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Regulatory Considerations For The Next Wave Of Gene Therapies
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The evolving field of viral vector production, driven by advances in gene and cell therapies, faces increasing regulatory scrutiny and analytical demands, requiring robust quality control, scalable manufacturing solutions, and strategic partnerships to ensure compliance and efficiency.
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Recombinant adeno-associated virus (AAV) has emerged as a leading modality for in vivo gene therapy. Development teams at MilliporeSigma have established an innovative approach to upstream optimization for these therapeutics, demonstrated via high-throughput methods for transfection optimization and scale-up of an optimized process to bench-scale bioreactors.
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Comprehensive AAV Express Platform For Streamlined Production
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Designed to streamline and de-risk recombinant adeno-associated virus (AAV) manufacturing for gene therapies, this comprehensive platform offers a scalable, cost-effective, and high-performing solution for preclinical development through GMP production of AAV.
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Analytics You Need To Boost Quality, Cut Risk, And Improve Efficacy
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Discover how you can enhance quality, de-risk production, and improve clinical trial outcomes of AAV-based gene therapies with advanced orthogonal methods for analytical testing. Learn how incorporating AEX-HPLC and NGS methods into analytical workflow led to having an array of orthogonal methods to improve AAV characterization, purity and quality. Don't miss this opportunity to gain valuable insights that can enhance your AAV-based gene therapy manufacturing processes and get your project from clinical to commercial success. Watch webinar.
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