First cGMP batches of omega-3 drug processed for Phase III trials.

Acasti Pharma announced the achievement of a corporate milestone by manufacturing the first cGMP batches of CaPre, the company’s omega-3 product candidate via a “proprietary and innovative” continuous manufacturing (CM) process developed with Corden Pharma. According to Acasti, its product is a potentially best-in-class therapy for patients with hypertriglyceridemia, a metabolic condition associated with cardiovascular disease and pancreatitis. Acasti now joins a growing but small club of drug owners/developers like Janssen, the subsidiary of Johnson & Johnson, in announcing the application of CM techniques to manufacture their therapeutic agents and compounds.

CaPre, said Acasti, is derived from krill oil. The CM process will increase throughput and provide a smaller process line footprint for manufacturing at the Corden Pharma Chenôve facility in Dijon, France. Acasti’s process, designed jointly with engineers from Corden Pharma, will purify the bioactive molecules of the raw krill oil. The companies said the approach will yield improved quality control, reduce energy consumption and waste, while improving resource efficiency and compliance cost-effectively—all of which aligns with “the FDA’s championing of robust, flexible and efficient continuous manufacturing processes.”

Describing the joint venture as highly successful, Pierre Lemieux, Chief Operating Officer of Acasti Pharma said, "The development and implementation of this continuous manufacturing production line is evidence of the terrific progress Acasti is making as we prepare to initiate Phase 3 trials of CaPre in late 2017." Cordon Pharma worked closely with its clients, said Yves Michon, Chief Executive Officer of Corden Pharma Chenôve, “to design and engineer a unique and innovative continuous manufacturing process for CaPre … {one that} will allow us to efficiently scale-up the volume of CaPre needed for Acasti's Phase 3 trial and early commercial demand."

Since its founding in 2008, Acasti Pharma said it has been focused on addressing the critical market need for an “effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk.” For its part, Corden Pharma is the global manufacturing and services provider for the International Chemical Investors Group (ICIG), providing contract manufacturing and development of drug products APIs and packaging, through a network of cGMP facilities across the US and Europe.