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Message from the Chair: What’s Next, What Are the New Trends in Aseptic Manufacturing?

Christa B. Myers
2023 ISPE Aseptic Conference

As the 2024 ISPE Aseptic Conference Chair, Christa Myers, Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader at CRB gets asked many times: what’s next? What are the new trends? Can Aseptic manufacturing change be easier, more cost-effective, and manage risks better? What are the inspectors looking for? Why can this not be more clear? Let’s find those answers together.

As we step into a new era of pharmaceutical and biotechnology advancements, there’s no better time or place to explore the cutting edge of aseptic processing than the 2024 ISPE Aseptic Conference in the beautiful city of Vienna, Austria.

In the heart of Europe, Vienna, a city renowned for its rich cultural heritage and historical significance, will serve as the backdrop for this two-day event. The conference’s location couldn’t be more fitting, as Vienna’s tradition of innovation and excellence aligns perfectly with the spirit of progress in aseptic manufacturing.

2024 ISPE Aseptic Conference

Scheduled for 12-13 March 2024, this conference promises to be a gathering of the brightest minds and pioneers in the field of aseptic technology. This event is set to redefine the way we approach sterile processing, drug manufacturing, and patient safety while bringing together a global network of industry professionals, experts, and thought leaders who will share their knowledge, experience, and insights on the latest trends and developments in aseptic processing. Whether you’re a seasoned professional or a newcomer to the field, this conference offers an unparalleled opportunity to learn, network, and collaborate.

The stellar lineup of keynote speakers represents a wide range of experiences in the European market and will bring their own learnings to share with you. These thought leaders and visionaries bring a wealth of knowledge that is nothing more than inspiring. Their varied experiences promise to illuminate the most pressing issues and emerging trends in our industry. Each keynote speaker is a trailblazer who has pushed the boundaries of technology and manufacturing and will undoubtedly ignite curiosity, spark discussions, and set the tone for an intellectually enriching conference. Conference attendees will leave with fresh perspectives, a deeper understanding of what is current and future for our field, and a sense of excitement as we create curative medicines for the world.

There will be many highly technical presentations and discussion groups that will allow for learning and growth in new advances. Robotics is always a hot topic for the Aseptic conference. The advancement of robotics in aseptic filling represents a significant leap forward in manufacturing. As we navigate a world where precision, efficiency, and patient safety are paramount, robotic systems have emerged as game changers. These systems offer an unparalleled opportunity to address manufacturing issues. One of the discussion groups will approach this technology from a different perspective and help answer the questions: what needs to change to allow for robotic filling to be scaled up to faster and larger machines? Will the current regulatory landscape support the divergent thoughts going into changing the ways that fill lines are set up, operated, and cleaned? By streamlining tasks, can we induce a reduction in non-productive downtime? Can we reduce the number of operators needed to operate the overall manufacturing? How close can we get to a “lights out” operation?

Other topics that will be discussed will be Advanced Therapy Medicinal Products (ATMPs), Annex 1 Regulatory compliance issues, and Sustainability. The future state of ATMPs, Annex 1 compliance, and sustainability promised to be transformative. As we look ahead, we anticipate a landscape characterized by heightened automation, personalized medicine, net-zero, and carbon neutral and optimized processes. The advent of cutting-edge technologies will allow for breakthroughs and will demand agile and scalable solutions. The future state is poised to accelerate the development and delivery of more efficient and sustainable solutions for our industry that can have an impact on the world and every patient.

The most anticipated session of the 2023 ISPE Aseptic Conference is always the Regulatory Panel. This year our regulatory panel will be special as it will consist of the regulatory authorities local to Europe and will include the FDA as well. The harmonized approach that is being worked through with PIC/s and the new regulatory requirements associated with the newly released Annex 1 will be discussed with key questions gathered from the industry the weeks before the conference. This is your chance to have your questions answered. You don’t want to miss out as this panel is often the most pivotal session of the conference that is talked about during the lunch and coffee breaks.

The Aseptic conference has helped me build my career with strong technical content and strong relationships. As the 2024 ISPE Aseptic Conference Chair, I invite you to come and build your career with me.

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