Instrument for Holographic Characterization of Protein Aggregates - This SBIR Phase II program is developing an instrument that uses holographic video microscopy to meet quality needs for biologics.

The very forces critical to creating the three dimensional structure of proteins are alsoresponsible for unwanted and often dangerous protein aggregates in proteinbased therapeuticsProtein aggregation occurs at every stage in the pipelinefrom developmentformulationandmanufacturing to shippingstorage and point of useThe FDA advised in itsGuidance forIndustry that ``It is critical for manufacturers of therapeutic protein products to minimizeprotein aggregation to the extent possibleandapos andaposwhile acknowledging that technology does notcurrently exist to accomplish this goalparticularly in the critical sub visible range fromnmtomicronsThusthere is a pressing and unmet need for instrumentation that can assess thesize distribution and morphology of protein aggregates in this size rangeThe parent SBIR Phase IIprogram is meeting this need by developing an instrument that uses holographic video microscopy tocharacterize protein aggregates rapidly and reliably enough for in line monitoring ofpharmaceutical formulationsThe Phase II work is harnessing patented capabilities for automatedhigh throughput measurement of real world samplesHardware and software innovations will ensureaccuracy and efficacy in high speed characterizationand to further increase the sophisticationand reliability of particle differentiation even when different components are the same sizeThisprogram will also elucidate the influence of increased flow speed on protein aggregationHolographic characterization of protein aggregation will provide detailed data needed for productdevelopmentprocess control and quality assurance in the biologics industry resulting in increasedefficiencysafety and cost savings in this rapidly growing fieldThe diversity candidates willparticipate in this invention and discovery process providing them with critical training andexperience at this important stage in their careers Project Narrative The tendency for proteins to aggregate is a critical barrier to developing and manufacturing biopharmaceuticals for targeting a wide array of diseaseslargely because there are no fasteffective and reliable methods to detect and characterize these clustersThis proposed SBIR Phase II program will develop an instrument that uses holographic video microscopy to meet this needresulting in increased efficiencysafetyand cost savings in the promising and rapidly growing area of protein based therapeuticsThe diversity candidates will participate in the modifications of holographic characterization of for use in the biopharmaceutical industry by simultaneously measuring the concentrations of similarly sized different componentsincluding protein aggregatesin real world sampleswith high throughput microfluidic sample handling