While the focus at lab scale is verifying a specific process to be transferred, Fermion will now concentrate developing a suitable manufacturing process on the bench scale.

This step comprises a multifaceted approach with a wide variety of disciplines:

a) Organic chemists will discuss several approaches with our customers allowing manufacturing on larger scale with the potential for further expansion to validation and commercialization.
b) Analytical chemists will investigate the process from an impurity point of view and suggest specifications for the drug substance, intermediates and raw materials. Their work will be followed by validation of the methods of analysis.
c) The process will be reviewed with respect to safety aspects, its impact on the environment, the REACH-legislation and permits required, and, very important, the economics involved.
d) Chemists in regulatory affairs will define strategies for the compilation of the Drug Master File.
e) Last but not least, sourcing specialists will review the market for suppliers of intermediates and/or raw materials and select them after purchase specifications and other commercial aspects are agreed upon.

Fermion defines the deliverables of  “Product Concept 2” as a report on the tests and limits of the process developed in the lab and scaled up to the bench scale. The report will include detailed information about the synthetic process, the methods of analysis and also the release specifications for intermediates and raw materials. It will also give information about the economics and other aspects of the process, as well as its potential for validation and further scale-up. There will be suggestions about strategies for the DMF filing process and provides further details about potential suppliers of raw materials and intermediates. The report will also include samples stemming from batches scaled up, along with the Certificates of Analysis, as release information.