The startup operates a diagnostic testing company focused on endotoxin testing for pharmaceutical and biopharmaceutical products, utilizing a magneto-optical detection platform combined with enzymes for enhanced sensitivity. This technology minimizes sample and reagent usage, enabling biotechnology and medical companies to ensure product safety and regulatory compliance efficiently.
Funding
$3.8M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Current endotoxin testing methods for pharmaceutical and biopharmaceutical products can be time-consuming, require large sample volumes, and may not offer the sensitivity needed for certain applications. Traditional methods also often rely on substantial amounts of FDA-licensed Limulus Amebocyte Lysate (LAL) reagent, increasing costs and potentially impacting sustainability.
Solution
Cotton Mouton Diagnostics (CMD) provides an endotoxin testing system, αBET®, that combines a magneto-optical detection platform with enzymatic reactions to enhance sensitivity while minimizing sample and reagent usage. The αBET® system delivers quantitative results in approximately half the time of traditional turbidimetric LAL assays, using less than 10% of the standard LAL reagent volume. The system walks users through pharmacopoeial compliant assays, while also allowing for flexible sample analysis. CMD also offers ISO 9001 and ISO/IEC 17025 accredited endotoxin testing services for liquid pharmaceutical products, method development, validation, and low endotoxin recovery studies.
Target Audience
The primary customers are biotechnology and pharmaceutical companies, quality control laboratories, and research and development facilities that require efficient, sensitive, and compliant endotoxin testing solutions.
Features
- Magneto-optical detection technology for enhanced sensitivity and rapid results
- Reduced LAL reagent consumption for cost-effectiveness and sustainability
- On-board software compliant with FDA 21 CFR Part 11 for data integrity
- Capability to perform pharmacopoeial compliant assays
- System adaptable for both in-process and final product endotoxin testing
- Contract testing services for routine sample analysis, method validation, and low endotoxin recovery studies
- Compatibility with recombinant cascade reagents