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Accelerating the path from DNA to IND is fundamental to success in biologic development. To eliminate delays and build efficiency en route to the clinic, sponsors and their manufacturing partners are turning to new expression vector systems and robust pool material data.
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An integrated, platform-driven CMC approach can move your antibody program from DNA to IND in as little as six months. Discover how to accelerate development while reducing risk and maintaining quality and regulatory alignment.
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As demand grows for complex antibody-derived therapeutics, developers and CDMOs are racing to speed up IND and FIH studies. One proven approach: generating material for tox studies as quickly as possible to enable timely IND submissions and unlock additional funding.
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CHO cells remain the gold standard for manufacturing recombinant therapeutic proteins, but new variants can limit growth and quality. These Lonza case studies show how expertise and mitigation strategies overcome those hurdles to deliver efficiency and reproducibility.
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Poor manufacturability and immunogenicity can quietly derail a development timeline. Learn how early developability assessments surface these risks sooner and support IND readiness.
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