At this stage, Fermion is now concentrating on manufacturing quantities for launch. Depending on the dosage form, strength and indication of the product, additional scale-up work could be required. Fermion has scaled up processes form lab scale to batch sizes of 2000 kg. Such scale up work requires extensive chemical engineering through process simulation, additional safety studies (especially in case of exothermic reactions) and investigation of ecological impact.

The API work is then crowned with process validation carried out on manufacturing scale.

At Fermion, process optimization continues in a Lifecycle Management environment through agreed-upon milestones with our customers. It includes further process development aiming at reduction of wastes, energy and raw materials which results in an improvement of overall economics.