BioPharm International - March 2024

BioPharm International - March 2024

Issue link: https://www.e-digitaleditions.com/i/1517675

Contents of this Issue

Navigation

Page 22 of 23

www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2024 BioPharm International ® 23 Manufacturing 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.; Mei- jer, E. Introduction to LCA with SimaPro; PRé Sustain- ability B.V., 2016. 16. ISPE. End-Of-Life Management for Single-Use Prod- ucts in Bioproduction Part 1. ispe.org, March 14, 2023. 17. ISPE. End-Of-Life Management for Single-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 Drug Products and Biopharmaceutical Drug Substances and Products. USP-NF (Rockville, Md., 2022). 19. BioPhorum. Best Practices Guide for Evaluating 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). ■ Ramesh Raju Mavuleti*, rrajum@gmail.com, is head of operations, Validation Services India; Subhasis Banerjee, PhD, is principal technical application expert, Bioprocessing APAC; and Tathagata Ray, is consultant, Global Strategy Deployment; all at Merck Life Sciences Pvt, Ltd.; K. Vasantakumar Pai, PhD , is professor and chairman, PG Department of studies & research in Industrial Chemistry, Kuvempu University; K. Sreedhara Ranganath Pai, PhD, is professor, Department of Pharmacology, Manipal Academy of Higher Education; and Somasundaram Gopalakrishnan, is senior consultant, Global Biopharm Center of Excellence, Merck Pte. Ltd. *To whom all correspondence should be addressed. Zara Bukhari, PhD Student, Biochemistry University of the Pacific Stockton, California John Gabrielson Senior Vice-President, Biosimilars, and Head of Business JSR Life Sciences The Biosimilars Landscape This episode of the Drug Solutions podcast gives an overview of the biosimilars market. Industry experts discuss regulatory controls, pricing pressure, the state of the healthcare industry, and other factors affecting the uptake of biosimilars in the market. Manufacturing challenges as well as current and future needs will also be discussed. 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 technologies, to strategies, to regulations related to the development and manufacture of drug products. For more podcast episodes, visit our website! SCAN ME

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - March 2024 - BioPharm International - March 2024