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A high-efficiency, low-cost, single-use purification technology for therapeutic antibody manufacturing

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM134776-01
Agency Tracking Number: R41GM134776
Amount: $248,762.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-01
Award End Date (Contract End Date): 2020-08-31
Small Business Information
BONDWELL TECHNOLOGIES, INC.
College Station, TX 77845-6545
United States
DUNS: 080815101
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 SARAH BONDOS
 (979) 845-5399
 sebondos@medicine.tamhsc.edu
Business Contact
 DAVID HOWELL
Phone: (979) 475-4545
Email: dhowell@bondwelltech.com
Research Institution
 TEXAS A&M UNIVERSITY HEALTH SCIENCE CTR
 
400 HARVEY MITCHELL PARKWAY SOUTH, SUITE 300
COLLEGE STATION, TX 77845-4375
United States

 Nonprofit college or university
Abstract

Therapeutic antibodies have had a profound impact on treatment of many types of cancer and autoimmune diseasesAs a resultfive of the top ten best selling drugs ofwere therapeutic antibodiesMore than seventy therapeutic antibodies have been approvedand over six hundred antibody based products are in clinical developmentHoweverantibodies are extremely expensive to produceand large amounts of antibody are required to achieve clinical efficacyDuring our market research through the prestigious I Corps programall of the industry experts interviewed cited Protein A chromatography as the largest pain point in antibody manufacturingThe Z Domain of Protein A specifically binds the constant region of human antibodiesand thus can be immobilized on a resin or membrane and used to purify a wide variety of therapeutic antibodiesThe two largest concerns wereithe cost of Protein A modified chromatography resins or membranes andiithe time lost to lengthy cleaning proceduresThe goal of the proposed studies is to use new material and immobilization technology to produce a low costsingle use Z Domain immobilized membrane with high binding capacity and flow rateOur singlepot materials synthesis approach eliminates a work intensivefailure prone step from materials productionreducing the cost of membrane production and making single use application feasibleIn additionthis technology can increase binding capacity by nearlyfoldenabling its application for large scale purificationsFurthermorethese materials significantly stabilize incorporated proteinsfacilitating use and improving storageThe proposed studies of this proposal are designed to validate this approach in three value added milestonesMeasure static and dynamic binding capacityAimexamine antibody purityAimand assess the durability of the materialsAimall necessary steps in product development Therapeutic antibodies have had a profound impact on the treatment of many diseasesbut are extremely expensive to produceNovel materials developed by Bondwell TechnologiesInchave the potential to dramatically increase binding capacity in a low costsingle use productThe proposed studies will validate this technology as an antibody purification platform

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

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