The industry embraced single-use (SU) 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 SU 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 SU 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.
Fabian Studer is the Team Leader for Antibody Drug Conjugate (ADC) Production at Lonza Visp and has been in this role since 2013. Fabian brings more than 20 years of experience in the pharmaceutical and biotech industry, including several years of experience in single use technology. Since 1997, he has worked for Lonza in different production units, such as microbial fermentation including USP and DSP, Tides and API production. He was part of the team who introduced the single use equipment for the ADC production. Fabian holds a Degree in Biotechnology and Graduate from the zhaw Wädenswil, Switzerland.