Rheumatoid Arthritis

Rheumatoid Arthritis - API Product PB (RA) - 2010 & Biosimilars Technology

PB-RA-2010 is soon to be off patent involving biosimilars API / biosimilars technology for the production of recombinant human Interleukin-I receptor-antagonist protein. The product is used for the treatment of Rheumatoid Arthritis (RA). PB-RA-2010 is a biosimilars molecule that works as part of a group of recombinant products by blocking the biological activity of the IL-I receptor. IL-I is a key mediator of inflammation and a driver of auto inflammatory diseases in both adults and children.

PB-RA-2010 is a recombinant non-glycosylated version of IL-IRA produced in genetically modified E. Coli using recombinant DNA technology. It consists of 153 a.a. and possesses a molecular mass of 17.3 KDa. As a biosimilar, it is an approved therapy for RA.

Paras Biopharmaceuticals Finland Oy has successfully achieved a very high expression of the Biosimilar Rheumatoid Arthritis product.

Product status	SDS-PAGE High expressions » Separation and purification of Diabrid achieved. » Confirmation through mass spectrometry. "Very high yield of product achieved - multiple grams per liter yield of purified material."
Technology status		Technology ready to be out licensed for scale up production. Recombinant stable E. Coli Clone exhibit deposits of the Rheumatoid product inside the cells (EM@39000-Paras Rights Reserved). SDS-PAGE-Gel image (left) showing marker (lane1), homogenization broth (lane2) and separation of product (lane3). Lane 4 and 5 show the purified product.
		Mass spectrometry (MS) data ( left side) shows confirmation of the correct product. Very high yield of product achieved - multiple grams per liter yield of purified material.