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PharmTech.com Quality and Regulatory Sourcebook eBook March 2024 Pharmaceutical Technology ® 9 Manufacturing 6. Das, S. The Appeal of Single-use Tech. BioSpectrum India online, Nov. 30, 2022. 7. Parenteral Drug Association. Technical Report Num- ber 66: Application of Single Use Systems in Pharma- ceutical Manufacturing. Technical Report, Septem- ber 2014. 8. ISPE. ISPE Good Practice Guide: Single-Use Technol- ogy (2018). 9. Barbaroux, M.; Horowski, B.; Mokuolu, S.; Petrich, M.; Whitford, W. The Green Imperative: Part One— Life-Cycle Assessment and Sustainability for SUTs in the Biopharmaceutical Industry. BioProcess Int. 2020, 18 (6). 10. Budzinsk i, K.; Constable, D.; D'Aqui la, D. et a l. St rea m li ned L i fe Cycle Assessment of SU Ts i n Biopharmaceutical Manufacture. New Biotechnol. 2022, 68, 28–36. DOI: 10.1016/j.nbt.2022.01.002 11. Scott, C. Cell Culture. BioProcess Int. 2011, 9 (10). 12. Andersen, O.; Hille, J.; Gilpin, G.; Andrae, A. S. G. Life Cycle Assessment of Electronics. In Proceedings of IEEE Conference on Technologies for Sustainability (SusTech), Piscataway, NJ, 2014, pp. 22–29. 13. Donawa, M. Medical Device Clinical Investigations. Whitepaper, 2006. 14. DIN EN ISO 14040:2006. Umweltmanagement—Öko- bilanz—Grundsätze und Rahmenbedingungen (2021). 15. Goedkoop, M.; Oele, M.; Leijting, J.; Ponsioen, T.; Meijer, E. Introduction to LCA with SimaP ro; PRé Sustainability B.V., 2016. 16. ISPE. End-Of-L i fe Ma nagement for Si ng le-Use Products in Bioproduction Part 1. ispe.org, March 14, 2023. 17. ISPE. End-Of-L i fe Ma nagement for Si ng le-Use Products in Bioproduction Part 2. ispe.org, March 24, 2023. 18. USP. USP General Chapter <665>, Plastic Compo- nents and Systems Used to Manufacture Pharma- ceutical Dr ug Products and Biopharmaceutical Drug Substances and Products. USP-NF (Rockville, Md., 2022). 19. BioPhor um. Best P ract ices Guide for Evaluat ing Leachables Risk from Polymeric SUS Used in Biophar- maceutical Manufacturing (June 2018). 20. USP. USP General Chapter <1665> Characterization and Qualification of Plastic Components and Sys- tems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. USP-NF (Rockville, Md., 2023). ■ The Rush for Quality Data and the Means to Protect It In this episode of Drug Digest, industry experts discuss why data is the biopharma industry's most valuable asset today. The discussion also delves into the means by which the industry as a whole is learning to upgrade data integrity practices to better protect their data and the use of innovative technologies, such as advanced graph technolo- gies, to better shape the drug discovery and development process. Drug Digest is a tech talk video series with the Pharmaceutical Technology ® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products. Nathalie Batoux, Product Manager, Research Innovation, IDBS Jeremy Grignard, Data & Research Scientist, Servier For more videos, visit PharmTech.com! Thierry Dorval Head of Data Science & Data Management Servier