Phase I

In cases where a particular product requires a high dose or otherwise has a large API requirement, Fermion will get involved for earlier stage products.  Otherwise, for small scale API manufacturing, Fermion will typically look to its network of outside laboratories.

The development process often begins with a Retrosynthetic analysis of a product (unless an established manufacturing route is available from the customer). Fermion begins with the target molecule and works its way back to commercially available intermediates.  Very often, several route options are available.  Fermion then evaluates each of the route options and estimates their cost.
Next, the different routes would be tested in the lab, documented and evaluated for cost. Preliminary Safety/Health/Environment studies would also be initiated at this stage. 

The route selection for larger-scale manufacturing would be based on the outcome of these studies. Fermion manufactures these compounds under cGMP, in full compliance with ICH-Guidelines. 

 

 


 

 

Updated Jan 26th 2010