Immunology and Biotherapies

Product and Process Innovation in the Development Cycle of Biopharmaceuticals #biologics #biologicals mAbs #biopharma
http://t.co/yV97kw0IAy

 

Summary: Compared to small-molecule drugs, biopharmaceuticals require significantly more complex processes for R&D and production. In this work, we tracked and categorized patented biopharmaceutical technologies along the innovation cycles timeline using International Patent Classification (IPC) codes to show that the biopharmaceutical R&D process has been evolving from the conventional pattern of innovation. Our study builds on the latest research on innovation theories to provide empirical evidence that demonstrates reshaping of innovation processes through utilization of scientific knowledge. Based on our results, we provide strategic perspectives on the biopharmaceutical industry.

 

Teaser: We tracked and categorized patented biopharmaceutical technologies along the innovation cycle timeline using IPC codes to show that the biopharmaceutical R&D process has been evolving from the conventional innovation pattern.

Via Krishan Maggon

The development of complex biosimilars, such as monocolonal antibodies and fusion proteins, is an exceptionally challenging technical undertaking.  Unlike traditional small molecule pharmaceuticals which are essentially formula driven chemicals, complex biologics are much larger, multifaceted molecules.  To illustrate the relative levels of complexity, a traditional aspirin molecule can be likened to a bicycle, while a simple biologics (such as human growth hormone) can be likened to an automobile.  A complex biologic, such as a monoclonal antibody (mAb), meanwhile, is analogous to a modern commercial airliner.

 

Due to the complexity of mAb’s and fusion proteins, the requirements for establishing that a biosimilar molecule is biologically comparable to the original innovator molecule require comprehensive and exquisite science. The BioSymphony model for biosimilars development was specifically designed to address those scientific and regulatory requirements, within a framework of rapid, low-cost, high quality execution, as illustrated below.

 

  

© 2015 Oncobiologics, Inc.

 

 

Via Krishan Maggon