Making the SampleStream Platform a Medical Device

Integrated Protein Technologies, Inc., Evanston IL

Investigators

Linked publications & trials

Abstract

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.