Synageva Expression Platform

The Synageva Expression Platform (SEP™) is a novel, integrated platform of proprietary vectors and protein production, processing and purification systems. The SEP™ is in many ways superior to current expression methods with respect to productivity, having achieved industry leading expression levels for several protein therapeutics including certain lysosomal enzymes, cytokines, and fusion proteins. In addition, SEP™ has the ability to produce biotherapeutics with advantageous glycosylation patterns including:

• Monoclonal antibodies (mAbs) with significantly enhanced ADCC (antibody dependent cellular cytotoxicity)
• Biotherapeutics with glycosylation patterns tailored to enhance targeting to specific disease tissues

SEP™ also offers key advantages with regards to cost, scalability, and consistency of end product. SEP™ has achieved regulatory validation through three Phase 1 clinical trials and one Phase 2 multi-center global clinical trial.  

The foundation for the SEP™ is our proprietary vector technology. Synageva's research team continues to make unprecedented scientific advances such that our vectors have achieved protein expression at up to ~14 grams/liter. A wide variety of proteins have been expressed through the SEP™ including monoclonal antibodies, fusion proteins, cytokines, and therapeutic enzymes.

The process begins as our team designs constructs comprised of the sequence for the human biopharmaceutical protein of interest, inserted alongside a customized, tissue-specific promoter. Once this construct is introduced into our clinical production lines, large quantities of the protein of interest are expressed in egg white (EW). Since EW is a protein-friendly environment with no DNA or lipids, the protein remains very stable. Through robust, highly scalable, fully GMP compliant processes, unpurified bulk is extracted and the human biopharmaceutical protein is purified and fill/finished to ensure high quality biopharmaceuticals are readily available for our clinical programs.

From the time the construct is created in vitro, pre-clinical quantities are available in less than 6 months and commercial scale quantities can be reliably delivered in less than 24 months.

COMPARING EXPRESSION SYSTEMS