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Emerald Health, Lonza Enter Large-Scale Mfg. Pact

Lonza will synthesize the API drug substance and develop the CBD drug product as liquid-filled capsules

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By: Kristin Brooks

Managing Editor, Contract Pharma

Emerald Health Pharmaceuticals and Lonza have entered an agreement for the large-scale manufacturing of a new synthetic derivative of cannabidiol (CBD) and its oral drug product for the treatment of multiple sclerosis (MS) and systemic scleroderma, also known as systemic sclerosis (SSc). Lonza Pharma & Biotech will synthesize the API drug substance (VCE-004.8) and develop the drug product (EHP-101) as liquid-filled capsules.
 
The development program will utilize Lonza’s global network: API (VCE-004.8) process development and cGMP manufacturing at its Nansha site, which recently concluded a successful general U.S. FDA inspection; liquid-filled hard capsules at Lonza’s Edinburgh site; soft gel capsule drug product development and manufacturing at Lonza’s Ploermel site. A dedicated program manager will coordinate the activities at the three sites.
 
“As Emerald Health Pharmaceuticals advances through clinical trials, we will be supporting them with an integrated API and specialized liquid encapsulation solution,” said Christian Dowdeswell, Ph.D., head of dosage forms & delivery systems, Lonza Pharma & Biotech. “Patients will benefit from cGMP-quality therapies in an accessible and efficient format.”
  
“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,” said Jim DeMesa, MD, chief executive officer of Emerald Health Pharmaceuticals. “This agreement with Lonza will help us meet this vision.”

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