BioPharm International - September 2024

BioPharm International - September 2024

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www.biopharminternational.com Emerging Therapies eBook September 2024 BioPharm International ® 15 Cell Line Development References 1. SCIEX. Improving the mAb Characterization Process. Whitepaper. Feb. 8, 2024. 2. Zhang, Z.; McCloskey, R. Untangling the Identity of Charge Variants in Antibody-Drug Conjugates. PharmacyTimes. com, Jan. 31, 2024. 3. Adams, G. A Disruptive Approach to Characterization of mAb Charge Variants. Technology Networks. Webinar (ac- cessed May 29, 2024). 4. Scott, M.; Yang, Z.; Zhang, Z.; Nichiporuk, R.; Ostrowski, M. Direct and Rapid Multi-Attribute Monitoring of Multiple Intact Monoclonal Antibodies with a Wide Isoelectric-Point Range of 7.3 to 9.1. Technical App Note (accessed June 3, 2024). 5. SCIEX. Intabio ZT System: Comprehensive Charge Variant Analysis Made Simple. sciex.com (accessed June 3, 2024). 6. Mack, S.; Yang, Z.; Madda, R.; et al. Direct and Rapid Multi-Attribute Monitoring of Intact Monoclonal Antibod- ies by icIEF-UV/MS. Technical App Note (accessed June 3, 2024). 7. McCloskey, R. Advancing Stability in Cell Line Develop- ment. ddw-online.com, April 15, 2024. 8. McCloskey, R. Guide Decisions During Cell Line Develop- ment with More Information at the Intact Level. sciex.com, March 28, 2024. 9. Nields, K. Optimize mAb Development with icIEF-UV/MS. selectscience.net, March 18, 2024. 10. Allerton, J. Improving Drug Development. theanalyticalsci- entist.com, Aug. 21, 2023. 11. Schultz-Kuszak, K.; Cui, M.; Mack, S.; Ostrowski, M.; Razu- nguzwa, T. We All Have Baggage: A Deep Dive into the Characterization of a Complex cIEF Electropherogram from an Antibody-Drug Conjugate Using a Novel Integrated ic- IEF-UV/MS System. Webinar (accessed May 30, 2024). 12. Barker, J.; Mack, S.; Ostrowski, M. A.; Adams, G. A Disrup- tive Approach to Characterization of mAb Charge Variants. Poster Presentation at the American Society for Mass Spec- trometry 2023 Annual Conference, Houston, Texas, June 4–8, 2023. 13. McCloskey, R.; Pohl, K. A Novel Mass Spectrometry Par- adigm to Analyze Classical and New Biotherapeutic. LCGC Supplements 2023, 21 (1), 17–20. DOI: 10.56530/lcgc. na.rk1274v8. 14. Lies, M. LC Europe: Overcoming Complex Analytical Chal- lenges Posed by Targeted Multispecific Antibody Cancer Therapeutics. LCGC International online, July 25, 2023. Q Robert Newman Chief Scientific Officer FUJIFILM Irvine Scientific Staying on Track with Formulation of Cell Culture Media In this episode of the Drug Solutions podcast, Tom Fletcher, director of R&D at FUJIFILM Irvine Scientific, and Robert Newman, PhD, chief scientific officer at FUJIFILM Irvine Scientific, dis- cuss the importance of formulation. Their discussion centers specifically around how culture media should be prepared for bioprocessing use. They also discuss single-use technologies and automation for creating closed systems for cell and gene therapies (CGTs). As part of the Bioproduction division of FUJIFILM Irvine Scientific, which specializes in the development, manufacture, and supply of cell culture media for bioprocessing and CGT applications, Fletcher leads the com- pany's efforts to provide relevant solutions for the various and frequent challenges presented by upstream process development. He has over 30 years of experience serving the biopharmaceutical industry, mostly by developing cell culture media solutions for large-scale production processes. Fletcher has previous experience in protein chemistry research at the University of California, Irvine School of Medicine, and working at Becton Dickinson & Co. Newman, in his role as chief scientific officer at FUJIFILM Irvine Scientific, leads scientific strategy, drives global product development, and expands R&D capability for the company. Newman previously served as senior director for R&D at ATCC and R&D Manager Stem Cells at BD. He holds a PhD in Biochemistry and Molecular Biology from Georgetown University. For more podcast episodes, visit our website! Tom Fletcher Director of R&D FUJIFILM Irvine Scientific About the Drug Solutions Podcast Pharmaceutical Technology® presents the Drug Solutions podcast, where the editors chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the tech- nologies, to strategies, to regulations related to the development and manu- facture of drug products.

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