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.
10th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)
10th HPAPI, September 2027 | #Ehpapi – the anniversary summit for next-generation conjugates, occupational toxicology, containment, automation & AI, regulatory compliance & HPAPI manufacturing.
Date22nd – 23rd Sep 2027
PlaceEurope
Price
from€1 299€1 999
Date22nd – 23rd Sep 2027
PlaceEurope
About the 10th HPAPI Summit: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) I #Ehpapi 2027
A Decade of HPAPI: Expertise, Collaboration and Strategic Networking
The 10th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs), taking place on September 22–23, 2027, marks ten editions of a summit that has followed the High Potency API (HPAPI) industry through a decade of rapid change. Today the field is being reshaped by next-generation antibody-drug conjugates (ADCs), radioligand therapies, potent peptides and targeted small molecules – and by the pressure to bring them to patients safely, reliably and at commercial scale. At the same time, automation, robotics and artificial intelligence, a revised EU GMP framework, new trade and supply-chain policies and sustainability requirements are changing how highly potent compounds are developed, manufactured and contained. The anniversary edition brings together development, manufacturing, safety, quality, engineering and supply-chain experts to share practical solutions, look back at what a decade of HPAPI has taught the industry, and look ahead to the next one.
Beyond the technical program, the 10th HPAPI Summit offers valuable networking opportunities – speed networking, interactive panel discussions and the 10th Anniversary business dinner – where participants can exchange experiences, explore partnerships and continue conversations beyond the presentations.
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.
Why HPAPI Matters More Than Ever
The HPAPI pipeline continues to expand, driven by oncology, targeted therapies and complex modalities. Leading CDMOs keep investing in new payload-linker and HPAPI capacity, and companies are rethinking where and how potent molecules are produced. This evolution creates new expectations across the entire lifecycle:
Next-generation ADCs with dual or novel payloads
Radioligand therapies combining radiation and potency hazards
Increasing reliance on outsourcing and integrated CDMO partnerships
Supply-chain resilience, onshoring and regional manufacturing
Higher demands for occupational safety and proven containment
Automation, robotics and AI in GMP environments
What’s Changing in the HPAPI Landscape
Speakers
Dr. Omid ZadakBar, USGlobal EHS Design Engineering, Sr. Mgr.Amgen
James L. Drinkwater, DEHead of GMP Compliance & Honorary member PHSSFranz Ziel GmbH
Christa Myers, USSr. Fellow - Aseptic and Sterile ProductsCRB
Slaviša Oliverović, SLHSE ExpertNovartis
Event Preview
Key points
Next-Generation Conjugates & Payloads – Manage dual-payload ADCs, novel payload classes and degrader-antibody conjugates, from payload-linker synthesis through conjugation to fill & finish.
Radioligands & Dual-Hazard Containment – Combine radiation protection with potent-compound containment in hot cells, isolators and automated synthesis.
HBEL / OEL Setting for New Modalities – Assign OEBs early and derive health-based exposure limits for data-poor and novel compounds.
Containment Verification – Apply SMEPAC, surrogate testing and real-time aerosol monitoring to prove and maintain containment performance.
Automation, Robotics & AI – Reduce operator exposure with robotics and gloveless isolators, and prepare for EU GMP Annex 22 (AI) and the revised Annex 11.
Cleaning Validation & Cross-Contamination – Build HBEL-based cleaning programs and contamination control strategies for multi-product high-containment sites.
Facility Design & Flexibility – Design modular, multi-product and retrofit facilities that scale from clinical to commercial supply.
Sterile HPAPI & Annex 1 – Turn several years of Annex 1 inspection experience into practical solutions for potent sterile products.
Supply Chain Resilience & Outsourcing – Navigate tariffs, onshoring, the EU Critical Medicines Act and CDMO selection for potent molecules.
Sustainability & PFAS – Reduce solvents, energy and waste in high containment and prepare for the EU PFAS restriction affecting fluoropolymer components
Global Regulatory Alignment – Stay ahead of the revised EU GMP chapters and annexes, the EU pharma package, FDA and worldwide requirements.
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
10th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)
10th HPAPI, September 2027 | #Ehpapi – the anniversary summit for next-generation conjugates, occupational toxicology, containment, automation & AI, regulatory compliance & HPAPI manufacturing.
Date22nd – 23rd Sep 2027
PlaceEurope
Price
from€1 299€1 999
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.
Kevin
For what I find really interesting in this conference is there is a mixture of so many experts, we got toxicologists, we got people like Christa, who designs the facilities. We got R&D. We got equipment fabricators. And we are all talking together, sharing experience and learning from each other.
MichaelSenior Director, Technical Operations
The depth of expertise in the room was exceptional. From potent compound handling to cleaning and containment strategies, the discussions addressed the challenges we are actually dealing with in development and manufacturing.
We didn't expect the speed networking, it was unexpected, but I think it was a very positive. In this case we had already some good meeting and we look forward having other interaction with other people.
SophieDirector, CMC & Manufacturing
A very strong mix of regulatory perspective and real-world manufacturing experience. The case studies and open discussions gave us a much clearer view of how others are approaching complex HPAPI challenges.
Sebastian
🎥 Watch the feedback
ClaireHead of Manufacturing Science & Technology
There was a great balance between emerging technologies and proven manufacturing practices. The discussions around containment, occupational exposure and process control gave us several ideas worth exploring within our own programs.
Past events
9th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)
16th – 17th Sep
Milan, Italy
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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