ISPE

We would like to extend our thanks to our Corporate Partners, for the support they have provided us. This continued encouragement drives us to continue working on our mission of driving the pharmaceutical industry forward. We look forward to continuing to create opportunities where industry members can form meaningful relationships and exchange knowledge on the global level. We would like to thank, CAI, SteelcoBelimed, Körber, MAASI, Optima, Schneider, Siemens, Trane, Unispace, Valegenesis, Capgemini, Cognizant, COPA-DATA, IPS, Kneat, Pharmadule, PQE, and Veqtor. Learn more about our corporate partners and future opportunities here: https://hubs.la/Q0303csg0 #ISPE #CorporatePartners #pharma #pharmaceutialengineering #pharmaceuticalmanufacturing #biotech #engineering

To date, there has been a reluctance for cell therapy manufacturing facilities to move away from Grade B manufacturing suites even with the implementation of closed processing or the use of isolator technology. Read the sponsored article from Arcadis, “Cell Therapy and Closed Process Manufacturing” by Stephen Judd to learn about the potential to effectively operate cell therapy facilities in lower grade cleanroom manufacturing environments. https://hubs.la/Q0301VZd0

Eli Lilly Kinsale Limited has been recognized as the Overall Winner of the 2024 Facility of the Year Awards (FOYA) for its innovative hybrid manufacturing platform. In this article, Powder & Bulk Solids highlights the Eli Lilly Kinsale Limited facility's recent FOYA win. Read the full article here: https://hubs.la/Q0302lPl0 Plus, don’t miss the 2025 ISPE Facilities of the Future Conference where we will be announcing the 2025 FOYA Submission Finalists: https://hubs.la/Q0302sM40

Frank Henrichmann, Co-Chair of the ISPE GAMP® Global Steering Committee and Coauthor of ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition), discusses the updated Guide, which has been updated to address the rapid progression towards digital transformation and covers new topics such as decentralized clinical trials, the evolution of data management into data science using AI solutions, and guidance for the generation of real-world evidence from real-world data. Learn more in this article: https://hubs.la/Q0302dF80

AGENDA NOW LIVE: 2025 ISPE Europe Annual Conference. Get ready to connect with the best and brightest minds in the pharmaceutical and biopharmaceutical industries. Explore the agenda: https://hubs.la/Q02_ZWDC0

Get more this holiday season: ISPE membership + your gift awaits! An ISPE membership connects you with a global network of over 22,000 professionals, invaluable resources, and industry insights that empower you. Join or renew today https://hubs.la/Q030279-0 and select one of the following exclusive gifts: - Women in Pharma® Tote Bag use code: GIFT24WIP - ISPE Journal and Pen use code: GIFT24Journal - $25 Amazon Gift Card use code: GIFT24Amazon

Congratulations to the ISPE Baseline® Guide: Pharma 4.0™ Team on receiving the prestigious Committee of the Year Award, as part of the 2024 ISPE International Honor Awards. This honor is bestowed upon the authoring team for their contributions to advancing ISPE’s mission. Led by Christian Wöelbeling and Thomas Zimmer, this exceptional team was recognized for their innovative work in developing the ISPE Baseline® Guide: Pharma 4.0™, a comprehensive document designed to lead the industry into the digital age with actionable strategies and best practices. Read iSpeak article: https://hubs.la/Q0301D7j0

Are you ready to share innovative strategies, breakthrough concepts, or proven best practices with your industry peers? Submit your proposal for the 2025 ISPE Biotechnology Conference in Boston, Massachusetts, USA, on 2–3 June. Don’t wait—the submission deadline is approaching fast! Submit now: https://hubs.la/Q02_WldV0 Requested Content areas: - Accelerating Biopharma with AI and ML: From Discovery to Delivery - Process Intensification, Continuous Manufacturing, Sustainability - Operational Readiness and Cultural Excellence - Biomanufacturing Facility Lifecycle: Progress, Trends, and Challenges - Analytical Enhanced Quality - Biotechnology Innovations - Implementing Digital Initiatives in the Biopharmaceutical Industry - Where Are We on the Road Map?

Pharmaceutical facilities play a crucial role in advancing life-saving therapies, but as the industry evolves, sustainability must become a key focus. At the 2025 ISPE Facilities of the Future Conference, we'll explore how the pharmaceutical industry embraces and integrates sustainable practices in facility design and operations to minimize environmental and social impact. Explore track sessions: https://hubs.la/Q02_WlBY0 - Managing Emerging Risks from PFAS Legislations – Takeda Pharmaceuticals Inc. - Solutions to Curb Manufacturing Emissions – Arcadis; Novartis Gene Therapies - Plastic Waste Quantitation in Biopharmaceutical Manufacturing – Thermo Fisher Scientific - Practically Applicable Measures to Save Energy in Cleanroom – Jacobs Italia SpA; Novo Nordisk A/S - Reducing the Carbon Footprint of Cleanroom Environments – G-CON Manufacturing, Inc. - Solvent and Reagent In-Situ Reuse in Solid Phase Oligonucleotide Synthesis - Eli Lilly and Company

Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot be filtered and are manufactured by Aseptic processing. The increase in demand for these life-changing products has been fraught with technical and regulatory challenges as laboratory processes are scaled to commercial manufacturing. As an industry, we need to address ATMP resiliency in its many forms. Read more in this article by Nidhi Shah and Erich Bozenhardt, PE: https://hubs.ly/Q02_BJqV0