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5th Gene & Cell Therapy CMC: Process Development, Quality and Vector Manufacturing
Early bird price

5th Gene & Cell Therapy CMC: Process Development, Quality and Vector Manufacturing

Explore the latest innovations in CMC strategy, process development, regulatory quality, and scalable vector manufacturing for GCT products. #EGeneCell Berlin 2026

calendar_month
Date19th – 20th May 2026
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PlaceBerlin, Germany
Price
from6991 199
calendar_month
Date19th – 20th May 2026
map
PlaceBerlin, Germany

#EGeneCell 2026 brings together the experts shaping the next generation of AAV, LV, non-viral vector, and cell therapy manufacturing, with a focused agenda dedicated to CMC strategy, process development, quality, analytics, and scalable vector production. 

As advanced therapies move rapidly toward late-stage clinical and commercial reality, the summit provides a critical platform to address regulatory expectations, comparability requirements, cost pressures, manufacturing bottlenecks, and evolving analytical standards across the CGT landscape.

Why Attend? 

Experience a deep dive into next-wave technologies, new regulatory guidance, and emerging industry standards that are redefining how gene and cell therapies are designed, manufactured, and controlled.#EGeneCell 2026 highlights innovations in:

  • Closed & modular manufacturing platforms

  • Continuous processing and intensified workflows

  • AI/ML-driven analytics and digital CMC

  • High-productivity vector engineering & novel capsids

  • Advanced CQAs, potency assays, and functional release testing

  • Automation & robotics for aseptic CGT operations

This event is designed to equip teams with actionable solutions to scale complex therapies while safeguarding quality, safety, and regulatory compliance.

Industry Trends, Pain Points & Critical Issues

  • Regulatory Tightening & Evolving Guidance

New expectations for potency assays, comparability, and raw material control are increasing CMC complexity.

  • Manufacturing Scalability & Cost Pressure

Challenges include:

Speakers

Dr. Roland Pach, CH
Dr. Roland Pach, CHGlobal Expert, Cell and Gene Therapy AnalyticsRoche
Volker Huppert, DE
Volker Huppert, DEChief Development OfficerGlycostem Therapeutics
Dr. Carmen Brenner, BE
Dr. Carmen Brenner, BEDirector of Quality ControlNovadip
Dr. Rahul Kaushik, DE
Dr. Rahul Kaushik, DEFounderGene Therapy Consultancy
Dr. Amey Bandekar, US
Dr. Amey Bandekar, USAssociate Director Drug Product DevelopmentSanofi

Key points

  • Advancing CMC Strategy for Next-Gen CGTs: Explore updated guidance and best practices for building robust CMC packages—covering stability, comparability, raw material qualification, and lifecycle management for AAV, LV, and engineered cell therapies.

     

  • Ensuring CGT Safety, Quality & Regulatory Alignment: Learn how to align processes with evolving expectations from EMA, FDA, MHRA, and global agencies. Gain insights into:

    • potency assays

    • impurity profiling

    • adventitious agent testing

    • viral safety

    • chain of identity/chain of custody

     

  • Optimizing & Scaling Vector Production: Understand new strategies for improving productivity, reducing cost of goods, and addressing bottlenecks in:

    • AAV & LV upstream yields

    • empty/full ratio control

    • plasmid supply & IVT scalability

    • purification efficiency

    • process intensification and automation

     

  • Integrating New Technologies: See how digital twins, AI-enabled monitoring, PAT, real-time release, and high-throughput analytics are reshaping CGT manufacturing efficiency and reducing failure risk.

     

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:

  • Gene & Cell Therapy Modalities
  • CMC, Process & Manufacturing
  • Quality, Safety & Regulatory
  • Analytics & Innovation
  • R&D, Clinical & Commercial

5th Gene & Cell Therapy CMC: Process Development, Quality and Vector Manufacturing

Explore the latest innovations in CMC strategy, process development, regulatory quality, and scalable vector manufacturing for GCT products. #EGeneCell Berlin 2026

calendar_month
Date19th – 20th May 2026
map
PlaceBerlin, Germany
Price
from6991 199

Industry about us

Sofia from null
SofiaDirector of Process Development

This summit delivers an unmatched blend of scientific depth and practical CMC insights. The discussions around scalable vector manufacturing were immediately applicable to our ongoing programs.

Michael from null
MichaelVP, CMC & Technical Operations

A must-attend event for anyone working in gene and cell therapy manufacturing. The quality and regulatory sessions helped us refine our global CMC strategy and prepare for upcoming filings.

Elena from null
ElenaHead of Manufacturing Sciences & Technology

Exceptional networking and high-value content. The focus on automation, digital tools, and CQAs provided a clear path for modernizing our CGT production platforms.

FAQ

Your questions answered here.

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.

What networking opportunities are available?

Our events are designed to spark genuine connections. In-person participants benefit from structured formats like speed networking sessions, as well as informal interactions during the exhibition, coffee breaks, lunches, and networking dinners — where all participants are invited.

Virtual and hybrid attendees can also connect through our event platform, which supports chat, meeting requests, and live Q&A with speakers and peers.

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 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.

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.

For any event assistance please contact

Gabriela Rychtářová
Gabriela RychtářováSales & Marketing Manager