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DEVELOPMENT OF A NOVEL PRODUCTION PLATFORM FOR COMPLEX RECOMBINANT BIOTHERAPEUTIC

Award Number: R43HL110448
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2012
PERIOD OF PERFORMANCE END DATE: 02/28/2013

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DEVELOPMENT OF A NOVEL PRODUCTION PLATFORM FOR COMPLEX RECOMBINANT BIOTHERAPEUTIC - DESCRIPTION (provided by applicant): The manufacturing of recombinant protein-based biopharmaceuticals is a complex, labor and capital intensive endeavor. It currently is accepted that the use of mammalian cells is a requirement for the production of most human proteins, which typically contain extensive post-translational modifications that are not performed by prokaryotes and single-celled eukaryotes. Although mammalian cells such as Chinese hamster ovary cells and baby hamster kidney cells can faithfully biosynthesize most human proteins, the efficiency is dramatically lower than is achieved by bacterial or yeast cells. Of the recombinant proteins currently marketed, coagulation factor VIII is manufactured with the lowest efficiency and is by far the most expensive on a per unit mass basis. Other expensive and difficult to manufacture biopharmaceuticals include the other coagulation factors (e.g. factors IX and VIIa), interferon, and hormone-based cytokines. The goal of the current application is to develop a technology that can improve the production volume and pharmacy price of these difficult to manufacture recombinant biologics. Expression Therapeutics has developed a new baby hamster kidney-derived (BHK) cell line, designated BHK-MS, which can be cultured and expanded indefinitely in serum and blood product-free medium under suspension bioreactor conditions. In the current studies, we are 1) developing and validating the suspension adapted BHK-MS cell line for superior coagulation factor VIII and factor IX production, and 2) performing a pilot-scale manufacturing run and analyzing the biochemical and pharmaceutical characteristics of BHK-MS biosynthesized recombinant factor VIII and factor IX, which will serve as a model, difficult to manufacture biopharmaceuticals. PUBLIC HEALTH RELEVANCE: The long-term commercial objective of the current project is to commercialize a suspension cell-based biomanufacturing platform designed for improved volumetric productivity of complex, hard to manufacture biologics. Low-yield manufacturing processes currently in place often result in limited product availability and high-product costs. Expression Therapeutics has developed a patent-pending cell line designed for efficient manufacturing of recombinant biologics. The studies proposed herein are designed to provide proof-of-concept of the efficiency and scalability, as well as, rigorous preclinical validation and characterization of this novel manufacturing platform.


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: 2012 ( Subtotal = $296,320 )
2012	2012	EXPRESSION THERAPEUTICS	2205 Corp Plz Pkwy SE	Smyrna	GA	30080	COBB	USA	Blood Diseases and Resources Research	000	1	8/1/2012	NEW	$296,320
2012	2012	EXPRESSION THERAPEUTICS	1441 LOGAN CIRCLE	MARIETTA	GA	30062	COBB	USA	Blood Diseases and Resources Research	001	1	8/3/2012	NEW	$0
														Subtotal = $296,320

Grand Total All Awards = $296,320

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DEVELOPMENT OF A NOVEL PRODUCTION PLATFORM FOR COMPLEX RECOMBINANT BIOTHERAPEUTIC

Award Number: R43HL110448

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2012

PERIOD OF PERFORMANCE END DATE: 02/28/2013

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