Virdante Pharmaceuticals has signed on ProBioGen for its expertise in developing royalty-free pharmaceutical cell lines and robust, economical processes for GMP-manufacturing. ProBioGen will contribute producer cell-line development and process engineering for one of Virdante's therapeutic proteins.
In addition to its CHO platform, ProBioGen has developed AGE1® producer cell lines for safer and more cost-efficient production of highly active glycoproteins, mAbs, and virus-based vaccines.
Virdante reports that its protein products are unique in that they incorporate the company's Sialic Switch technology, which has been designed to improve anti-inflammatory properties of an antibody for autoimmune and inflammatory diseases.
The platform is based on the observation that pooled polyclonal IgG from thousands of donors (intravenous immunoglobulin, or IVIG) is often used at high doses to treat a wide variety of autoimmune diseases. The company demonstrated that the anti-inflammatory activity of IVIG results from a minor population of the pooled IgG molecules that contains terminal alpha 2,6-sialic acid linkages on their Fc-linked glycans.
Virdante further showed that these anti-inflammatory properties can be recapitulated with a fully recombinant preparation of appropriately sialylated IgG Fc fragments and that these sialylated Fcs specifically bind to a C-type lectin, DC-SIGN.
Virdante is leveraging this naturally occurring anti-inflammatory pathway to develop antibody and Fc-fusion drugs by enzymatically sialylating the Fc-linked glycans. Virdante is taking advantage of preclinical data on the active ingredients present in currently marketed IVIG drugs and is developing manufacturing processes to advance its drug candidates to the clinic.