Unprecedented Opportunities in ATMP Manufacturing
The ATMP sector is still relatively new compared to traditional biotechnology, and its development and regulatory landscapes are continuously adapting. These therapies represent a significant leap forward in patient treatment, often delivering unique benefits that traditional biotechnology cannot match. Speed and agility are essential for success, and companies are increasingly turning to integrated and automated manufacturing systems to meet these demands. At the heart of this evolution lies a commitment to resiliency—ensuring that processes, facilities, and technologies can withstand the complexities of advanced therapy production.
The ATMP-focused track at 2026 ISPE Aseptic Conference will showcase case studies, technical presentations, and real-world lessons learned, offering attendees practical strategies to overcome challenges and seize opportunities.
ATMPs Sessions at the 2026 ISPE Aseptic Conference
ATMPs-focused sessions will provide a platform for pharmaceutical professionals to share insights, discuss challenges, and explore opportunities from both industry and regulatory perspectives. The ATMPs and ATMPs with Multiproduct tracks include presentations covering key areas such as:
Key Topics in the ATMPs and ATMPs with Multiproduct Tracks
- Materials Transfer: Best practices and risk assessments for contamination control in cleanrooms
- Maximizing Gene Therapy Doses: Leveraging robotics and digitalization to optimize aseptic processes
- Rapid Safety Testing: Alternative methods for faster, reliable quality assurance
- Multi-Product Facility Lessons: Insights into facility design, operational readiness, and team building
- Digital Twin Technology: Harnessing AI/machine learning (ML) and data ecosystems to transform ATMP manufacturing
1. Materials Transfer for ATMP Cleanrooms
Maintaining contamination control during materials transfer into ATMP cleanrooms is essential for patient and operator safety. This session will explore:
- Risk assessment procedures for introducing materials into classified areas
- Best practices for controlling particles, endotoxins, and bioburden
- Case studies on pass-through decontamination for Grade B cleanrooms and biological safety cabinet hoods. Given that material transfer is one of the largest contamination risks, this discussion will provide actionable strategies to mitigate these challenges
2. Maximizing Gene Therapy Doses for Patients
As demand for gene therapies grows, automation and digitalization are critical for optimizing aseptic drug product processes. This presentation will highlight:
- How robotics and digital solutions enhance efficiency, precision, and safety
- Strategies to meet stringent regulatory requirements while reducing contamination risk
- The role of cutting-edge technologies in improving product quality
3. Building an Approach to Rapid Safety Testing of ATMPs
Speed is vital in ATMP manufacturing. In many cases, patients with life-threatening illnesses are waiting for an important therapy to be manufactured. This session will examine rapid alternative safety testing methods (e.g. sterility, bioburden, mycoplasma) and their integration into a comprehensive quality assurance strategy.
4. Multi-Product ATMP Facility: Real-World Lessons
Building a commercial ATMP facility on a patient-driven timeline requires careful planning. This case study will share:
- Core technical lessons: facility flow design, utility infrastructure, cleanroom construction, and maintenance mindset
- Operational insights: team onboarding, infrastructure oversights, and construction management. Attendees will gain practical knowledge on what worked well and what could be improved
5. Optimizing Aseptic ATMP Processes via Digital Twin Technology
Digital twins are transforming ATMP manufacturing. This session will explore:
- How mature digital architectures and streamlined data models enable optimization
- Real-world experiences and lessons learned from implementing digital twins
- Best practices for leveraging AI/ML and data ecosystems to enhance aseptic processes
Why This Matters
The ATMPs and ATMPs with Multiproduct tracks at ISPE Aseptic 2026 are more than a series of presentations—they are a collective, collaborative effort to shape the future of advanced therapies. By sharing knowledge and embracing innovation, the industry can deliver life-changing treatments faster, safer, and more efficiently.
Conclusion: Driving Innovation Through Collaboration
The ATMPs and ATMPs with Multiproduct tracks at the 2026 ISPE Aseptic Conference provide more than a learning opportunity—attending the event can serve as a catalyst for progress. By sharing knowledge, embracing digital transformation, and prioritizing patient safety, the industry can accelerate the delivery of advanced therapies that change lives. Join ISPE to be part of the conversation and help shape the future of aseptic manufacturing for ATMPs.
Learn more and Register
