Integrated Protein Technologies, Inc. has been developing the SampleStream platform, our flagship technology that enables rapid buffer exchange and protein concentration in both online and offline modes. As originally proposed, our efforts development efforts are aimed at developing prototype devices to place with strategic partners. As of ASMS 2019, we have now developed three-way collaborations with Bruker and AbbVie (one of our original beta test partners) as well as Bruker and Pfizer and continue our collaboration with Genentech. These collaborations will provide invaluable feedback, enable us to develop methods specifically for biopharma, and imprint an OEM model in which IPT sells our technology to major vendors who then add menu. As originally proposed, we also sought to work with a laboratory developed test (LDT) provider. We have recently developed a relationship with the clinical arm of Thermo Fisher Scientific to begin exploring the SampleStream platform?s use in LDT. To prepare for these applications, IPT must turn our attention towards the FDA?s Quality System Regulations (QSR) as well as the international standard, ISO 13845. Therefore, we seek a strategic supplement that will enable implementation of these regulations during our initial design and development cycle, providing huge expansion of our potential market with the premium pricing associated with diagnostics. To this end, we have partnered with an experienced quality consulting company, NJK & Associates. Also included in this supplement are additional funds to enable our membrane consumable to be further developed to eliminate potential mis-use and enable tracking of individual consumables and the lots from which these originated. These aspects are absolutely crucial to the future success of the platform in regulated environments. The speed, flexibility and simplicity of the SampleStream platform makes it ideally suited to LDT and in vitro assays and we are excited to move aggressively towards this endpoint with our partners, building value in a new technology and transforming the way diagnostics are performed.

Public Health Relevance

Integrated Protein Technologies, Inc. is developing a new platform technology for the direct analysis of intact proteins via mass spectrometry. In this strategic supplement, we seek additional funding to augment our development efforts by implementing the quality system regulations required by the Federal Drug Administration for type I and type II medical devices and further developing our membrane consumable to reduce error modes and enable sample chain of custody. Combined, these supplemental activities will enable IPT to engage our collaborators in the clinical space in an effective and efficient manner.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
3R44GM121130-02S1
Application #
9954191
Study Section
Program Officer
Krepkiy, Dmitriy
Project Start
2017-09-14
Project End
2021-01-31
Budget Start
2019-02-15
Budget End
2020-01-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Integrated Protein Technologies, Inc.
Department
Type
DUNS #
078462901
City
Evanston
State
IL
Country
United States
Zip Code
60201