ISPE

This is your chance to make a lasting impact. By donating to the ISPE Foundation’s Greatest Needs program, you’re not just giving—you’re helping to build a stronger, more equitable future for the pharmaceutical industry. As a thank you, every donation of $5 or more to the ISPE Foundation’s Greatest Needs program enters you into a random drawing for a chance to win a $100 Amazon gift card.* - $5 donation = 1 entry - $20 donation = 5 entries - $45 donation (celebrating ISPE’s 45th anniversary) = 15 entries Your contribution, no matter the amount, drives meaningful change. Together, we can empower the next generation of leaders and continue advancing our industry. Make a gift today: https://hubs.la/Q03hq4K-0 *Restrictions apply. Donate at least $5 to the ISPE Foundation’s Greatest Needs program between 10 March and 9 May to enter the raffle (maximum 15 entries per person). The winner will be randomly selected and notified via the email address on file.

Extend your learning with one of two exclusive facility tours after the 2025 ISPE Europe Annual Conference! Autolus: Since its inception, the company has undergone rapid growth, systematically adding the capabilities and capital required to manufacture, develop, and commercialise its programmed T cell product candidates. The Francis Crick Institute: At the Crick researchers investigate the microscopic inner workings of the human body. Through groundbreaking laboratory research, the institute aims to advance the diagnosis, prevention, and treatment of diseases, shaping the future of healthcare. Learn more and register: https://hubs.la/Q03hD_zT0

We are introducing each 2025 FOYA Submission Finalists, before the 2025 FOYA Category Winners are announced at the 2025 ISPE Europe Annual Conference in May. To achieve its own "planet care" targets and ensure long-term site investment, Sanofi constructed the Building 99 - Wastewater Treatment and Recovery Plant (WWTRP). This plant minimizes domestic water usage through waste recycling, ensures regulatory-compliant effluent discharge, and provides an environmental buffer that enables sustainable site growth. Learn more about Sanofi and the other 2025 FOYA Submission Finalists -https://hubs.la/Q039ZdnY0 View upcoming FOYA Activities - https://hubs.la/Q039ZgPj0

You still have time to nominate an ISPE member who is making a real impact in advancing the ISPE mission. Nominate them for the 2025 ISPE International Honor Awards and celebrate their dedication. Submissions are open until 31 May. Learn more and submit a nomination: https://hubs.la/Q03cHwxM0 Categories include: - Max Seales Yonker Member of the Year Award - Richard B. Purdy Distinguished Achievement Award - Joseph X. Phillips Professional Achievement Award - Affiliate and Chapter Excellence Award - Committee of the Year Award - Company of the Year Award - Emerging Leader Member of the Year Award (NEW AWARD FOR 2025)

With regulatory agencies heightening their focus on data integrity and traceability, now is the time to optimize your QMS with environmental monitoring insights. Learn how to leverage real-time environmental data to enhance decision-making, streamline compliance with Annex 11 and 21 CFR Part 11, and mitigate risks before they impact production. Read more in this sponsored article: https://hubs.la/Q03hpctQ0

Last call to secure your spot and get a free guide! Register for an In-Person or Virtual All Access Pass for the 2025 ISPE Biotechnology Conference and receive a FREE printed ISPE Guidance Document to enhance your knowledge. Choose from: - ISPE Guide: Advanced Therapy Medicinal Products – Autologous Cell Therapy (Use code: BIO25AUTOLOG) - ISPE Guide: Biopharmaceutical Process Development and Manufacturing (Use code: BIO25BIOPDM) Secure your spot and your free guide today: https://hubs.la/Q03gZlvX0... Guidance documents will be available as the printed version only and will be delivered by 30 April 2025.

What does it take to stay ahead in the volatile and fast world of pharmaceutical manufacturing? How do we ensure to invest smartly into the future? The industry needs to look beyond just acquiring the latest, cutting-edge technology and how good engineering practices drive efficiency, compliance, and long-term sustainability of production sites and projects. Read more in this iSpeak blog by Michael Dr. Atzor, Estapé David, PhD, Cristina Mazó Riera, and Rebecca Roscher: https://hubs.la/Q03gZmZk0

We are introducing each 2025 FOYA Submission Finalists, before the 2025 FOYA Category Winners are announced at the 2025 ISPE Europe Annual Conference in May. To modernize its production capabilities, Oncomed Manufacturing A.S. implemented the Syringe Line 3 Installation and Facility Modernization project. This initiative introduced new syringe technology, revamped the production building, and established centralized workstations. The project aimed to achieve a 100 million syringe annual production capacity, increase material and solution preparation efficiency, and enhance safety in handling hazardous materials. Learn more about Oncomed Manufacturing A.S. and the other 2025 FOYA Submission Finalists -https://hubs.la/Q039ZcNK0 View upcoming FOYA Activities - https://hubs.la/Q039Zbmb0

We are introducing each 2025 FOYA Submission Finalists, before the 2025 FOYA Category Winners are announced at the 2025 ISPE Europe Annual Conference in May. Johnson & Johnson Innovative Medicine’s mission with the BioCork 3.2 Expansion project in Cork, Ireland was to ensure that they met the needs of their patients today and into the future. To achieve this, they expanded their capabilities with the addition of three large-scale (15,000 litre) production bioreactors, enabling the efficient and sustainable delivery of innovative products. This expansion was designed to fully integrate into their existing live manufacturing plant without disrupting current operations. This investment increased the manufacturing capacity by 80% within budget and ahead of schedule. Learn more about Johnson & Johnson Innovative Medicine and the other 2025 FOYA Submission Finalists -https://hubs.ly/Q039Zbl20 View upcoming FOYA Activities - https://hubs.ly/Q039Z95s0

Your insights matter and time is almost up to complete the brief 2024-2025 ISPE Pharma™ Survey. Submit your responses by 11 April to help us expand our findings: https://hubs.la/Q03ghJHt0 Here's why your input is so important: - It has driven ongoing improvements in the industry and helped establish a shared understanding of regulatory requirements. - Your insights have confirmed the vast potential of digital transformation through Pharma 4.0™. - By sharing your perspective, you contribute to our understanding of how culture and mindset influence the embrace of the 4.0 theme. - Plus, you can join us at the 2025 ISPE Europe Annual Conference in London, UK from 12-14 May and hear the results at the conference and network with industry leaders.