*STEPHEN CLOSS¹, GAVIN MURDOCH²
*Corresponding author
1. Thermo Fisher Scientific, Whitby, ON Canada
2. Thermo Fisher Scientific, Durham, USA

Abstract

Evolving industry requirements have moved Contract Development and Manufacturing Organizations (CDMOs) beyond traditional capacity and supply chain extension models that were their original foundation into partnering solutions providing technical guidance and leadership to small and large pharma customers.
Novel technology development is one area where new business models are being explored whereby companies partner with CDMOs to learn, develop, and employ new technology platforms to advance the development and commercialization of pharmaceutical products. Past innovation and novel technology programs were usually developed in-house or by acquisition.
Now pharmaceutical companies are looking to CDMOs as a lower risk option to accelerate development, adoption and realize potential quality, cost, and timeline benefits that evolve from strategic partnership.

CDMO BACKGROUND AND EVOLUTION
The evolution of the Contract Development and Manufacturing Organization (CDMO) has seen dramatic changes since stepping onto the pharmaceutical scene at the end of the 20th century. At the onset, contract organizations and the state of the pharmaceutical world were far different from the models operating today. Big pharma owned a majority stake in all areas of the drug lifecycle-- from discovery, to early development, clinical phase and programs, process and product technology development and innovation, supply chain management, and commercial manufacturing. Most companies’ product pipelines were focused on large volume commercial blockbusters that could support and fund a large technical workforce that focused mainly on new product development and commercialization. At that time regulatory practices were somewhat static and the legacy processes and products could be manufactured, as validated, without change for many years and with little requirement for continuous improvement or refinement to improve pharmaceutical methodologies and processes.
New technology development and innovation was mainly conducted within ...