Partner network for early intermediates and release philosophy

Fermion understands itself as a provider of different services, where the level and amount of service needs to be decided on a case by case.

Economic aspects are very important in API-manufacturing, as the costs of an API often dominate the cost structure of a given drug product. It is for this reason that process development is a permanent task. The word “economic” not only refers to costs, but also refers to the sustainability of a process, including maintaining its robustness, and maintaining control of environmental impact and raw materials used. In this respect, we emphasize co-operation scenarios which allow a reasonable cost structure while maintaining quality, reliability of supply and compliance with regulatory aspects.

In order to achieve this, Fermion has established a network of partners with whom it can source critical intermediates by tech transfering a process developed by Fermion, agreeing on release specifications and entering into Supply Contracts, very often complemented with Quality Agreements. Fermion embraces co-operation rather than confrontation with suppliers located in Asia. It actively screens and audits potential suppliers for regulatory compliance and targets mutually successful co-operation scenarios.

The scheme below illustrates the functionality of these co-operation scenarios. In these cases, Fermion can release intermediates made by outside plants according to its own internal specification while still capitalizing on speed and cost savings. 

 

Partnership diagram

 

API Supply chain

Updated Feb 16th 2010