Marc-Olivier Simon
Project Manager

Ypso-Facto
Tour Part-Dieu, 129 Rue Servient, 69326 Lyon Cedex 03, France

Co-author: 

Roger-Marc Nicoud – President and CEO Ypso-Facto, 10 Viaduc John F. Kennedy, 54000 Nancy, France

Abstract

The fine chemicals segment is a field of continuous innovation with regards to new molecular structures in which Contract Manufacturing Organizations (CMOs) play a major role, in particular for the commercial-scale production of organic molecules. To face constant international competition, these front-line players need to identify those sound developments that will allow them to remain on the cutting edge of technology. However, defining the right scientific and technical strategy among the wide flow of advances published in the literature is like looking for a needle in a haystack. As a service company providing support to chemical and biochemical firms for the development of their products and processes, Ypso-Facto has developed significant experience in that field. We present a structured yet flexible methodology that is likely to help find the needle(s), with the aim to reinforce the CMO’s attractiveness and competitive edge.

INNOVATION IN THE FINE CHEMICALS INDUSTRY

The fine chemicals industry is generally defined as the business sector bringing together chemicals with low volumes and high-values that are selected on the basis of targeted molecular properties. The end-markets are diverse as fine chemicals serve pharmacy, agrochemistry, cosmetics and electronics. Another important feature of this sector is the constant innovation in products with the emergence of new chemical structures and the renewal of a significant number of old ones. As an example of this trend in the pharmaceutical industry, FDA’s Centre for Drug Evaluation and Research (CDER) approved 33 new molecular entities (NMEs) under new drug applications (NDAs) in calendar year 2015 and 30 in calendar year 2014, far above the average approvals of the last ten years (1). Interestingly, 21% of the NMEs approved in 2015 were first-in-class. This relentless need and rush towards new structures, combined with ever-changing economic and regulatory constraints, leads to the continuous evolution of the technologies to manufacture fine chemicals.

CONTRACT MANUFACTURING ORGANIZATIONS AND T ... ...