Connect Conference & Show Floor Educational Sessions

View, browse and sort the list of Connect Conference sessions and show floor programming by pass type, track, and format. Please note, all Connect Conference delegates have access to CPhI Connect and InformEx Connect programming. Seating is first come, first serve, so please arrive early to sessions that you would like to attend. Sessions are subject to change.

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  • Nanoparticle Drug Delivery Systems: Trends and Challenges to Routine and "Appropriate" Nanomaterial Characterization

    Keynote:
    • Fred Klaessig  |  Manager, Pennsylvania Bio Nano Systems, LLC
    Location:  113AB
    Vault Recording: TBD

    The number of nanoparticle/nanomaterial based drug product submissions has been steadily increasing and is matched by an evolution in the FDA's questions and understanding of these complex materials. Physico-chemical characterization is becoming prominent in linking the drug formulation both to its safety & efficacy results as well as to the critical quality attributes that will be controlled during manufacture or used in specifying ingredients. There is a similar realization in chemical registration that a fuller understanding of nanoparticle toxicity requires aligning modifications to harmonized OECD test guidelines to those physico-chemical attributes that influence the mode of action. In both cases, additional characterization parameters and new test methods, abiotic and biological, are likely.