By CERBIOS-PHARMA SA
Cerbios-Pharma SA HPAPI and ADC payload manufacturing capacity expansion
Lugano, Switzerland: – Pharmaceutical ingredient and-CDMO specialist Cerbios-Pharma SA (Cerbios) has announced that regulatory agency SwissMedic has approved its new production facility dedicated to the GMP manufacturing of clinical and commercial highly potent molecules.
HPAPIs produced at the new facility will include cytotoxic linker-payloads for ADCs antibody drug conjugates used in anti-cancer therapies.
State of the art containment
The plant is located in a new building at the Cerbios headquarters site at Lugano that features two cGMP manufacturing lines equipped with state-of-the-art isolator containment technology to handle highly potent molecules with containment levels below 10 ng/m3 (OEB 6).
The facility is designed and configured to meet the current market needs in Oncology and particularly in the ADC production space where development of molecules require technologies such as high- and low-pressure chromatography, nanofiltration and freeze drying. Built to host dedicated and single use reactors up to 100 L, the line’s adaptable capacity will handle batches from grams up to kg scale covering clinical and commercial stages.
The regulatory authorization marks the latest milestone in Cerbios’ recent campaign of investment in expansion of its advanced contract development and manufacturing (CDMO) services promoted mainly through its Proveo™ division, -the one stop shop for ADCs manufacturing.
Cerbios-Pharma Chief Commercial Officer Denis Angioletti commented: “This new building is a result of our long-term strategy in growing in a sustainable manner, with the commitment to provide high quality CMO services, advanced technologies and strong know-how for our valued customers, consolidating our position as one of the leading companies in the highly potent and cytotoxic molecules space.”
“We are very proud of this achievement, and we are confident that the increased capability opens to new cooperation opportunities in HPAPIs and ADCs commercial fields,” Mr. Angioletti added.
Cerbios is a privately held company located in Lugano, Switzerland, specialized in different areas: manufacturing pharmaceutical active ingredients (Drug Substances), offering CDMO services and manufacturing Finished Pharmaceutical Forms based on its proprietary probiotic strain SF68®.
Cerbios is the ideal CDMO partner from clinical to commercial supply of API, HPAPIs, Payloads, ADCs, Proteins and Antibodies.
Cerbios is also a global leading supplier of a portfolio of Generic APIs primarily used in Oncology and for the treatment of Respiratory and Dermatological disorders.
Cerbios has additionally a 40 years’ experience in the probiotics field: the portfolio includes a FDF based on proprietary strain SF68® for treatment of diarrhea and dysbiosis by antibiotics and a new Food Supplements line.
Learn more at: https://cerbios.ch