Research and regulatory collaboration between Canadian biotechs Red Light Holland TRUFF and PharmAla MDXXF is bearing fruit. The partners are moving forward with a new project to bring Active Pharmaceutical Ingredient (API) extraction from Red Light’s psilocybin truffles to a commercial manufacturing scale.
An Ontario-based company producing, growing and selling functional mushrooms and mushroom home-grow kits in North America and Europe and premium psilocybin truffles in the Netherlands, Red Light Holland (RLH) recently hired MDXX-class molecules developer PharmAla for a one-year collaboration to seek regulatory approval for selling standardized doses of natural psilocybin products to clinical trials, government-approved access programs and emerging markets.
The experimental research on psilocybin truffles and API extraction will be managed by PharmAla researchers. The study is expected to yield "a process for the extraction and subsequent purification of psilocybin into a form such that it can be formulated into medical products for use in a variety of markets."
The psilocybin truffles recently imported to Canada through RLH's partner CCrest Labs will serve as starting material for the process development, which aims to be specific and standardized to enable its transfer to several facilities, for "full-scale" GMP manufacturing.
“While we have seen excellent movement in a number of emerging markets, it has become clear that there is also a demand for a range of medical products based off of psilocybin mushrooms and truffles and optionality is key in our two-pronged approach,” explained Red Light Holland CEO and director Todd Shapiro.
With this in mind, developing a process to manufacture natural-source psilocybin API would enable RLH "to produce high-margin psilocybin medical products – and gain valuable intellectual property,” Shapiro added.
Photo: Benzinga edit with photo by geralt and sergeitokmakov on Pixabay.
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