Follow-On Biologics

Applying Innovative Science to the Development of Interchangeable Biologics

 

Momenta’s follow-on biologics (FOB) program further extends our technology to include the characterization and engineering of therapeutic protein products. Therapeutic proteins represent a significant and growing segment of the U.S. drug market. Momenta is working to apply its deep expertise in many disciplines to derive the structure of complex proteins and link the structural signatures to specific manufacturing process parameters. Furthermore, we couple the structural characterization with biocharacterization methods, based on our understanding of the product’s biology, to obtain a thorough analysis of our FOB in relation to the branded biologic.

 

Many of the currently approved therapeutic proteins have not been fully characterized due to limitations of past technologies. Using Momenta’s suite of technologies, we seek to achieve a deeper understanding of the relationship between the multiple manufacturing process steps and the final product composition of these proteins, which are derived from natural or cell-based manufacturing processes. The goal for our FOB program is to replicate our success in characterizing and developing enoxaparin sodium injection and to pursue development and commercialization of interchangeable biologics.

 

Last revised 6/21/2012