Engineering Commons^™

An Approach To Evaluate New Single-Use Film Types, Katharina Blasckczok, Lidija Lisica, Regine Eibl

Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications

During the last decade, single-use bioreactors or storage vessels made of flexible bags have been well-established in biopharmaceutical production. However, some developers and producers of biopharmaceuticals refuse their usage because of potential interactions of the plastic material with cells and proteins. Most dreaded apart from extractables are leachables (such as bDtBPP [1]), that derive from additives and are formed during the bag manufacturing process or gamma sterilization. Leachables can migrate from the film contact layer into the process fluid under process conditions and can inhibit cell growth or impair product quality. A further reason for cell growth limitations can be …