Wyeth and Ambion RNA Diagnostics, a division of Ambion Inc, The RNA Company, have entered into a development and supply agreement, under which Ambion RNA Diagnostics will develop and manufacture cGMP-grade RNA for Wyeth.
The agreement represents a major step toward Ambion''s goal of leadership in the field of contract RNA services for pharmaceutical and in vitro diagnostics applications. Under terms of the agreement, Ambion RNA Diagnostics will optimize processes for the synthesis of long RNA molecules and efficient translation of the RNA into protein. Ambion will subsequently manufacture these RNA transcripts under cGMP quality requirements, for use as a component in Wyeth''s innovative vaccine program. Manufacture will be on a scale to meet Wyeth''s needs for clinical trial material.
Ambion RNA Diagnostics was created to provide RNA-based products and services to the in vitro diagnostic and pharmaceutical processing industries. Ambion''s state-of-the-art molecular biology laboratory is a cGMP multi-user, multi-product facility, which includes fully equipped QC, process and product development laboratories. The facility is available on a contract- manufacturing basis to provide RNA synthesis, RNA isolation, diagnostic kits, controls and standards, and RNA-based raw materials for bioprocessing applications.