Research Project
9771767
Project(Summary( ! The!very!forces!critical!to!creating!the!three-dimensional!structure!of!proteins!are! also!responsible!for!unwanted!and!often!dangerous!protein!aggregates!in!protein- based!therapeutics.!Protein!aggregation!occurs!at!every!stage!in!the!pipeline,!from! development,!formulation,!and!manufacturing!to!shipping,!storage!and!point!of!use.! The!FDA!advised!in!its!2014!Guidance!for!Industry!that!``It!is!critical!for! manufacturers!of!therapeutic!protein!products!to!minimize!protein!aggregation!to! the!extent!possible'',!while!acknowledging!that!technology!does!not!currently!exist! to!accomplish!this!goal,!particularly!in!the!critical!sub-visible!range!from!100!nm!to! 10!microns.!Thus,!there!is!a!pressing!and!unmet!need!for!instrumentation!that!can! assess!the!size!distribution!and!morphology!of!protein!aggregates!in!this!size!range.!! The!parent!SBIR!Phase!II!program!is!meeting!this!need!by!developing!an!instrument! that!uses!holographic!video!microscopy!to!characterize!protein!aggregates!rapidly! and!reliably!enough!for!in-line!monitoring!of!pharmaceutical!formulations.!The! Phase!II!work!is!harnessing!patented!capabilities!for!automated!high-throughput! measurement!of!real-world!samples.!Hardware!and!software!innovations!will! ensure!accuracy!and!efficacy!in!high-speed!characterization,!and!to!further!increase! the!sophistication!and!reliability!of!particle!differentiation!even!when!different! components!are!the!same!size.!This!program!will!also!elucidate!the!influence!of! increased!flow!speed!on!protein!aggregation.!Holographic!characterization!of! protein!aggregation!will!provide!detailed!data!needed!for!product!development,! process!control!and!quality!assurance!in!the!biologics!industry!resulting!in! increased!efficiency,!safety!and!cost!savings!in!this!rapidly!growing!field.!!The! diversity!candidates!will!participate!in!this!invention!and!discovery!process! providing!them!with!critical!training!and!experience!at!this!important!stage!in!their! careers.! ! ! ! ! ! !
