SBIR Phase I: A Novel Horseshoe Crab Device and Approach for a Sustainable Endotoxin Testing Resource

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is the development of a cost-effective, environmental and economically sound Limulus amebocyte lysate (LAL) production facility based on a finite number of horseshoe crabs (HSC) using minimally impactful and novel bleeding procedures. The goal is to address the demands of an estimated $114 million LAL market and finished kit market in excess of $1 billion per annum. Success of this project also anticipates exceeding current standards by ensuring biomedical and pharmaceutical manufacturing compliance with fewer total horseshoe crabs than the number that die annually from current practices. New approaches to HSC bleeding developed in this project would also enable repeated, controlled bleeding while maintaining optimal conditions for animal vitality and for the adjacent communities. Assuming optimized, scalable HSC bleeding operations could eventually expand current supplies, innovative applications could be developed. For example, early detection of sepsis could help avert some $30 billion in direct care every year in the US, notwithstanding the potential to save countless lives with development of gram-negative screening tools for hospital acquired septicemia. This SBIR Phase I project proposes to develop an alternative method of bleeding horseshoe crabs (HSCs) for Limulus amebocyte lysate (LAL) harvest. The overarching objective to demonstrate the proof-of-concept of an implantable, and surgical-grade device engineered to facilitate routine bleeding, without compromising the integrity and well-being of the HSC. This will be achieved via a systematic study of HSC bleeding outcomes to investigate whether such a device can meet the sterility and quality standards of traditional approaches, while obviating the need for extraneous transport to expensive, inland bleeding facilities. Furthermore, the commercial opportunity and feasibility of the device paired with a habitat-based, enclosed system to systematically monitor HSC wellbeing will be investigated. This SBIR Phase I project would be the first to investigate an alternative approach to bleeding HSCs, a technique that has not changed significantly since the late 1800's. At scale, the proposed approach would also be expected to improve product quality and traceability, and ultimately the bottom line of companies producing LAL kits, given a surplus of LAL in the supply chain. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.