Daicel Chemical Industries, Ltd. and Groupe Novasep SAS, announce the formation of a strategic technical co-operation aimed at streamlining the use of chiral chromatography to manufacture late-stage clinical and commercial chiral intermediates and APIs.
Under the terms of the agreement, the companies will cooperate to develop solution for the manufacture of chiral compounds for customers in the pharmaceutical industry.
Daicel and its subsidiaries, Chiral Technologies Europe SAS and Chiral Technologies Inc., will identify the best chiral stationary phase from their library of commercial and developmental chiral stationary phases (CSP's).
Novasep Process will provide process optimization services, using its computer simulation software and full process development with its advanced technologies such as Varicol® continuous chromatography process. The intended result of this combined approach is to deliver guaranteed scale-up, optimum performance and best economics for large-scale separations.
"Today, several chiral drugs are commercially produced at tons to 100's tons scale with chromatographic technologies. Such drugs include Pfizer's Zoloft®, UCB Pharma's Keppra®, Lundbeck's/Forest Laboratories' Cipralex®/Lexapro®, and Cephalon's Nuvigil™" says Jean Blehaut, President of Novasep Process' Pharma Business Unit.
"But the pharmaceutical industry is just discovering the potential of chiral chromatography to bring NCEs to the market faster. The existing commercial projects have demonstrated that it is often cheaper to produce single enantiomeric drugs with chromatography rather than use traditional technologies such as crystallization and/or asymmetric synthesis.”
Jean Blehaut continues: "The time is right to join forces in the field of large scale chiral chromatography to more rapidly develop this technology for the industry".
"The idea of our cooperation is quite simple: we are proposing our current and future customers to obtain all the required process and method data whilst maintaining the single point of contact of their choice, either Novasep or Daicel": states Dieter Heckmann, CEO of Chiral Technologies Inc. and Chiral Technologies Europe. "Each company will apply its core technical skills to develop a single solution to meet short and long-term objectives for each project."
The customer will be presented with the combined data to make an informed decision. The proposed production process (chromatographic system and CSP) will have a guaranteed performance and will include all applicable licenses to Novasep and Daicel's intellectual property.
In combination with a network of Chiral Technology Laboratories, who have in excess of 20 years experience in the manufacturing of stationary phases and an extensive knowledge in large-scale chiral separations, Daicel ensures global support for the isolation of chiral pure compounds, (Chiral Technologies Inc., USA, Chiral Technologies Europe SAS, Daicel Chiral Technologies China and Daicel Chiral Technologies India).
The Chiral Technology laboratories offer local technical assistance, supply from stock and complementary support services to ensure an increasing use of chiral chromatography in the pharmaceutical and biotechnology industries. Daicel products are the industry leading chiral chromatographic phases and are used in the majority of pharmaceutical laboratories and production plants worldwide.