A Canadian biotech company says that it is ready to initiate commercial production of psilocybin mushrooms. Core One Labs Inc., which is based in Vancouver, is “set to begin commercial production of its clinical-grade psilocybin at a Good Manufacturing Practices (GMP) facility in January 2023,” according to Benzinga.
The outlet reported that the company’s chief executive officer, Joel Shacker, “explained that the company is on course with the initial phase of testing its commercial capabilities for high-grade psilocybin.”
“We anticipate positive results regarding Core One’s commercial capabilities and quickly moving towards commercialization of our products; a milestone we anticipated will attract potential investors and please our current shareholders,” Shacker said.
In October, Core One announced that it was “nearing good manufacturing practices (GMP) production of its psychedelic compounds, as the Company has progressed its negotiations with a certified facility and is developing a detailed plan to provide high quality and affordable psychedelic medicine to properly licensed clinics and distributors.”
The company said at the time that its goal was to “create pharmaceutical grade psychedelic products for patients to treat a range of diseases including, anxiety, depression, addictions, Parkinson’s and other mental health and neurological disorders.”
“By partnering with a GMP production facility, our plan is to start with manufacturing psychedelic compounds and putting them in an easy to take format for patients, such as capsules. This can be done for Core One’s proprietary API grade psilocybin as well as other compounds the Company has been testing. As Core One’s drug pipeline progresses, we plan to create our own drug formulations that can also be manufactured at these GMP facilities,” the company said in the announcement in October. “GMP is a pillar of the quality assurance process that seeks to ensure that products are manufactured in a consistent manner that meets or exceeds mandated safety and quality standards.”
Benzinga reports that, along with beginning psilocybin production next month, Core One “intends to advance market production of its other Active Pharmaceutical Ingredient (API) psychedelic compounds towards eventually manufacturing and supplying them to licensed medical clinics and professionals, researchers and treatment development companies across Canada and other countries as well.”
The company “has developed and filed a patent for a novel psilocybin production system using engineered bacteria through its subsidiary company Vocan Biotechnologies,” in addition to already holding “four provisional patents for the development of psychedelic-based pharmaceutical formulations that target neurological and mental health disorders under its subsidiary Akome Biotech as well as three provisional patents for additional synthetic technologies for psilocybin and psilocin production methods under subsidiary Awakened Biosciences.”
The moves by the company come at a time when Canadian leaders are revising laws and regulations surrounding psilocybin. In October, the Province of Alberta began regulation of the use of psychedelic drugs for people in therapy, a first for a Canadian jurisdiction and a decision that Core One hailed as “groundbreaking.”
“Alberta’s new regulations would require medical directors to apply for a license before treating patients with psychedelics for mental health disorders. A psychiatrist would have to oversee any treatment, according to the regulations taking effect in January 2023. Health professionals could not charge money for the drugs, and a qualified professional must only give patients the drug at a medical facility – unless the person is in palliative care,” the company said in October. “This significant step being taken by a Canadian government body is groundbreaking, and the Company foresees this as the beginning of a complete paradigm shift in Canada.”