Creating GMP-Grade CBD: Drug Developers Eyeing Synthetic Cannabinoids
The cannabis industry is already making big waves and big money in the U.S. in spite of being legally available in only a few markets. In 2016, the U.S. industry alone was estimated to be worth $7.06 billion and is forecasted to grow rapidly by 2025.
What does not grow as rapidly is the plants themselves. While many pharmaceutical companies are eyeing the potential benefits of developing cannabinoid-derived treatments, the capital investment in producing the plants themselves is proving a major obstacle, both in terms of finding sufficient farmland and in obtaining the required permits to grow a plant that is so heavily regulated.
However, the race to produce cannabidiol or CBD that meets GMP certification standards is producing some innovative thinking. Recently, breakthroughs in producing CBD by engineering yeast compounds have proved a promising and reliable way to ensure GMP certification, removing many of the issues that can arise in using a plant-based product, including mold, residual pesticides and other impurities. Synthetic CBD has the potential to be consistent in quality and purity, which is extremely important as safety regulations are still being designed and implemented across all markets.
Cannabidiol is of particular interest to pharmaceutical companies as it has many of the therapeutic properties of cannabis use, including pain relief, but does not produce the high typically associated with the drug.
One of the breakthroughs on the market with a GMP certification is Epidiolex, an epilepsy treatment and the first cannabis-derived drug to be cleared by the FDA. It was recently reclassified as a Schedule V drug, pointing to the safety of these cannabinoids.
What do these developments mean for pharmaceutical professionals? Those who work in good manufacturing practices know that the landscape is always changing, and part of being in the pharmaceutical industry is constantly working to understand the changes. However, cannabis is poised to be particularly disruptive, and being prepared is the order of the day.
Our GMP certification program Become a Current Good Manufacturing Practices (cGMP) Certified Professional™ is aimed at getting you ahead of the curve, wherever you are in the pipeline, from R&D through to product manufacture. Our courses comply with cGMP mandates, and provide comprehensive analysis and instruction from leading industry professionals who have extensive experience in the field. We encourage our students to ask questions and engage with new developments to ensure your training is as up-to-date as possible.
For more information visit the program page or contact us.
Sources:
https://www.grandviewresearch.com/press-release/global-legal-marijuana-market
https://investingnews.com/innspired/synthetic-cbd-cannabis-based-pharma-drugs/
https://news.berkeley.edu/2019/02/27/yeast-produce-low-cost-high-quality-cannabinoids/
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