A Canadian biotechnology company says it is ready to start commercial production of psilocybin mushrooms. Core One Labs Inc.which is based in Vancouver, is “on track to begin commercial production of its clinical-grade psilocybin in a Good Manufacturing Practices (GMP) facility in January 2023,” according to Benzinga.
The outlet reported that the company’s CEO, Joel Shacker, “explained that the company is on track with the initial phase of testing its commercial capabilities for high-grade psilocybin.”
“We anticipate positive results regarding Core One’s commercial capabilities and rapid progress in bringing our products to market; a step we anticipate will attract potential investors and appeal to our current shareholders,” Shaker said.
In October, Core One announcement that it was “nearly compliant with Good Manufacturing Practices (GMP) for the production of its psychedelic compounds, as the company has made progress in its negotiations with a certified facility and is developing a detailed plan to deliver high quality and affordable psychedelic drugs to duly authorized clinics and distributors”.
The company said at the time that its goal was to “create pharmaceutical-grade psychedelics for patients to treat a range of illnesses, including anxiety, depression, addictions, Parkinson’s disease and other mental health and neurological disorders”.
“By partnering with a GMP production facility, our plan is to start by manufacturing psychedelic compounds and putting them in an easy-to-take format for patients, like capsules. This can be done for Core One’s proprietary API-grade psilocybin as well as other compounds the company has tested. 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 its October announcement. “GMPs are a pillar of the quality assurance process which aims to ensure that products are manufactured in a consistent manner that meets or exceeds mandatory safety and quality standards.”
Benzinga Reports that, alongside the start of psilocybin production next month, Core One “intends to advance the market production of its other active pharmaceutical ingredient (API) psychedelic compounds to eventually manufacture and supply them to medical clinics and licensed professionals, researchers and treatment development companies across Canada and other countries as well.
The company “has developed and filed a patent for a new psilocybin production system using modified bacteria through its subsidiary Vocan Biotechnologies”, in addition to already holding “four provisional patents for the development of pharmaceutical formulations based on psychedelics targeting neurological and mental disorders under its Akome Biotech subsidiary as well as three provisional patents for additional synthetic technologies for psilocybin and psilocin production methods under the Awakened Biosciences subsidiary.
The company’s actions come at a time when Canadian leaders are reviewing laws and regulations surrounding psilocybin. In October, the province of Alberta began regulating the use of psychedelic drugs for people in therapy, a first for a Canadian jurisdiction and a move Core One hailed as “groundbreaking.”
“The new Alberta regulations would require medical directors to apply for a license before treating patients with psychedelics for mental health conditions. A psychiatrist would have to oversee any treatment, according to regulations in force in January 2023. Medical professionals could not bill for the drugs, and a trained professional must only give the drug to patients in a medical facility – unless the person is in palliative care. care”, the company said in October. “This important step taken by a Canadian government agency is groundbreaking, and the Society anticipates it to be the beginning of a complete paradigm shift in Canada.”