Recombinant Proteins
Biological Division
Recombinant technology allows for the production of proteins such as enzymes, antibodies or hormones using molecular and cellular biology tools. Basically, a gene coding for an interesting protein of a certain organism is transferred into the genome of a cell that may be cultivated. The modified cell, now called “recombinant”, is expanded into a cell line that can, if suitably engineered, secrete the recombinant protein of interest.
The advantage of recombinant technology compared to the classical production of proteins from extractive fluids or tissues resides in a better standardisation of the protein quality and the independence from sourcing of biological materials suitable for extraction. Since the breakthrough in recombinant DNA technology and first approvals of human medicines in the early eighties, recombinant DNA technology has been very much developed. Eukaryotic cell lines, such as CHO, have been introduced instead of bacterial cells in order to obtain proteins which are glycosylated as proteins naturally are.
Since 1976 Cerbios has gained a vast experience in large scale microbial fermentation for the production of probiotic active ingredients up to the 4000 L scale. Based on this expertise, in 1994 Cerbios started developing platforms for the production of high quality recombinant proteins of therapeutic interest. The most interesting know-how of Cerbios in this field today resides in mammalian cell cultures up to 100 L bioreactor scale under cGMP, dedicating particular attention to ensuring quality, purity and safety during development and manufacturing. Thus, completely synthetic cultivation media are used without addition of serum or proteins and without creating selective pressure by the addition of antibiotics. Harvesting systems and strategies for downstream protein purification have been thoroughly developed, along with strong analytics of biological products, needed for testing activity and stability toward storage and stress conditions.
Biologics keep gaining importance in the global pharmaceutical market. Besides premium priced novel therapies for conditions that cannot be managed by conventional drugs, the gradual expiry of patents is expected to create significant market opportunities for biosimilars. Cerbios is prepared to serve the industry with such active ingredients according to the highest quality standards and in full compliance with cGMP requirements.
The first two recombinant proteins developed for our product pipeline with our CHO platform are Recombinant Urokinase and Recombinant G-CSF. Other projects for third parties were introduced and successfully developed. Cerbios is offering its know-how and expertise offering services for development and manufacturing for third parties.
