Eurofins BPT Toronto expands psychedelics testing and certification services to support mental health therapies
by Douglas J. Turk, Ph.D., Business Unit Manager Eurofins BioPharma Product Testing Toronto, douglasturk@eurofins.com
Research on the use of psychedelics and natural or synthetic hallucinogenic drugs has seen considerable increase in recent years for medical therapies to manage significant psychological and behavioural changes in anxiety, mood disorders, addiction, substance abuse, PTSD and depression, which are on the rise.
The mind-altering effects of psychedelics as a therapy are currently being used in controlled environments to manage a number of psychiatric disorders, including the use of psilocybin-assisted treatment for alcohol addiction, MDMA (ecstasy) use for the treatment of post-traumatic stress disorder (PTSD), and LSD assisted therapy to improve mood and anxiety disorders, among several others.
The Food and Drug Administration (FDA) designated psilocybin-assisted therapy as a breakthrough therapy in 2019. And with the ever increasing number of clinical trials evaluating numerous other novel psychedelic treatment drug candidates, there is an increasing need for the development of suitable analytical methods, testing, and characterisation of the proposed psychedelic drug products.
Breakthrough therapy designations are intended to expedite the development and review of new drugs for serious or life threatening conditions. Regulatory agencies will often expedite approval for these “fasttrack” or “breakthrough” designated therapies, but this requires a leading edge CRO who can meet these accelerated testing needs.
Eurofins BioPharma Product Testing in Toronto is authorised by Health Canada to provide GMP analytical services for testing controlled psychedelics such as psilocybin, psilocin, DMT, LSD, mescaline, 2C-B, and MDMA from medicinal mushrooms and hallucinogenic or synthetic psychedelic drugs.
Hallucinogenic active ingredients are controlled by Health Canada under Schedule III of the Controlled Drugs and Substances Act (CDSA). In order to legally possess and provide analytical services related to controlled substances, contract laboratories must be authorised by Health Canada with an applicable Dealer’s License.
A Dealer’s License from Health Canada is not limited to the possession, selling, production and transportation (i.e. importation/exportation) of controlled substances, but also includes testing. Eurofins BPT laboratory in Toronto is cGMP compliant and offers a range of analytical and regulatory solutions for psychedelics, including:
- Method development, transfer and validation
- Chemistry & microbiology release testing
- Onsite environmental monitoring
- Regulatory services: applications/submissions
- QA services: CAPA, SOPs, and GMP training
- Assistance with with compliance & regulations
For more information visit: www.eurofins.ca
