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Instrument for Holographic Characterization of Protein Aggregates

Award Number: R44TR001590
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2016
PERIOD OF PERFORMANCE END DATE: 12/31/2022

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Instrument for Holographic Characterization of Protein Aggregates - 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 based on holographic video microscopy (HVM) to detect and count protein aggregates rapidly and reliably enough for monitoring pharmaceutical formulations. Results from the Phase II work has resulted in sales of instruments to major pharmaceutical companies and universities. Early adopters and prospective customers have identified key additional capabilities that would enable them to deploy this technique at all stages of their process from formulation development and metrology into quality assessment and manufacturing process control where Spheryx’s technology has the potential to improve product quality and reduce manufacturing costs. This Phase IIB work will extend Spheryx’s capabilities to meet their needs. The specific aims of this work are: (1) detect and distinguish contaminants currently challenging biologics manufacturing including air bubbles and metal particles; (2) diagnosing handling-induced composition changes including changes caused by shear forces and by viscosity and temperature variation during processing. Both hardware and software innovations will be needed to accomplish these additional capabilities. The results of this work will be a powerful new manufacturing tool with unique capabilities to meeting critical needs for the biologics industry. ! !


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	SPHERYX, INC.	330 E 38TH ST	NEW YORK	NY	10016	NEW YORK	USA	National Center for Advancing Translational Sciences	000	5	10/23/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $996,838 )
2021	2021	SPHERYX, INC.	330 E 38TH ST APT 48J	NEW YORK	NY	10016	NEW YORK	USA	National Center for Advancing Translational Sciences	000	5	2/15/2021	NON-COMPETING CONTINUATION	$996,838
2021	2018	SPHERYX, INC.	330 E 38TH ST APT 48J	NEW YORK	NY	10016	NEW YORK	USA	National Center for Advancing Translational Sciences	001	3	8/22/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $996,838

Issue Date FY: 2020 ( Subtotal = $1,003,165 )
2020	2020	SPHERYX, INC.	330 E 38TH ST APT 48J	NEW YORK	NY	10016	NEW YORK	USA	National Center for Advancing Translational Sciences	000	4	3/10/2020	COMPETING CONTINUATION	$1,003,165
														Subtotal = $1,003,165

Issue Date FY: 2019 ( Subtotal = $113,502 )
2019	2019	SPHERYX, INC.	330 E 38TH ST APT 48J	NEW YORK	NY	10016	NEW YORK	USA	National Center for Advancing Translational Sciences	000	3	10/30/2018	SUPPLEMENT FOR EXPANSION	$113,502
														Subtotal = $113,502

Issue Date FY: 2018 ( Subtotal = $730,294 )
2018	2018	SPHERYX, INC.	330 E 38TH ST APT 48J	NEW YORK	NY	10016	NEW YORK	USA	National Center for Advancing Translational Sciences	000	3	6/20/2018	NON-COMPETING CONTINUATION	$730,294
														Subtotal = $730,294

Issue Date FY: 2017 ( Subtotal = $769,706 )
2017	2017	SPHERYX, INC.	330 E 38TH ST APT 48J	NEW YORK	NY	10016	NEW YORK	USA	National Center for Advancing Translational Sciences	000	2	7/6/2017	COMPETING CONTINUATION	$769,706
														Subtotal = $769,706

Grand Total All Awards = $3,613,505

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Instrument for Holographic Characterization of Protein Aggregates

Award Number: R44TR001590

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2016

PERIOD OF PERFORMANCE END DATE: 12/31/2022

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