GMP Production

Celonic is specialized in the production of recombinant proteins in eukaryotic expression systems in all development stages e.g. proof-of-concept studies (research), preclinical (non-GMP) and clinical studies (GMP). Besides, Celonic offers solutions for a complete process development of biopharmaceuticals.

We offer:

• Production of e.g. antibodies, fusion proteins, cytokines, biosimilars …
• Production in each scale up to market demands
• Procedures for the cultivation of adherent and suspension cells
• Experience in the cultivation of a large number of eukaryotic cells e.g. CHO, HEK293, HeLa, NS0, NS1, SP2.0, ...
• Cultivation in different types of bioreactor systems: Wave-bioreactor (20, 50, 1.000 liters) and stirred vessel (up to 300 liters)

All of these cultivation systems may be operated in batch, fed-batch and continuous perfusion mode to achieve the optimal space/time yield for each process. Celonic has the facilities to chill the temperature sensitive medium as well as the product during the continuous fermentation to avoid loss of qualities. Subsequent product purifications are achieved in our downstream process area.
> Downstream Processing

The GMP production is completely performed in our Basel facility certified by SwissMedic for the production of biopharmaceuticals for clinical studies and market supply.
> Basel Facility

Under non-GMP conditions, we apply all established fermentation systems (stirred vessel, wave bioreactor, fluidised bed bioreactor) and - during development - several state-of-the-art cultivation systems like 32-fold parallel spinner systems. They enable the cultivation of animal or human cells under optimal conditions. The choice is dependant on our customers’ preferences. All systems are combined with process control units that allow the cultivation of animal and human cells under optimal conditions. Due to the high space-time yield of continuously operated processes Celonic is poised to produce monoclonal antibodies and recombinant proteins quickly and cost effective.

Celonic offers individual, customer specific solutions for the production of recombinant proteins, starting at proof-of concept experiments. We provide solutions on flexible production platforms:

• Production processes adapted to the needs and specific productivity of the particular cell line
• Production of sufficient amounts of recombinant proteins even from low-producer cell lines by virtue of the high cell density fluidised bed bioreactor technique