Single-use equipment for handling and manufacturing of highly potent APIs
September 23-26, 2018
The industry embraced single-use technology early on after first off the shelf solutions were brought to the market. Initially focused on cell cultures and cell culture products, the use of single-use production solutions expanded over the last decade into other selected technology areas.
The bioconjugates custom manufacturing offering of Lonza has about a 10 years history. While glass and stainless steel based manufacturing equipment dominated in the beginning, the face of bioconjugates manufacture changed in the meantime quite dramatically. Only 7 years after launch of the new market offering, we achieved first successful end-to-end production out of single-use equipment.
Handling of bioconjugates and especially the toxin payload poses a major challenge. The concept of product (patient) safety, a focus in biopharmaceuticals production, is to be amended by the containment and safe working environment aspect. Advantages, caveats and remaining challenges will be discussed.
Diego Schmidhalter, "Single-use equipment for handling and manufacturing of highly potent APIs" in "Single-Use Technologies III: Scientific and Technological Advancements", Weibing Ding, Amgen Martina Micheletti, University College London Robert Repetto, Pfizer Eds, ECI Symposium Series, (2018). https://dc.engconfintl.org/sut_iii/39