New Data Describe Lab-Grown Amebocytes (aLAL™) That Aim to Match Native LAL Performance While Solving Supply, Cost and Sustainability Constraints

GERMANTOWN, MARYLAND / ACCESS Newswire / September 4, 2025 / MygoGenesis, a biotechnology company pioneering cell-origin materials through its Mygotic Process™, today announced the release of a new white paper, "Advances in Using Sustainably Generated Amebocytes to Ensure Affordable and Effective Endotoxin Testing." The paper presents scientific and operational evidence supporting aLAL™ - a lysate produced from lab-grown amebocytes - as a sustainable path to high-quality bacterial endotoxin testing.

Harvesting the Blood of Horseshoe Crabs
More Than 1M Horseshoe Crabs are Harvested in the U.S. Each Year for Biomedical Testing

For over 50 years, Limulus Amebocyte Lysate (LAL) from horseshoe crabs has been the global standard for safeguarding injectables, biologics, and medical devices. However, dependence on crab harvesting has introduced ecological strain, supply volatility, and batch variability - pressures that drive up costs and risk. Recombinant approaches have helped, but practical limitations (including low endotoxin recovery and matrix effects) remain.

"MygoGenesis' mission is to unlock ethical, scalable biology that accelerates innovation without compromising the planet," said Deborah Zimmermann, President and CEO of MygoGenesis. "aLAL™ represents a breakthrough: lab-grown amebocytes designed to retain the broad, native cascade of LAL while delivering the consistency, supply assurance, and affordability industry needs. We believe this platform can catalyze better safety testing across pharma, medical devices, water quality, and beyond."

Key points from the white paper include:

• A proprietary approach to producing lab-grown amebocytes and formulating aLAL™ to support gel-clot, turbidimetric, and chromogenic assays.

• Comparative results indicating comparable detection across a range of EU concentrations versus traditional LAL, alongside immunochemical evidence of cascade parity (e.g., Factor C light-chain).

• A roadmap for validation under established pharmacopoeial and quality-system expectations to facilitate adoption.

• The potential to de-risk global supply chains, reduce batch-to-batch variability, and lower total testing costs.

"This is a step-change," said Daniel Kilbank, founder and Chief Scientific Officer of MygoGenesis. "For the first time, we can produce functionally relevant amebocytes at scale - not a single recombinant component, but the multi-factor lysate biology industry relies on. That opens the door to consistent performance without harvesting wild horseshoe crabs, expanding access to high-quality endotoxin testing and enabling entirely new applications."

The white paper is available for download here: [Link coming soon].

About MygoGenesis

MygoGenesis is an innovative biotechnology company developing cell-origin materials via its proprietary Mygotic Process™ to solve supply, sustainability, and performance bottlenecks in life sciences. From aLAL™ (lab-grown amebocytes for endotoxin testing) to future applications in diagnostics, water quality, and consumer product safety, MygoGenesis partners with industry leaders to translate breakthroughs into real-world impact. Learn more at mygogenesis.com.

About AmeboGenesis

AmeboGenesis, a division of MygoGenesis, focuses on sustainable amebocyte biology for quality-critical testing. By replacing wild-harvest horseshoe crabs with lab-grown amebocytes, AmeboGenesis seeks to stabilize supply, reduce ecological impact, and improve reproducibility for global endotoxin testing workflows. Visit amebogenesis.com.