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3rd mRNA & CGT: CMC, Process Development and Manufacturing

  • 3rd – 4th December 2026
  • Germany flag Germany Munich

The 3rd mRNA & CGT: CMC, Process Development and Manufacturing Summit, taking place on December 3–4, 2026 in Munich, Germany, will bring together leading experts to examine the newest advancements and unresolved challenges in the development and GMP manufacturing of mRNA-based therapeutics and cell & gene therapies.

As these modalities advance rapidly from early research into late-stage and commercial programs, the demand for robust CMC frameworks, scalable and automated processes, strengthened quality systems, and clear regulatory alignment continues to intensify.The #EmRNA summit provides an essential forum for data-driven discussions, cross-functional collaboration, and problem-solving.

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About the 3rd mRNA & CGT: CMC, Process Development and Manufacturing I #EmRNA

The 3rd mRNA & CGT: CMC, Process Development and Manufacturing Summit is the leading European platform dedicated to advancing the development, scale-up, and GMP manufacturing of mRNA-based therapeutics and cell & gene therapies.
Uniting specialists from biotech, pharma, CDMOs, regulatory bodies, and academia, the summit provides a high-level forum to dissect the technical, regulatory, and operational bottlenecks that define the future of advanced biologics.

Key Themes & Trends

As mRNA and CGT pipelines accelerate toward clinical and commercial readiness, the summit highlights the most pressing innovations in CMC strategy, process intensification, and manufacturability. Delegates will explore forward-looking topics such as:

  • Modular, closed, and automated manufacturing platforms enabling scale-out and contamination control
  • Next-generation LNP formulation and delivery systems for improved stability and biodistribution
  • Advanced pDNA and IVT process engineering, reducing impurities and boosting productivity
  • Digitization, real-time monitoring, and PAT deployment to improve process understanding, robustness, and release readiness

Current Challenges & Practical Solutions

The program focuses on industry-critical pain points and real-world approaches for accelerating development while maintaining regulatory compliance. Expert sessions will address how to:

  • Maintain product quality, purity, and critical quality attributes (CQAs) through scale-up and scale-out
  • Build and validate fit-for-purpose analytical methods for potency, identity, residuals, capping efficiency, and stability
  • Meet evolving global regulatory expectations, including CMC dossier maturity, control strategies, and QbD implementation
  • Manage comparability, process changes, lifecycle control, and tech transfer across sites and modalities
  • Mitigate raw material variability, supply chain risk, and reliance on single-source suppliers

 

Networking & Collaboration

Beyond the technical content, #EmRNA provides a focused environment for cross-functional collaboration among process developers, analytical scientists, regulatory leaders, QA/QC experts, and manufacturing teams. Attendees gain a unique opportunity to benchmark their approaches, exchange best practices, and build partnerships essential to advancing mRNA and CGT products from early development to commercial launch.

Whether you work in CMC, process development, regulatory affairs, manufacturing science & technology (MSAT), or quality, the #EmRNA Summit delivers the insights, data, and strategic direction needed to stay ahead in this rapidly evolving therapeutic landscape.

 

Who should attend:

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

  • CMC (Chemistry, Manufacturing, and Controls)
  • Process Development & Scale-Up
  • Analytical Science & Product Characterisation
  • mRNA and RNA Therapeutics
  • Plasmid DNA (pDNA), In-Vitro Transcription & RNA Technologies
  • Formulation & Lipid Nanoparticles (LNP)
  • Drug Substance and Drug Product Development
  • Bioprocessing, Purification & Production Engineering
  • Manufacturing Science & Technology (MSAT)
  • Quality Assurance (QA), Quality Control (QC) & Quality by Design (QbD)
  • Good Manufacturing Practices (GMP)
  • Process Analytical Technology (PAT)
  • Regulatory Affairs & Compliance
  • Research & Development (R&D)
  • Clinical Development & Safety
  • Commercialisation & Supply Chain Management
  • Oncology, Vaccines & Cancer Immunotherapy
  • Innovation Chemistry & Impurities
  • Comparability & Lifecycle Management

Register by 31st March 2026! 

The Early Bird Offer expires in 82 days!

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

CMC, Process Development & Manufacturing Strategy

  • Build future-proof CMC strategies tailored to mRNA and CGT modalities, incorporating regulatory expectations, platform lifecycle management, and accelerated development pathways.
  • Implement intensified upstream and downstream processes to increase yield, purity, and scalability for mRNA, LNPs, and viral vectors.

Manufacturing Platforms, Automation & Tech Transfer

  • Deploy closed, modular, and digitalized manufacturing platforms to improve flexibility, contamination control, and global tech transfer readiness.
  • Optimize raw material strategies—including nucleotides, enzymes, lipids, and plasmids—to mitigate supply chain risk, variability, and qualification challenges.

Quality, Analytics & Regulatory Expectations

  • Advance and validate analytical methods for potency, identity, purity, and stability of mRNA, LNP formulations, and gene-modified products.
  • Address global regulatory updates for CMC dossier requirements, comparability expectations, platform-based submissions, and evolving RNA-specific guidance.

Formulation, LNP Technologies & Next-Gen Constructs

  • Design and scale LNP formulations with improved reproducibility, encapsulation efficiency, release profiles, and in vivo performance.
  • Explore next-generation mRNA constructs, self-amplifying systems, circular RNA, and emerging delivery technologies to enhance expression, stability, and therapeutic effect.

Digitalization, PAT & Real-Time Process Control

  • Integrate digital tools, automation, AI-driven analytics, and PAT (Process Analytical Technology) to enable real-time monitoring, control, and decision-making during GMP manufacturing.
  • Ensure process comparability across batches, sites, and scale changes using risk-based strategies, robust control frameworks, and strong data governance.
  • Ensure comparability across batches and process changes, including best practices for bridging data and risk-based approaches
  • Explore next-generation mRNA constructs and delivery technologies poised to improve expression, stability, and therapeutic impact

Register by 31st March 2026! 

The Early Bird Offer expires in 82 days!

Dr. Roland Pach, CH

Global Expert, Cell and Gene Therapy Analytics

Roche

Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.

Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.

Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.

In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).

Dr. Miloud G. Nichane, FR

Process Validation Head

LFB

Miloud G. NICHANE currently serves as GMP Auditor and Head of Process Validation at LFB. He holds a PhD in Molecular and Cellular Biology, with a doctoral thesis focused on brain development and architect genes. Over the years, Miloud has built a dynamic career across the pharmaceutical landscape, contributing to both global leaders such as GlaxoSmithKline and the Bill & Melinda Gates Foundation, as well as innovative biotech pioneers like Legend Biotech.

Driven by a strong commitment to advancing the Belgian and broader European life sciences ecosystem, Miloud has worked on a diverse range of therapeutic modalities—including plasmids, mRNA, monoclonal antibodies, blood-derived proteins, and CAR-T T lymphocytes. His multidisciplinary experience offers a unique perspective on the vast potential of modern biomedicine.

Dr. Steven Wolk, US

Founder & Chief Consultant

Sinawali Biotechnology Solutions

Steve is the Founder and Chief Consultant for Sinawali Biotechnology Solutions. He was formerly the Vice President of Chemistry & Boulder Site Head for Editas Medicine, where he led the Advanced Technology, Analytical Sciences & Structural Biology, and Process Chemistry teams. He received his bachelor’s degree in Chemistry from UC San Diego, where he received the Harold Urey Award. He completed his Ph.D. work in Biophysical Chemistry at UC Berkeley under Dr. Ignacio Tinoco, where he used 2D-NMR and other spectroscopic techniques to characterize nonstandard DNA structures. In addition to an extensive history directing analytical groups for characterizing oligonucleotides, proteins, small molecules & polymers, he has led efforts to develop new technologies for delivery of CRISPR therapeutics, and has broad experience in leadership, including management, developing future leaders, creating/revising governance programs, and as a site head.

Dr. Bojan Kopilovic, UK

Postdoctoral Research Associate

The University of Sheffield

Dr. Ilaria Pettinati, NL

Head of Process Development mRNA

Lonza

Ilaria Pettinati is a head of process development mRNA at Lonza Geleen. Before joining Lonza, she worked at eTheRNA Immunotherapies NV where she led the mRNA chemistry team. Previously she was at Oxford Biomedica focussing on process development in the field of lentiviral vectors and other biomolecules, including nucleic acids. Ilaria has a master’s in cellular and molecular biology and a PhD in biophysics in the field of drug discovery, obtained in collaboration with the University of Oxford, where she elucidated structural and mechanistic basis of RNA processing enzymes.

Dr. Roland Pach, CH

Global Expert, Cell and Gene Therapy Analytics

Roche

Dr. Miloud G. Nichane, FR

Process Validation Head

LFB

Dr. Steven Wolk, US

Founder & Chief Consultant

Sinawali Biotechnology Solutions

Dr. Bojan Kopilovic, UK

Postdoctoral Research Associate

The University of Sheffield

Dr. Ilaria Pettinati, NL

Head of Process Development mRNA

Lonza

BROCHURE

Request the 3rd mRNA & CGT: CMC, Process Development and Manufacturing brochure and find out the latest topics and ideas that will be shared.

Request

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Please note that some of our emails may be marked as spam due to your company’s security settings. To ensure we stay in touch, you can also connect directly with Emma at [email protected]

What our
participants
are saying

The #EmRNA Summit offers one of the most practical CMC-focused discussions in the advanced therapy space. The case studies on process development and analytical strategy were directly applicable to our current projects.

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Anna

Director of CMC Development

A highly valuable meeting for anyone involved in mRNA or CGT manufacturing. The depth of technical detail exceeded my expectations.

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Thomas

Head of MSAT

What sets this summit apart is the quality of speakers and the focused networking. I left with actionable insights on scaling mRNA processes and new contacts that will help accelerate our tech transfer efforts.

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Elena

Senior Process Development Scientist