Lonza will be supporting Emerald Health Pharmaceuticals through clinical trials of its synthetic derivative of cannabidiol (CBD), by manufacturing the liquid encapsulation solution to provide trial participants with current good manufacturing practice (cGMP) quality therapies in an accessible format.
Per the agreement, Lonza will synthesize the active pharmaceutical ingredient (API) and drug substance (VCE -004.8) to develop the drug product, EHP-101 as liquid-filled capsules.
Christian Dowdeswell, head of dosage form and delivery systems, Lonza, told us that from an API manufacturing perspective there are no differences between the manufacture of a product with CBD and a traditional manufacturing process of a small molecule.
The development and manufacture of this drug substance will occur across Lonza’s global network, including its sites in Nansha, China, Edinburgh, UK, and Ploermel, France. Because of this globalization, the development and manufacture of the drug is more accessible, “Depending on the approving authority or country regulations, some CBD-based medicines may be classified as scheduled drugs – in this case, we have sites within our network that can handle controlled substances,” said Dowdeswell
He further explained that most CBD-based molecules show poor bioavailability which in turn means that high dosage forms of the product may be necessary, “the option of a soft gel as a dosage form is particularly advantageous in this class of drug.”
Cannabinoid-based drug research
Emerald Health has been researching the use of cannabinoid-based drugs for the treatment of diseases such as multiple sclerosis (MS), systemic sclerosis (SSc), Huntington’s disease, and Parkinson’s disease.
Jim DeMesa, CEO of Emerald Health said in a statement, “We firmly believe that novel cannabinoid-derived molecules with a unique combination of pharmacological properties have the potential to be developed into safe and effective prescription drugs that can be of great benefit in treating patients with life-threatening diseases that currently have no cure.”
With this agreement, the development and future commercialization of cannabinoid-based medicine for therapeutic applications are more accessible. “This agreement with Lonza will help us meet this vision,” said DeMesa.