Annex 1 has been in effect since August 2023. But what has been its impact? This topic will be discussed at the 2024 ISPE  Aseptic Conference in Vienna, Austria and virtually. Speakers from both industry and...

ISPE members came together to ask questions about ISPE Communities of Practice (CoPs) in a live session hosted by Tim Postlethwaite, Director of Technical Communities with ISPE, and Anna Riley, Member Operations Manager with ISPE.

In 2020, CSL Behring (CSL) initiated a benchmarking activity with a small group of peer companies identified through ISPE and the members of the ISPE Supply Chain, Operations, and Packaging (SCOPE) Community of Practice (CoP) Steering Committee to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset...

The 2024 ISPE Facilities of the Future Conference will be held on January 29-30, 2024, in San Francisco, CA, USA, and virtually. This conference brings together pharmaceutical industry stakeholders,...

The 2024 ISPE Aseptic Conference will offer a glimpse into the best discussions on the future of aseptic manufacturing. Attendees will learn how optimization is evolving both in the form of digitalization and in...

The 2024 ISPE Facilities of the Future Conference brings more than 130 years of experience and insights from the six keynote speakers alone. GSK’s Carlos Santiago and Genentech’s Christian Randecker provided preliminary insights into what Facility/Factory and Workforce of the Future means to them as well as their greatest successes and challenges as they prepare their teams for that future....

Each year at the ISPE Annual Meeting & Expo, ISPE bestows the ISPE International Honor Awards on a select group of individuals and groups who have gone above and beyond to support ISPE. The Affiliate and Chapter...

The ISPE International Honor Awards program serves as a platform to celebrate the dedication and excellence of our members and their contributions to the pharmaceutical industry. The prestigious 2023 ISPE International Honor Award for Committee of the Year recognizes the remarkable achievements of ISPE's committees, councils, task teams, or communities of practice steering committees.

In the wake of the COVID-19 pandemic, the landscape of cell and gene therapy (CGT) manufacturing has witnessed significant transformation. The industry has seen an increased emphasis on the advantages of advanced therapy medicinal products (ATMPs) and the push for increases in manufacturing scale and overall availability to larger populations. ATMPs find themselves at a critical juncture where...

What is the Route to Successful ATMP Cleanroom Development?

Mitch Gonzales, Vice President of Process Technology and Grant Merrill, Chief Commercial Officer at AES Clean Technology, explore the unique aseptic processing needs of advanced therapy medicinal products (ATMPs) and explain the ideal pathway to successful cleanroom design for this class of therapies.

The ISPE Facility of the Future Conferences can feel like a crystal ball looking into the future . Year after year, speakers have presented what the future of the industry may look like, and then, in subsequent years, speakers will present how they have implemented that future. It is remarkable to see the future come to fruition and learn how others are navigating it. One of the greatest...

At the 2023 ISPE Pharma 4.0™ & Annex 1 Conference in Barcelona, Spain and virtual, Track #6 will focus on

At the 2023 ISPE Annual Meeting & Expo held in Las Vegas, NV, USA on 18 October 2023, a panel of global regulators answered questions submitted by attendees. The panel consisted of Paul Gustafson, PIC/S...

The ISPE 2023 Annual Meeting & Expo agenda is always packed with sessions offering pharmaceutical professionals opportunities to engage in industry-critical conversations. Several of ISPE's regulatory initiatives took center stage during the technical sessions in the Regulatory and Quality track at the

Just around the corner on 11-12 December, join us for a wealth of knowledge sharing, uniting industry experts to engage in discussions that unveil their insights and experiences through the 2023 ISPE Pharma 4.0™ and Annex 1 Conference.

On Wednesday, 18 October 2023, Dr. Celia Lourenco, Associate Assistant Deputy Minister of Health Canada's Health Products and Food branch, presented a keynote address titled “Advanced Manufacturing and Other Trends Supporting Access to Medicines for Patients” at the

In the intricate world of pharmaceuticals, where precision and safety are paramount, the marriage of innovation and sustainability is not just an aspiration—it's a necessity. Picture a scenario where the pursuit of product purity meets the responsibility to our planet. Welcome to the realm of "Eco-friendly Pharma: Sterilization and Sustainable Practices." As we embark on this exploration,...

There are opportunities abound to transform inefficient production processes from the supply chain through the entire manufacturing process using existing and new digital technologies to significantly enhance overall operational efficiencies. Discover the cutting-edge advancements in these essential business areas at the