HAPI and their treatment, OEB-classes
One of Fermion’s greatest strengths is the development and manufacturing of High Potency API’s on a commercial a scale. For evaluating new products, Fermion typically uses OEB value 1 through 5 where available and applicable. Compounds where safety data is unavailable are treated with the highest amount of safety precautions, e.g. contained and automated facilities, operators’ use of space suits during weighing, charging, discharging and dedicated laboratories for analytical processes. In this case, a high potency compound could be either the final API of a new drug candidate, and/or intermediates used for its synthesis.
Fermion processes compounds belonging to OEB classes 1 – 4 and after completion of its plant expansion in early 2012 also OEB class 5 is possible.
Updated
Nov 16th 2011