Cerbios-Pharma Investing in New High-Potency API Production Line and Conjugation Suite
Cerbios-Pharma SA 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:
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:
- two ranges of operations for conjugation(1–20 liters/batch [glass reactors] and 50–200 liters/batch [disposable technology]
- tangential flow filtration (TFF) isolation with disposable parts
- capabilities for OEL-granted SafeBridge Category 4 (< 5 ng/cubic meter)
- 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.
The original text of the announcement written by Patricia Van Arnum, DCAT Editorial Director, can be found by clicking here.
Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.