Tech transfer programs are needed in almost all development programs of drug substances, and, although common, almost always represent a critical step. During API development, Fermion offers services which allow customers to reduce the number of tech transfers to only one.

Once a product is transferred to Fermion, we will then apply internal SOP´s for the transfer of the manufacturing technology and/or methods of analysis (validated or non-validated). Our customers can rely on a blue print that Fermion has developed for getting 8 new medicinal entities succesfully approved worldwide. As each API is different from the other, customers’ special requirements for their specific drug will also be included in Fermion’s development program. 

Fermion reviews and evaluates the analytical methods to determine how they can be applied (or adapted) to the set of available instrumentation. If special analytical equipment is needed, which Fermion does not have available, we will also check with the academia for co-operation opportunities (while retaining confidentiality)

Fermion defines the deliverables of “Product Concept 1” as a report on the tests and limits of the process submitted as well as its applicability for larger scale manufacturing. Where appropriate, we will add suggestions for work to be carried out when scaling up the process to the bench scale. The report will include full analytical details, HPLC’s, NMR spectra (13C, 1H and others, if required) as well as any other analytical data agreed upon. Together with this report, samples of the API and/or intermediates made on lab scale (5 – 10 grams each) will also be submitted.