Cerbios-Pharma SA (hereinafter referred to as "Cerbios") is a Swiss privately held company located in Barbengo/ Lugano, Switzerland, specialized in the development and manufacturing of chemical and biological APIs and HPAPIs for its partners world-wide. cGMP APIs and HPAPIs manufactured by Cerbios consist of small molecules, large molecules and Probiotics sold to pharma companies in highly regulated markets like Europe, North America, and Japan as well as in many other countries in South America and the Far East.
CDMO services for development and manufacturing of HPAPIs, ADCs and Recombinant Proteins cover all product lifecycle up to clinical and commercial supply.
Quality & Regulatory
The company cGMP quality assurance platform is based on international standards (e.g. ICH, PIC).
Cerbios quality system supports partners with the registration of NCEs or NBEs at the US-FDA, EMEA, PMDA and other regulatory agencies.
Cerbios holds several active DMFs (US, EU, JPN) in CTD format and is regularly inspected by its partners, and authorities. The Swissmedic and the US-FDA inspections fully confirmed the state-of-the-art level of its quality system.
The site has also received full accreditation from the Japanese PMDA.