Both in-person and online attendees can participate in numerous networking sessions, panel discussions, and Q&A sessions with industry experts. An event app will also be available, allowing delegates to arrange meetings and calls with other attendees, whether they are joining virtually or in person.
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9th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)
9th HPAPI Milan, September 2026 | #Ehpapi – leading summit for occupational toxicology, containment strategies, advanced facility design, regulatory compliance & HPAPI manufacturing.
calendar_month
Date16th – 17th Sep 2026map
PlaceMilan, ItalyPrice
from€1 399€1 799
calendar_month
Date16th – 17th Sep 2026map
PlaceMilan, ItalyAdvancing HPAPI Innovation Through Expertise, Collaboration and Strategic Networking
The 9th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs), taking place on September 16–17, 2026 in Milan, arrives at a time when the High Potency API (HPAPI) landscape is evolving faster than ever. Driven by precision medicine, oncology pipelines, antibody-drug conjugates (ADCs), and targeted therapies, the demand for highly potent compounds continues to accelerate - reshaping how pharmaceutical companies develop, manufacture, contain, and scale highly active molecules.
At the same time, occupational toxicology, containment strategies, advanced facility design, and digital manufacturing technologies are becoming central pillars of modern HPAPI operations - creating both new challenges and new opportunities for industry leaders, solution providers, and partners. The summit is designed to bring together development, manufacturing, safety, quality, and engineering experts to explore practical solutions, emerging technologies, and collaborative approaches shaping the next generation of HPAPI production.
Beyond the technical program, the 9th HPAPI Summit offers valuable networking opportunities designed to foster meaningful connections and business collaboration. Dedicated networking sessions, interactive discussions, and the business dinner create a relaxed and engaging environment where participants can exchange experiences, explore partnerships, and continue conversations beyond presentations. These informal interactions often become the starting point for new collaborations, technology partnerships, and future projects, making networking an essential part of the summit experience.
For partners and sponsors, the summit provides a targeted platform to connect directly with decision-makers, showcase innovative technologies, and position solutions in front of professionals actively working on HPAPI development, containment, and manufacturing challenges. Through customizable partnership opportunities, sponsors can enhance visibility, engage in technical discussions, and build meaningful relationships with industry leaders.
Why HPAPI Matters More Than Ever
The HPAPI pipeline continues to expand, driven by growth in oncology, targeted therapies, and complex modalities, including antibody-drug conjugates and highly potent small molecules. As a result, pharmaceutical companies and CDMOs are investing in advanced containment strategies, specialized facilities, and new operational approaches to safely manage increasingly potent compounds.
This evolution is creating new expectations across the entire lifecycle:
- Growing number of highly potent molecules in development
- Increasing reliance on outsourcing and CDMO partnerships
- Higher demands for occupational safety and containment
- Complex technology transfer and scale-up
- Increased focus on automation and digitalization
These developments are redefining HPAPI development and manufacturing strategies, while creating opportunities for collaboration, innovation, and strategic partnerships.
What’s Changing in the HPAPI Landscape
Occupational Toxicology Becoming Central to Decision-Making
As potency levels increase and exposure limits become stricter, occupational toxicology is playing a larger role in shaping facility design, containment strategy, and operational planning. Companies are focusing on risk-based exposure control, early hazard assessment, and cross-functional collaboration to ensure safe and efficient production environments.
Advances in Containment & Facility Design
New containment approaches are transforming HPAPI manufacturing:
- Advanced isolators and barrier technologies
- Closed material handling systems
- Flexible, multi-product high-containment facilities
- Modular and scalable facility concepts
These developments enable greater flexibility, improved safety, and more efficient manufacturing for highly potent compounds.
Automation, Digitalization & Smart Manufacturing
The integration of automation and digital technologies is becoming increasingly important for HPAPI production:
- Automated material handling
- Robotics and remote operations
- Digital monitoring and data-driven manufacturing
- Predictive maintenance and performance optimization
These technologies help reduce manual intervention, minimize exposure risk, and improve overall process reliability.
Growing Role of Outsourcing & Strategic Collaboration
As HPAPI manufacturing becomes more specialized, companies are increasingly relying on CDMOs and external partners to support development, scale-up, and commercial manufacturing. This shift is driving demand for strong collaboration models, effective technology transfer, and integrated project management.
What to Expect at the 9th HPAPI Summit
The 2026 edition will explore practical challenges and emerging opportunities across:
Development & Manufacturing
- HPAPI process development
- Scale-up and technology transfer
- Handling ultra-potent compounds
- CMC strategies
Occupational Safety & Containment
- Exposure risk assessment
- Containment technologies
- Cleaning and decontamination
- Worker safety strategies
Quality & Regulatory Expectations
- GMP for highly potent compounds
- Risk-based contamination control
- Global regulatory alignment
- Inspection readiness
Future Technologies
- Automation and robotics
- Smart manufacturing
- Digital monitoring solutions
- Innovative facility concepts
Partnership & Sponsorship Opportunities
The 9th HPAPI Summit provides partners and sponsors with opportunities to:
- Showcase innovative technologies and services
- Engage directly with decision-makers
- Position solutions within real industry challenges
- Build long-term partnerships
Flexible and customizable sponsorship packages allow partners to tailor their presence - from technical presentations and panel participation to branding and networking engagement.
Join the 9th HPAPI Summit
The 9th HPAPI Summit is designed as a collaborative platform for professionals working in highly potent API development and manufacturing. Through technical presentations, expert panels, and dedicated networking opportunities, participants can gain practical insights, exchange experiences, and explore new collaborations.
9th HPAPI: Development and Manufacturing of Highly Potent APIsSeptember 16–17, 2026 Milan, Italy
Join as a participant, speaker, partner, or sponsor - and be part of shaping the future of HPAPI development and manufacturing.
Speakers
Dr. Ulrich Rümenapp, DESenior Biotech Program Lead
James L. Drinkwater, DEHead of GMP Compliance & Honorary member PHSSFranz Ziel GmbH
Christa Myers, USSr. Fellow - Aseptic and Sterile ProductsCRB
Dr. Yuan-An (Angus) Liu , DEDirector Protein & ADC Drug ProductBioNTech SE
Dr. Andreas Schreiner, CHGlobal Validation Network Leader, Validation LeadNovartis
Key points
Risk & Hazard Analysis – Learn how to identify HPAPI hazards, toxicity, and exposure risks to build strong containment strategies.
Containment Advances – Explore the latest isolator designs, engineering controls, and tech solutions that protect workers and ensure product integrity.
PPE Mastery – Best practices for selecting, training, and using PPE tailored for high-potency environments.
OEL Compliance – Setting, maintaining, and monitoring strict occupational exposure limits to safeguard teams and meet regulations.
Facility Design & Optimization – Insights on layout, airflow, and modular upgrades to enhance safety and efficiency in HPAPI production.
Cleaning & Decontamination – Validated cleaning protocols and decon methods to eliminate HPAPI residues.
Training & Safety Culture – Building a proactive culture with targeted training on handling, risk reduction, and incident management.
Waste & Environmental Management – Effective disposal and containment practices to minimize environmental footprint.
Supply Chain Security – Ensuring compliant storage and transport of HPAPIs across the global supply chain.
Global Regulatory Alignment – Staying ahead of FDA, EMA, and worldwide requirements for HPAPI handling and compliance.
Who should attend
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:
- Manufacturing & Processing
- Quality & Compliance
- Health & Safety
- Research & Development
- Business Strategy & Commercialization
- Industry Sectors
- Facility & Equipment Management
- Operational & Plant Management
- Product & Process Quality
- Additional Key Areas
9th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)
9th HPAPI Milan, September 2026 | #Ehpapi – leading summit for occupational toxicology, containment strategies, advanced facility design, regulatory compliance & HPAPI manufacturing.
calendar_month
Date16th – 17th Sep 2026map
PlaceMilan, ItalyPrice
from€1 399€1 799
Industry about us
ChristaInvested Business Leader: Global Aseptic & Sterile Products Vertical Market Leader at CRB
It was a great conference with deep content and even deeper conversations. I love seeing an industry coming together to deep think solutions and plan for the future.
FAQ
Your questions answered here.
Are there networking opportunities?
What delegate (attendee) packages do you offer?
We offer tailored packages based on participant profiles, including options for pharma and biotech companies, solution providers, startups, and academic institutions.
For added flexibility, we also provide virtual attendance and documentation-only packages for selected events.
You can find full details, pricing, and what's included on each event’s dedicated page.
A 10% discount is available for group registrations — contact us for more information.
What’s included in the registration fee?
Registration includes access to all sessions for 2 conference days, official event materials, scheduled networking activities, and catering during the event (coffee breaks and lunches both days) and networking dinner on the 1st conference day to polish your new connections.
Accommodation and travel costs are not included.
Will I receive presentation slides after the event?
Yes — all registered participants receive access to post-event materials, including authorized speaker presentations (subject to permission), and other relevant documents.
If you’re unable to attend in person, a documentation package can be purchased separately. For selected hybrid events, we also offer a recording package with on-demand access to sessions.
What language will the summit be conducted in?
All summit sessions will be presented in English. While translation services are not provided, we welcome attendees from around the world and encourage everyone to join the discussions and networking opportunities.
How can I register for an event?
You can register online via each event’s dedicated page. Once submitted, you’ll receive a confirmation and invoice by email. For special requests, feel free to contact our team directly to hello@etapahub.com or the contact person noted at the designated event page.
How can I get more information?
We’d love to help you make the most of the summit! You can request the summit brochure or contact our team directly using the details below. Our team is happy to answer any questions and guide you in planning your participation.
For any event assistance please contact
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