Cerbios-Pharma Investing in New High-Potency API Production Line and Conjugation SuiteBy
Cerbios-Pharma SA, a Lugano, Switzerland-based contract development and manufacturing organization of chemical and biological active pharmaceutical ingredients (API), is expanding its high-potency API (HPAPI) production and conjugation capabilities. Gabriel Haering, Chief Executive Officer, Cerbios-Pharma SA, outlined the expansion at the DCAT Week ’19 Member Company Announcement Forum, which was held March 18, 2019 in New York.
Haering noted that Cerbios’ Board of Directors approved in 2018 large investments to expand the company’s capabilities and capacity for HPAPI production. The largest investment is for approximately $5.5 million for a large-scale HPAPI production line for SafeBridge Category 3 and 4 potent compounds (occupational exposure limits [OEL] < 30 ng per cubic meter). The production line will produce either HPAPIs for third parties or potent advanced intermediates. The new production line is due in the fourth quarter of 2020.
The production line will include the following: (1) a dispensing glove box; (2) two Hastelloy reactors (630 and 1,000 liters), each one equipped with its own charging glove box; (3) an Hastelloy pressure-filter-dryer with discharging glove box; (4) temperature ranges (-25 to 130 degrees Celsius), upgradable in the future (-60 to 160 degrees Celsius); and (5) operating pressure up to 6 bar. The dry-powder batch size will range from 5 to 35 kgs/batch.
Haering also outlined the company’s new antibody drug conjugate (ADC) conjugation suite at the company’s facility in Lugano, Switzerland. The board approved an investment to create a new dedicated suite for conjugation in 2018 due to increased demand for projects requiring conjugation and demand for material for more advanced clinical phases in all areas (toxins, other HPAPIs, and conjugation). Cerbios has a single site (Lugano) for production of biotechnology products (monoclonal antibodies and recombinant proteins) as well as HPAI and small-molecule cytotoxic compounds and conjugation.
The new conjugation suite will consist of the following: (1) two ranges of operations for conjugation(1–20 liters/batch [glass reactors] and 50–200 liters/batch [disposable technology]; (2) tangential flow filtration (TFF) isolation with disposable parts; (3) capabilities for OEL-granted SafeBridge Category 4 (< 5 ng/cubic meter); and (4) Class C with a dedicated heating, ventilation, and air conditioning (HVAC). The suite will be ready and qualified for cGMP productions during the third quarter of 2019. Total investment, including the building, utilities and equipment, corresponds to $2.5 million.
Overall, the company has invested more than $30 million as part of a multi-year investment plan in HPAPI production.