Swissmedic approves new Cerbios-Pharma HPAPI Production Plant

news-releasesCERBIOS-PHARMA SA
August 6th 2021

Lugano, Switzerland: – Pharmaceutical ingredient specialist Cerbios-Pharma SA (Cerbios) has received approval from the Swissmedic regulatory agency for its new manufacturing unit, which forms the latest addition to its plans for expansion of its manufacture of highly potent active pharmaceutical ingredients (HPAPIs) and drug substances.

This new production line at Lugano is dedicated to highly active products with containment allowing occupational exposure limits (OEL) as low as 30 ng per cubic meter and enabling manufacture up to 35 kg batch size. Featuring reactors up to 1000 L and pressure-filter-dryers, the new plant will extend Cerbios manufacturing capacity and complement its existing HPAPI facilities with an expanded range of batch sizes and services.

Cytotoxic payloads for ADCs

The recently introduced equipment amplifies the company’s know-how in technologies such as preparative purification at medium/high pressure and nanofiltration, key for the manufacture of HPAPIs and cytotoxic payloads used in antibody drug conjugates (ADCs).

Cerbios-Pharma CEO, Christian Suà, commented: “With these implementations, Cerbios is continuing its program of investments and expanding its offer of CDMO services for the manufacture of highly potent drugs, which represent one of the strategic cores of our business.”

About Cerbios-Pharma

Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacturing of both chemical and biological APIs for its partners world-wide.

Exclusive CDMO services are offered for the development and manufacturing of high potency active ingredients (HPAIs) as well as for biological products including monoclonal antibodies, recombinant proteins and antibody drug conjugates (ADCs).

Cerbios provides full CMC support, including the supply of cGMP clinical batches, registration/validation materials and commercially manufactured APIs, with paramount ability to support a successful registration. Cerbios is a worldwide presence with partners in Europe, USA and Japan.

Cerbios Division, PROVEO™, in partnership with AGC Biologics and Oncotec, focuses on integrated ADC manufacturing solutions, offering an end-to-end ADC service from drug substance development to sterile Fill & Finish.

PROVEO provides a complete service platform for the development and manufacturing of ADCs and each component.

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Swissmedic approves new Cerbios-Pharma HPAPI Production Plant

The newly approved Cerbios-Pharma HPAPI production facility features high containment, advanced reactors and pressure-filter drying to extend batch manufacturing capabilities for cytotoxic payloads.