Symphogen has developed a proprietary expression platform called Sympress™, which enables the Company to produce antibody mixtures in a single bioreactor in a consistent and reproducible manner. Sympress™ is based on mammalian expression technology, and uses the well-characterized stable and robust Chinese Hamster Ovary (CHO) to generate stable antibody-producing cell lines. The established technology platform makes it possible to maintain diversity and obtain batch-to-batch consistency of antibody mixtures while keeping developmental costs to a level similar to monoclonal antibody developmental costs.
A complete Sympress platform manufacturing, release and characterization procedure has been established. The process involves culturing a mixture of stable cell lines, each of which expresses one distinct antibody. A two-tiered cell banking concept ensures consistent manufacturing throughout product life-span. The upstream manufacturing process is based solely on chemically defined reagents and has been designed to enable generation of reproducible and controlled antibody compositions. Likewise, the platform downstream manufacturing process has been designed to maintain the exact same antibody composition that was harvested from the bioreactor. The Sympress™ technology also includes novel protein assays developed for appropriate quality control, release and characterization of this new class of drugs as needed for regulatory approval.
Symphogen has demonstrated proof-of-concept for the effective utilization of the Sympress™ manufacturing platform for multiple internally developed products and obtained regulatory buy-in to the technology. Two of the products are currently being tested in clinical trials in the US and EU. Besides Symphogen has issued and pending patents covering the production of recombinant antibody mixtures.
