Biopharmaceuticals Cmc Aspects

Summary

This new ISPE instructor-led course is an advanced level course on Chemistry, Manufacturing and Controls ( FDA discusses regulatory expectations for biotechnology products, regulatory challenges, and strategies for success. Presenters: ... Biologics & Biosimilars Regulatory In around 40 minutes, this webinar will cover: • Why developing biological/biotech/biosimilar products is so challenging • What ... Over 30 minutes, this webinar will investigate: • Impact of process changes for recombinant therapeutics • When are comparability ... This 30 minute webinar will examine the following: • Examining the major analytical and stability differences between small ... The complex structure of antibody-drug conjugates (ADCs), a sophisticated class of targeted therapeutics that combine the ... Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the ... This presentation examined regulatory definitions and requirements for drug substances and drug products in IND submissions. Maria Cecilia Tami and Balajee Shanmugam review the Chemistry, Manufacturing and Controls ( CDER's Maria Cecilia Tami and Chunchun Zhang discuss Presenter: Carmella S. Moody, PhD Regulatory Program Director RTI International rti.org Presenter Carmella S. Moody ...