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This article describes biosimilarity assessment approach applicable to comparability of lifecycle assessments and compliant with the US FDA’s totality of evidence concept.
This eBook records an interview with Susan Dana Jones (Harpoon Therapeutics) about balancing speed to IND without leaving gaps in process understanding and scalability.
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At the CPhI Theater in May 2019, Courtney Morgret, PhD, senior scientist at ABBVIE, shared some key CMC considerations for antibody-drug conjugate products.
This article details a streamlined protocol for serum-free adaptation of CHO-DG44 cell lines from adherent, serum-supplemented culture to suspension culture in a fully defined chemical medium.
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In this special report ModiQuest Research applies Intellicyt® iQue technology in its hybridoma screening process. The iQue3 system expedites the discovery of antibodies through improved screening of antigen presentation during stable cell line generation, sera evaluation, and hybridoma selection.
