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Engineering a new insect cell line for human-type protein glycosylation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43GM125397-01A1
Agency Tracking Number: R43GM125397
Amount: $217,385.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA17-302
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-04-01
Award End Date (Contract End Date): 2020-03-31
Small Business Information
1938 HARNEY STREET
Laramie, WY 82072-3037
United States
DUNS: 968784103
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 CHRISTOPH GEISLER
 (307) 340-1616
 christophgeisler@gmail.com
Business Contact
 DONALD JARVIS
Phone: (307) 766-4282
Email: dljarvis@uwyo.edu
Research Institution
N/A
Abstract

Abstract
The global market for `biologicsandaposwhich are new generation drugs produced using genetically engineered
biological systemsis projected to reach $billion byOne system currently being used to
manufacture biologics is the baculovirus insect cell systemBICSThe BICS offers certain advantages over
more widely used mammalian cell systemsincluding its rapid adaptability for manufacturing different productsuse of a single qualified master cell bank for all productsabsence of endogenous retrovirusesand superior
ability to produce multiprotein complexesIt also presents an alternative for products that are poorly produced
in mammalian cell systems and enhances manufacturing capacityHoweverthe BICS cannot be used to
manufacture glycoprotein biologicsthe most common typebecause it cannot produce the human type
carbohydrate side chainsor `N glycansandaposrequired for their clinical efficacyGlycoBac has shown we can solve
this problem using our patented technology to produce insect cell derivatives that can synthesize human type
N glycansSo farour `glycoengineeringandaposefforts have focused on cell lines derived from SfrugiperdaSfbecause they are most commonly used in the BICSHoweverTniTncell lines are also used and have the
capacity for higher productivityConsidering thisglycoengineered Tn cell lines would be highly attractive to
glycoprotein biologics manufacturersUnfortunatelyglycoengineering currently available Tn lines would be
useless because these lines are contaminated with a virusand produce immunogenic N glycansThese problems have thwarted GlycoBacandapos s opportunity to leverage our technology and glycoengineer Tn cellswhich would double our product catalogThuswe isolated a newpatent pending Tn line that has no viral
contaminants and produces no immunogenic glycansWe now propose to use this line to demonstrate the
feasibility of Tn glycoengineeringFirstwe will knockout the endogenous fused lobesfdlgenewhich
antagonizes human type N glycan elongationWe will do this using our newpatent pendinglepidopteran
insect specific CRISPR Castoolswhich will provide a competitive advantageSecondwe will knock in
heterologous genes required for human type N glycan synthesis using our established technologywhich also
will provide a competitive advantageand characterize the productThe results will reveal if it is feasible to
glycoengineer Tn cells and isolate derivatives that can produce glycoproteins with human type N glycansA successful outcome will set the stage for Phase IIin which we would produce a full suite of glycoengineered
Tn derivatives designed to produce recombinant glycoproteins with various clinically relevant N glycan
structuresWe would extensively characterize these lines and document their safety and efficacyThese new
glycoengineered insect cell lines would grow GlycoBacandapos s businesseffectively doubling our catalogas noted
aboveThis would enhance global manufacturing capacity for glycoprotein biologicswhich have the biggest
impact on human health andthereforeenhance the biotechnology sectorsandaposefforts to improve human health Narrative
The global market for `biologicsandaposwhich are new generation drugs produced using genetically engineered
biological systemsis projected to reach $billion byThe baculovirus insect cell system is
currently being used to manufacture biologicsbut this system has a key technical limitation that restricts its
utility to a small segment of the overall biologics manufacturing marketThis Phase I SBIR project will
assess the feasibility of using GlycoBacandapos s patented technology to overcome this restriction by creating a
new suite of insect cell lines fornd generation baculovirus insect cell systems that can be used to
manufacture a broader selection of biologics and increase our share of this large market

* Information listed above is at the time of submission. *

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