Roman T Drews
LFB, USA
Title: Production of Biosimilar MAbs in Transgenic Animals– Opportunities and Challenges
Biography
Biography: Roman T Drews
Abstract
Expression of recombinant proteins in the milk of transgenic dairy goats has been established asa viable and cost- effective alternative to mammalian cell culture systems. The first transgenically produced therapeutic protein, recombinant human Antithrombin (ATryn), has been approved by the European authorities in 2006 and by the FDA in. 2009. Since then it has been successfully used to treat patients with hereditary deficiency of antithrombin. Due to the high capacity of the mammary gland for protein expression and milk output, the transgenic system is particularly suitable for production of complex proteins in large quantities. This production system and large capacity for recombinant protein expression has been put to use generating monoclonal antibodies to develop several biosimilar products that will be described herein. This presentation will specifically explorethe scientific and regulatory pathwayfor the development of therapeutic monoclonal antibodies (MAb)expressed in the milk of transgenic animals under the provisions of the Biologic Price Competition and Innovation Act of 2009 (BPCI Act)
