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A bio-identical and non-animal replacement for the quality control reagent of pyrogen testing in the medical and pharmaceutical industries.

Periodic Reporting for period 1 - LimuleX (A bio-identical and non-animal replacement for the quality control reagent of pyrogen testing in the medical and pharmaceutical industries.)

Reporting period: 2018-05-01 to 2018-09-30

A pyrogen is a fever inducing substance when introduced or released into the bloodstream, typically introduced by bacterial contamination. Bacterial endotoxins are lipopolysaccharides present in the cell walls of Gram-negative bacteria.
Pyrogen testing is a fundamental necessity in quality control for product safety in the regulated biomedical industries. For example, parenteral preparations have to be pyrogen-free because administration of pyrogens may induce fever, shock or even death. The severity of the adverse reaction depends on the concentration and biological activity of the respective pyrogen. The gold standard and de facto industry norm for pyrogen tests is a reagent called LAL (Limulus Amoebocyte Lysate).

Challenges:
For the past 60 years, the sole source for making LAL has been the blue blood of the Atlantic Horseshoe Crab. Even at current harvest rates, the product is unsustainable. Demand is forecast to more than double in the next 5 years. Moreover, there are longstanding challenges in the upstream side of the LAL supply chain.

Our Solution:
Our bio-identical LAL (LimuleX) is produced using animal free technology. This removes the declining animal source from the equation, modernizing the outdated supply chain and making a better quality product.

Our objectives include:
• Establishing reliable, animal free reagent production
• Developing a robust distribution model
• Securing pharmaceutical, medical device and new market opportunities
Task 1. Refining desirable end product characteristics through engagement with end users.
Actions:
• Contacted and involved clients/ end-users to gather feedback on user needs and requirements.

Task 2. Develop a feasible production and commercialisation plan.
Actions:
• Established a detailed product development plan, supported by the agile development methodology, to list the technical activities necessary to make the product ready for commercialisation.
• Scouted and identified key suppliers/stakeholders/contract manufacturers to meet large scale market demand.
• Defined infrastructure requirements for in-house manufacturing.

Task 3. Plan the pilot trials for market test
Actions:
• Scouted and selected potential customers/end-users to get involved. Identified locations, duration and criteria for success of the operational tests.

Task 4. Conducting extensive commercial viability checks and establishment of go-to-market strategy
Actions:
• Gauged reliable market share through assessing the serviceable available market (SAM) out of the total (TAM) through a realistic bottom-up approach.
• Analysed target customer segments and their willingness to pay.
• Estimated the number of reachable customers according to existing contacts and market studies.
• Reviewed/updated competition analysis.
• Scouted strategic partnerships, facilitating sales and clients outreach.
• Identifed and contacted sales channel/distributors and potential clients in the initial target countries (EU DACH).
• Defined specific communication actions and marketing for the target audiences.

Task 5. Business model verification
Actions:
• Reviewed pricing strategy by talking to relevant stakeholders and considering their economic benefit.
• Established the organizational plan and full operations management (incl. personnel’s growth) to scale up business. Estimate 5-years financial projections, cash flow, profit and loss, break even and ROI.

Task 6. Branding and licensing strategy
Actions:
• Expanded the IP management strategy beyond core patent filings.
• Revised peripheral IP protection strategy.

Task 7. Analysis of risks and opportunities related to successful market introduction.
Actions:
• Elaborated on internal risk assessment and contingency planning. Both technical and regulatory.
o Sothic has established collaborations and partnerships through the course of 2018, these are both strategic (product distribution and sales) as well as research (product validation, refinement and manufacturing).

o As the security of Horseshoe Crab derived LAL reagent supply remains in question, the LimuleX initiative is now closely aligned with the principles of Replacement, Reduction and Refinement (3Rs) in the use of animals for test purposes.

o This study has shown the importance of replacement of in vivo methods for animal welfare and for ensuring consistency of testing in human health/ diagnostics as well as the pharmaceutical supply chain.
Product and branding strategies for LimuleX