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 SUS, composed primarily of plastic components that are sealed and sterilized using irradiation, is expected to continue.
This webinar will focus on product development, including sterilization and lab testing strategies, to help ensure there is no contamination in the development and manufacturing of SUS to promote end-user safety.
Date: October 26, 2021
Time: 10:00 AM ET / 4 PM CEST (1 Hour with Q&A)
Host: CONTRACT PHARMA
Our guest speaker will be Jasbir S. Arora, PhD, Director Bioanalytical, Regulatory and Quality, Jefferson Institute for Bioprocessing. Joining Jasbir will be our own Expert Advisors: Bart Croonenborghs, PhD, Technical Director Irradiation, Sterigenics and Karen Pieters, Senior E&L Expert, Nelson Labs
Jasbir S. Arora, PhD
Director Bioanalytical, Regulatory and Quality
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 biopharmaceutical industry.
Bart Croonenborghs, PhD
Technical Director Irradiation
Bart joined Sterigenics in 2005 and currently serves as Technical Director Irradiation. During his career with Sterigenics, Bart has performed IQ/OQ validation of Gamma and Electron beam irradiators, and designed and executed process definition programs as well as PQ dose map studies for customers—specifically those in the biologics and pharmaceutical industries. Bart is actively involved in industry committees, task forces, working groups and conference program committees. As a working group member, Bart represents Belgium on ISO TC 198 WG 2 on Radiation Sterilization. He is also a member of ASTM E61 and a member and past secretary of the Irradiation Panel. Education: PhD in Nuclear and Solid State Physics, Leuven University (Belgium).
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 for these applications at several international conferences.
About Jefferson Institute for Bioprocessing: The Jefferson Institute for Bioprocessing (JIB) is the first–and only–specialized education and training institute for biopharmaceutical processing in North America that combines commercial single-use processing equipment with the internationally recognized National Institute for Bioprocessing Research and Training (NIBRT) curriculum. In addition to open enrollment courses JIB offers customized training to meet industry needs including hands-on laboratory and pilot-scale experience. In addition to training, JIB offers global bioprocessing solutions, including consultative services, working with clients on new technology assessments/validation, process development, and bioanalytical services in our 25,000 sq ft. state-of-the-art GLP pilot-scale facility, featuring single-use end-to-end production capabilities. To learn more go to https://bit.ly/3hzNA0p or contact Lyn Kugel at HLynda.Kugel@jefferson.edu.
About Nelson Labs: Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,800 customers across 14 facilities in North America, Asia, and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation through regulatory approval and ongoing product testing for sterility, safety, and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. Learn more about Nelson Labs at www.nelsonlabs.com
About Sterigenics: Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. With our industry recognized scientific and technological expertise we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 48 global facilities that span 13 countries, we offer our customers a complete range of outsourced terminal sterilization services, primarily using the three major sterilization technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation as well as nitrogen dioxide sterilization and x-ray irradiation and expert advisory services. We are committed to addressing the growing need for sterilization in many parts of the world and partnering with our customers to eliminate threats to human health. Learn more about Sterigenics at www.sterigenics.com