BioMagnetic Solutions LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant The notion of adoptive cellular immunity was first conceived and reported by A V Mitchison more than years ago Since then extraordinary human effort and ingenuity has resulted in fundamental understandings of molecular biology the immune system genetics gene therapy and the dreaded disease cancer That has enabled the creation of incredible tools inconceivable a generation ago which has put medical science on the threshold of cancer cures One part of that andapos tool boxandapos is the isolation of subsets o immune cells from patients donors and the purification of genetically modified cells Currently CD cells are the prime targets of such separations Cost effective efficient separations are vitally important given the expense such treatments entail The goal of this proposal is to test the feasibility of a clinical scale immuno magnetic cell separation system that has the potential to be faster fold cheaper fold and better yield andamp purity for the isolation of CD cell than the system of Miltenyi Biotec and other improvised systems in use at many centers This proposal is based on extraordinary benefits our magnetic nanoparticles confer to cell separations These ferrofluids are crystalline quasi spherical nm cores of magnetite crystals coated with modified protein to which common capture agents streptavidin antibodies or Mabs direct conjugates are coupled They are stable have been in commercial use more than years and are the key component of the FDA approved CellSearch r circulating tumor cell enrichment scheme Benefits a rapid binding kinetics as they diffuse b extraordinary surface area thus low mass input for targeting c most magnetic superparamagnetic materials in existence greater than magnetite most magnetic superparamagnetic material d easy to GMP manufacture and filter sterilize e separable from open vessels test tubes flow through chambers closed containers vs Miltenyiandapos s that require ultra high gradient magnetic forces ball bearing packed expensive and inefficient columns With in house designed magnetic devices ferrofluids can collect cells in monolayers or multilayers that are easily retrievable Unlike larg Dynal Dynabeads ferrofluids do not damage cells clutter up cell surfaces nor affect cell viability This work benefits from years of extensive Randamp D in improving our ferrofluidsandapos magnetics and surface chemistries resulting in use of less material significantly lower non specific binding and improved purity as well as more latitude in collection chamber design because of their magnetics From fundamental discoveries on cell separation that use very little Mab it is feasible to target of a cell starting product with ug of Mab vs ug for competing systems and with only mg of th generation ferrofluid And the entire separation can be done in less than minutes Our skill set experience PI founded managed Immunicon Corp conceived of CellSearch r designed seminal experiments showing that tumor cells circulate early on in cancers recruited the development team for commercial and FDA approved system and started the corporate partnership with Johnson andamp Johnson All of that began with a Phase I SBIR A V Mitchison J Exp Med Aug The PI was fortunate to have had the benefit of close contact and interactions with Av Mitchison University College London while the PI was a Visiting Scientist at NIMR Mill Hill working in the laboratory of the late Bridgette Askonas We had many discussions on how to use the immune system to attack malignancies PUBLIC HEALTH RELEVANCE CD cell separations for the rapidly developing and paradigm changing field of CAR T TCR cell therapy can only be performed by one commercial system or those improvised at centers both of which are costly in reagents and technical manpower As the successor to Immunicon Corp developer of the FDA approved CellSearch r immuno magnetic system for rare cell isolation BioMagnetic Solutions BMS brings over years of immuno magnetic know how to the table With radically new cell separation technology we will develop a highly improved clinical scale immuno magnetic cell separation system that is faster fold cheaper fold and better yield and purity for CD T cell isolations that wil require less expensive MAb Using BMSandapos market tested th generation ferrofluids immuno magnetic IP for rapid inexpensive cell separations BMS will partner with a major cell processing group or CAR T consortium to rapidly introduce its clinical scale immuno magnetic separation technology and novel magnetic platform into the clinic and marketplace