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Novel Nanofiltration Membranes for Isolation of Pharmaceutical Compounds II

Award Number: R44GM103402
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2011
PERIOD OF PERFORMANCE END DATE: 12/31/2020

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Novel Nanofiltration Membranes for Isolation of Pharmaceutical Compounds II - DESCRIPTION (provided by applicant): In the manufacture of pharmaceutical compounds, organic syntheses are often carried out in organic solvents. These solvents must then be separated from high value intermediates and active pharmaceutical ingredients (APIs) in order to produce the final product medications. Many intermediate compounds and APIs are thermally labile and thermal separation processes such as distillation/thermal evaporation are not preferred. In addition, distillation and evaporation processes are energy intensive, making them costly to operate. Nanofiltration (NF) is a superior alternative to phase change based separation processes such as distillation and evaporation. In contrast to phase change separations, nanofiltration is a molecular level size-sieving based separation process and can be operated at ambient or sub-ambient temperatures. In NF, driven by the applied pressure gradient, low molecular weight compounds such as solvents permeate through the nanofiltration membrane while higher molecular weight compounds are retained. Although nanofiltration technology for aqueous systems is well established, the technology for organic solvent nanofiltration (OSN) systems is still under development. There are very few examples of pilot and industrial scale applications of OSN in the pharmaceutical industry. The primary limitation of OSN in API purification is low product yield due to loss of the product through the membrane. Stated another way, the high loss of product hinders the widespread application of membranes in the pharmaceutical industry and solvent resistant OSN membranes that are more selective and/or more selective solvent resistant OSN membrane processes are needed. The broad objective for the phase II program is to develop nanofiltration membrane processes that provide clear economic advantages over distillation and evaporation processes for separating solvents from APIs with the molecular weights in the range of 300 to 2000 g/mol. Compact Membrane Systems will develop OSN membrane technology with superior membrane performance (solvent flux and solute rejection) and superior membrane stability in pharmaceutical solvent systems compared to currently commercial OSN membranes. These membranes will be the key component of OSN systems that can be used as stand-alone unit operations or combined with other unit operations for the separation of solvents from intermediates and APIs in commercial pharmaceutical manufacturing processes. In addition to solvent/API separation, these OSN membranes may be useful in solvent exchange, genotoxic impurity separation, crystallization, and chemical synthesis operations.


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: 2021 ( Subtotal = $0 )
2021	2017	COMPACT MEMBRANE SYSTEMS, INC.	335 WATER ST	WILMINGTON	DE	19804	NEW CASTLE	USA	Biomedical Research and Research Training	000	4	6/4/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2017	COMPACT MEMBRANE SYSTEMS, INC.	335 WATER ST	WILMINGTON	DE	19804	NEW CASTLE	USA	Biomedical Research and Research Training	000	4	2/12/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	COMPACT MEMBRANE SYSTEMS, INC.	335 WATER ST	WILMINGTON	DE	19804	NEW CASTLE	USA	Biomedical Research and Research Training	000	4	7/17/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $828,871 )
2017	2017	COMPACT MEMBRANE SYSTEMS, INC.	335 WATER ST	WILMINGTON	DE	19804	NEW CASTLE	USA	Biomedical Research and Research Training	001	4	8/18/2017	NON-COMPETING CONTINUATION	$791,581
2017	2016	COMPACT MEMBRANE SYSTEMS, INC.	335 WATER ST	WILMINGTON	DE	19804	NEW CASTLE	USA	Biomedical Research and Research Training	000	3	8/14/2017	COMPETING CONTINUATION	$37,290
														Subtotal = $828,871

Issue Date FY: 2016 ( Subtotal = $859,472 )
2016	2016	COMPACT MEMBRANE SYSTEMS, INC	335 Water St	Wilmington	DE	19804	NEW CASTLE	USA	Biomedical Research and Research Training	000	3	9/12/2016	COMPETING CONTINUATION	$859,472
														Subtotal = $859,472

Grand Total All Awards = $1,688,343

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Novel Nanofiltration Membranes for Isolation of Pharmaceutical Compounds II

Award Number: R44GM103402

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2011

PERIOD OF PERFORMANCE END DATE: 12/31/2020

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