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Sterility, Manufacturing, and Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

Published Date: December 20, 2021

The biopharmaceutical sector has been changing very rapidly from monoclonal antibodies to cell and gene therapy and RNA-based therapeutics. The growing healthcare needs demand cost-effective and rapid manufacturing technologies. The approval of biosimilars and continuous manufacturing has joined hands with manufacturers to meet these demands. This shift from fixed stainless steel to single-use systems (SUS) has revolutionized the therapeutic market. The rapid market growth for single-use systems, composed primarily of plastic components that are sealed and sterilized using gamma irradiation, is expected to continue. This webinar focuses on product development, including sterilization and lab-testing strategies, to help ensure that there is no contamination in the development and manufacturing of single-use systems, ultimately to promote end-user safety.

Karen Pieters

Karen Pieters

Large Volume Parenterals, Ophthalmics, and Disposables
Senior E&L Expert

Karen Pieters graduated as a bioengineer in chemistry in 2006. Karen joined Nelson Labs Europe in 2010 as a Study Director for different applications. She now leads a team of study directors with a focus on Large Volume Parenterals, Ophthalmics, and Disposables. She has presented on the set-up and challenges of extractables and leachables studies...


Bart Croonenborghs

Technical Director Irradiation, PhD

Bart currently serves as Technical Director Irradiation. During his 14-year career with Sterigenics, Bart has performed IQ/OQ validation of Gamma and Electron beam irradiators, and designed and executed process definition programs (establishing sterilization and maximum acceptable dose) as well as PQ for customers—specifically those in the biologics and pharmaceutical industries. By invitation, Bart speaks at Nelson Labs (a Sotera Health company) training sessions, Sterigenics training sessions, customer training sessions, and industry events such as ICARST 2017, ACP 2017 and, most recently, the CPhI 2018 conference. He is actively involved in industry committees, task forces, and working groups. As a working group member, Bart represents Belgium on ISO TC 198 WG 2 Radiation Sterilization. He is also a member of ASTM E61 and a member and past secretary of the Irradiation Panel.


Jasbir Arora

Director of Bioanalytical, Regulatory, and Quality at the Jefferson Institute for Bioprocessing

Jasbir received his BS, MS, and PhD in Chemistry from Guru Nanak Dev University, India. Along with setting up an analytical laboratory for characterization, QC testing, and release assays for biopharmaceuticals (including cell and gene therapy), Jasbir teaches and trains both students and scientists from the biopharmaceutical industry.

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