Biopharmaceuticals are medicinal substances that are produced in genetically modified organisms using biotechnology. They are especially complex molecules and therefore temperature sensitive.Biopharmaceuticals are amongst the key growth drivers in the pharmaceutical and biotechnology industries. Approximately 60% of these products, such as special cancer treatment substances and antibodies, require especially gentle drying with the lyophilisation process to attain adequate shelf life.
In this case a special aspect of the process of preparing medicinal substances in vials, which is customary in the pharmaceutical industry, is the low concentration of active pharmaceutical ingredients (APIs) per individual dose. In many cases only a few milligrams of the material are added to the matrix materials. Small batches of these highly specific active substances require freeze dryers with small to medium dimensions and a typical shelf area of 2 to 4 m². Due to the high value of these products, the requirements for reliability and the technical implementation of the systems are extremely stringent.
Aseptic production over the entire process chain demands fully automatic loading and unloading in isolators as well steam-sterilisable freeze dryer design.
3D animation of a typical fill-finish process for biopharmaceuticals (from left to right) with isolator: