key factor in optimizing AAV processes.
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Hear the extraordinary story of how one family, driven by urgency and guided by pioneering leaders in gene therapy, partnered with AAV experts to develop a treatment for their daughter’s ultra-rare neurodegenerative disorder, NEDAMSS, in just 14 months.
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Major hurdles of manufacturing AAV vectors are scalability, production yields, and clean feed-streams to facilitate effective purification strategies. Review the demands for AAV manufacturing using a suspension process and the DOE-based strategy.
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