Production of cGMP mAbs and Recombinant Proteins: Successful Swissmedic inspection
Cerbios-Pharma SA (www.cerbios.ch) is pleased to announce that Swissmedic has successfully inspected the brand new plant for biopharmaceutical active ingredients based on recombinant DNA technology for the manufacturing of mAbs and recombinant protein cGMP clinical batches. The plant has been confirmed to be suitable for commercial production in the future, subject to successful installation and qualification of additional equipment following the next expansion phase.
“We are all very happy about the outcome of a very intensive 5 day audit and inspection by two Swissmedic inspectors.” confirms Dr. Gabriel Haering, Cerbios CEO.
“The project started when I joined Cerbios in 2009 where there was good expertise at R&D level for mammalian cell culture (CHO) up-stream and down-stream processes, but with only an R&D infrastructure.Since Cerbios’ core business is cGMP production for clinical trials and commercial supply, we have intensively worked in order to set up a state-of-the-art cGMP production unit on the basis of the long-term experience Cerbios has in biotechnology and fermentation."
The project has taken over three years, from its conception to realization, and several million Swiss francs.
The production unit is ideal for:
- Preclinical or clinical material manufacturing
- Orphan drugs NBEs (recombinant proteins or mAbs)
- mAbs intended for coupling with cytotoxic payload for ADC (antibody-drug-conjugate) production
After the move of the actual R&D laboratories to their new building the space left empty has already been conceived and set up for a second production line (up-to 1,000 Litre fermentor) with either stainless steel or disposable fermenters.
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.