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Description
Liposomal drug products have been approved for clinical use, with one
third of the drug product submissions containing nanomaterials regulated by the
FDA constituting liposomal compositions. There is a gradual trend in increasing
generic product drug submissions containing liposomes with the emergence of new
products containing lipid nanoparticle formulations for vaccines and
therapeutic use. FDA published liposomal guidance and product
specific guidances to help industry and to facilitate product review. The critical quality attributes (CQAs) to
consider for these nanomaterials include size and shape heterogeneity, chemical
composition, purity of the ingredients, and the surface properties, along with
drug release and various stability parameters associated with these novel
products. A slight variation in the CQAs of nanomaterials may lead to
differential recognition by the immune system, pharmacokinetics of the drug,
which may lead to an altered biodistribution, efficacy, and safety. Consensus
standards through stakeholder involvement and collaboration can assist product
development, quality control and facilitate the review of submission to
FDA.
The purpose of this presentation is
to describe the standards development process from identifying which standards
need development that are most useful for industry and regulators, through the
standards development process including conducting interlaboratory studies for
precision and bias in the measurements.
Recent progress in the development of liposome standards, approved
standards, and the database of recognized consensus standards at FDA will be
presented
Learning Objectives:
- What are documentary standards
- The process of identifying, proposing, and development of these standards
- Standards recognition by regulators and how industry can utilize them in their submissions for review