Cell & Gene Therapy Manufacturing 2025

ENHANCING SPEED & QUALITY IN CELL & GENE THERAPY MANUFACTURING FOR THE DACH REGION

12th -

13th

February 2025 |

Messe and Congress Center Basel, Switzerland

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CONCEPT

EVENT CONCEPT

The landscape of cell and gene therapy manufacturing is experiencing a transformative evolution, fueled by advancements in technology and process optimization. This shift holds the promise of revolutionizing the production of therapies aimed at curing previously incurable diseases. Regulatory milestones, such as FDA approvals for novel manufacturing techniques and breakthrough therapies, highlight the significant progress within the field.

The emergence of innovative manufacturing platforms, including bioreactors, in-vivo cell engineering, and 3D cultures, is reshaping the way therapies are produced. These advancements, coupled with the potential of universal donor iPSC and CRISPR-based manufacturing techniques, are driving dynamism and scalability in the manufacturing process. However, alongside these breakthroughs, the manufacturing sector faces strategic challenges throughout the commercialization journey. From navigating regulatory compliance to optimizing production costs and ensuring quality control, addressing these hurdles is imperative to fully harness the transformative potential of cell and gene therapies.

We are thrilled to invite you to the Cell & Gene Therapy Manufacturing Summit 2025, where industry leaders and experts will converge to explore the forefront of CGT development and manufacturing. We will cover topics such as innovations in upstream and downstream processing, precision analytics, and efficient distribution. Expert panels will delve into cutting-edge bioprocessing and cell therapy manufacturing innovations. Your participation will help drive the future of CGT. We look forward to seeing you there!

WHAT TO EXPECT:

200+ Attendees and 100+ Organizations participating in ground-breaking discussions on advanced manufacturing technologies and cost optimization.

30+ Expert Speakers presenting breakthrough innovations in upstream/downstream processing, including bioreactors and 3D cultures.

Precision Analytics and QA/QC strategies to enhance quality and scalability in cell and gene therapy manufacturing.

Dynamic Panels and Interactive Roundtables addressing bioprocessing, AI, scalability, and sustainability.

Exclusive CMO Showcase and Networking Lunches for key stakeholders, with a strong focus on the DACH region.

Transformative CAR-T Therapy Sessions focusing on oncology applications and breakthroughs.

Comprehensive Viral Vector Sessions covering lentivirus, AAV, and adenoviral vectors.

120+ Networking Opportunities with key DACH region stakeholders, including drinks receptions and informal gatherings.

FEATURED CONTENT

CGT DACH Region Distribution Map

Blueprint Of Success: Download CGTWS Previous Event Report

Optimizing Cell & Gene R&D Streamlining Manufacturing and Expanding Access in Europe

Optimizing Cell & Gene R&D, Streamlining Manufacturing, and Expanding Market Access in Europe

CDMO Geographical Distribution Infographic

[Webcast] Advancing Cell & Gene Therapy: Current Landscape and Future Outlook

CGTWA23_Ebook-cover-1500-x-1500-1024x1024

Revolutionizing Healthcare: Cell & Gene Therapy In UK

Cell & Gene Therapy Manufacturing 2025

Commercializing Cell & Gene Therapies in global markets

Navigating global regulatory landscapes for successful CGT commercialization across diverse markets

Developing scalable manufacturing and distribution strategies to meet global demand

Building strategic partnerships to enhance market access and accelerate therapy adoption worldwide

Considerations for the development and commercialization of autologous CAR-T cell products

Balancing personalized production with cost-effective scaling for broader patient access

Ensuring efficient vein-to-vein delivery while maintaining product quality & regulatory compliance

Overcoming challenges related to pricing, reimbursement, for commercial success

Leadership Panel Discussion: How to achieve convergence of viral vector manufacturing technologies towards robust platform processes?

Streamlining viral vector production through standardized platform technologies

Enhancing scalability and efficiency in viral vector manufacturing

Overcoming challenges in process consistency and regulatory compliance

Synthetic biology for forward cell reprogramming

Understanding synthetic gene circuits to precisely control cell fate transitions and reprogram cells into desired types.

Scalable production of reprogrammed cells for regenerative medicine and personalized therapies.

Simplifying the reprogramming process by integrating synthetic biology tools for more efficient, targeted cell conversions.

Optimizing Upstream Processes for Enhanced Cell Quality and Viability in Dendritic Cell-Based Allogeneic AML Immunotherapy

Dendritic cells derived from leukemic progenitors hold promise for novel cancer immunotherapies.

Mendus has developed DCOne, a proprietary platform using a unique cell line to produce off-the-shelf leukemic-derived dendritic cells.

Our lead program, vididencel, delivered positive Phase 2 results as a maintenance therapy for AML.

Industrialization of a novel vector for gene therapy – Arenavirus

Developing efficient processes for large-scale production of Arenavirus vectors

Ensuring adherence to regulatory standards for clinical and commercial applications

Expanding the use of Arenavirus vectors in various gene therapy treatments

Advancements in Viral Vector Design for Repeated Administration in Chronic and Intractable Diseases

Curigin’s innovative approach involves genetically modifying the capsid surface of viral vectors to prevent exposure to antibodies, allowing for repeated administration in patients with existing antibodies.

This breakthrough technology enables effective and continuous treatment administration, crucial for achieving therapeutic outcomes in chronic and intractable diseases.

The CMC Challenges of the Downstream Process Development and Scale Up

Novel engineered Fc-fusion proteins for cell therapy.

The CMC complexities of cell therapy product characterization.

Addressing the hurdles in scaling up cell therapy manufacturing, from batch-to-batch consistency to the application of automated systems.

A Platform Technology for Downstream Reprogramming of Cell Fate

Introducing a platform to identify lineage control switches that enhance downstream cell differentiation processes.

Understanding how these switches optimize cell quality, stability, and functionality during reprogramming.

Exploring applications for improving cell-based products in regenerative and personalized medicine.

Innovative Adsorptive Separation Strategies for Viral Gene Therapy Vectors

Exploring advanced methods to enhance the purity and yield of viral gene therapy vectors in downstream processing.

Optimizing adsorptive separation techniques to improve efficiency and scalability in the isolation of viral vectors.

Discussing the impact of these innovations on the delivery and efficacy of therapeutic genes, advancing treatment outcomes.

Twin-Column Continuous Chromatography for Improving Viral Vector based Gene Therapies

Enhancing purification efficiency for viral vectors in gene therapies through twin-column continuous chromatography.

Reducing production costs and time by streamlining the purification process.

Improving product yield and consistency for large-scale viral vector manufacturing.

Industrialization of cell therapies: Platform Approaches

Standardizing production processes to enhance scalability and reduce costs

Leveraging automation and data analytics to optimize efficiency and maintain quality.

Developing adaptable platforms that support multiple cell therapy types for faster development and commercialization

Streamlined GMP Manufacturing and Innovative Tracking System for TCR-T Cell Therapy

Streamlined TCR-T therapy production with an automated 6-day GMP process.

Optimized 3rd generation TCR-T therapy for treating multiple solid tumor indications

UniTope & TraCR: An innovative and universal tool for tagging and tracking of TCR-T cells

Strategies for Intensification: Achieving Continuous Processing

Strategies for Achieving Continuous Processing Intensification

Methods to Enhance Continuous Processing

Intensification Techniques for Seamless Operations

Programmable and auto-regulated viral vectors for new applications of gene therapy

Viral vectors are evolving to offer more precise gene delivery for treating genetic disorders, with greater control over gene expression.

New advancements allow vectors to be auto-regulated in response to physiological cues, ensuring more targeted gene expression.

These programmable, vector-agnostic systems increase safety and on-target efficacy, expanding potential therapeutic applications.

Navigating CMC and Regulatory Hurdles for CAR T Cell Therapy: Strategies for Post-Approval Changes in Autologous Cell Therapies

Key considerations for maintaining product consistency and safety in CAR T therapies.

Navigating evolving standards and ensuring alignment with regulatory expectations.

Best practices for implementing post-approval changes without compromising quality or efficacy.

Patient-Centric Manufacturing and Safety

Ensuring patient safety throughout the manufacturing and delivery of cell and gene therapies.

Integrating patient safety science into manufacturing practices to enhance product safety.

Addressing challenges and solutions in maintaining patient-centric approaches during production.

Advancing Red Blood Cell Production from Stem Cells: Enhancing Yield and Quality

Developed a high-yield method to produce red blood cells from CD34+ stem cells.

Achieved longer survival and superior functionality of ex vivo generated RBCs compared to standard RBCs.

Potential to reduce transfusions for patients with blood disorders like β-thalassemia and sickle cell disease

Adopting a Risk-Based Approach to CGT Production for Enhanced Quality and Compliance

Implement risk assessment tools to identify and mitigate potential hazards in CGT production.

Optimize manufacturing processes by prioritizing critical control points for product safety and efficacy.

Align production strategies with regulatory requirements, ensuring continuous risk management throughout the product life cycle.

Efficiency and Scalability in CRISPR Manufacturing

Addressing the challenges of scaling up CRISPR-based therapies.

Automation and standardized production processes to meet clinical and commercial demand.

Case Studies on CRISPR manufacturing through efficient gene modification.

Overcoming Bottlenecks in CRISPR Manufacturing for Gene Therapy

Recent innovations and improvements in CRISPR technology and manufacturing processes.

Practical strategies and best practices for optimizing the workflow.

Advancing Regulatory T Cell Therapies: Applications & Innovations in Cell Therapy

Breakthroughs in enhancing the efficacy and specificity of Tregs in cell-based therapies.

Ongoing clinical trials and real-world applications for treating autoimmune and inflammatory diseases.

Exploring new indications and the broader impact of Treg cell therapies in immunotherapy

Advancing Autologous Cell Therapies for Muscle Regeneration

Exploring cutting-edge techniques in developing and optimizing autologous cell-based therapies for muscle diseases..

Addressing common challenges in the development and implementation of autologous cell therapies, including scalability and regulatory considerations.

Manufacturing Stromal Cell Therapeutics for Type 1 Diabetes

Streamlining the production of stromal cell-based therapeutics aimed at treating and potentially curing type 1 diabetes.

Key breakthroughs in the scalable manufacturing of stromal cell therapies for diabetic patients.

Ensuring quality and consistency in stromal cell manufacturing to improve patient outcomes and disease management.

Gene Therapy Manufacturing in the AI era

Current landscape of AI used in gene therapy manufacturing.

Challenges and enablers in adoption.

Standardizing genome-wide off-target prediction methods.

Development of Digitalization and Automation in Viral and Non-Viral Vector Production.

Recent advancements in automation technologies specifically designed for vector production.

Use of robotic platforms and automated assays to rapidly test and refine vector designs.

Strategies to reduce the potential for errors during the formulation process.

Scaling Out vs. Scaling Up: Best Practices for CAR-T Cell Therapy Production

Expanding capacity by replicating smaller production units to meet demand.

Increasing the size and efficiency of existing production processes for higher output.

Balancing cost, efficiency, and quality while scaling CAR-T cell therapy production.

Rapid Analytical Methods for Real-Time CAR-T Product Release

Deploying technologies for immediate assessment of CAR-T product quality.

Rapid assays to ensure potency and purity without delays.

Streamlining quality control with automation for consistent real-time results.

Innovations in Lipid Nanoparticles for Gene Delivery

Latest advancements in lipid nanoparticle formulations.

Improvements in lipid composition, surface modifications for enhanced cellular uptake.

Strategies for targeted delivery to specific tissues or cells in precision therapy.

Clinical Applications and Future Directions of Non-Viral Vectors in Gene Delivery

Examination of recent clinical applications of non-viral gene delivery methods.

Discussion on vector design and techniques.

Future trends and potential innovations that could further advance the field.

CMC Challenges in Gene Therapy Development: Adding Sustainability to a Complex Equation – A Biotech Case Study

Addressing CMC complexities while integrating sustainable practices.

Reducing waste and energy consumption in gene therapy production.

Real-world lessons from a biotech company’s sustainable approach.

Sustainable Practices in Viral Vector Manufacturing

Advances in waste minimization and recycling in vector production.

Low-impact methods for scaling up viral vector manufacturing.

Integration of sustainability metrics in production planning.

To stay informed about event updates, including date, venue, and agenda, please subscribe to our newsletter on our event website. You can also follow our official social media channels for real-time updates and announcements.

Our event is designed to cater to a wide range of professionals within the biopharmaceutical industry, including researchers, scientists, executives, regulatory experts, and professionals involved in drug development and manufacturing.

The conference will provide a comprehensive learning experience covering various aspects of the dynamic biopharmaceutical industry, ensuring attendees gain valuable insights and knowledge.

Participants can expect to gain insights from industry experts, network with peers, and stay up-to-date with the latest trends and innovations in biopharmaceuticals.

To register for the event, please visit our registration page on our website. You’ll find detailed instructions and options for registration, including pricing and deadlines.

We welcome presentation submissions. If you’re interested in speaking at the event, please visit our “Call for Speakers” page on our website for submission guidelines and deadlines.

Yes, we offer sponsorship and exhibition opportunities for businesses and organizations. Please visit our “Sponsorship Opportunities” page on our website for more information.

We are committed to ensuring the safety and well-being of all attendees. We will implement rigorous safety measures in line with local health guidelines and regulations. Specific safety measures will be communicated closer to the event date to ensure they align with the most up-to-date health recommendations. Rest assured, your safety is our priority.

Yes, we have networking sessions, workshops, and social events scheduled throughout the event to facilitate connections and collaborations among attendees.

Yes, we have a cancellation and refund policy in place. Please refer to our “Cancellation Policy” on our website for details on how to request a refund if you are unable to attend.

THANK YOU TO OUR SUPPORTING PARTNERS

2025

SPEAKERS

Featuring esteemed voices from the biopharmaceutical sector. Our selected experts will share insights on the latest trends, challenges, and developments in this dynamic field. Engage in unique discussions, learn about cutting-edge scientific discoveries, and explore the future of biopharmaceuticals with these influential thought leaders. Don't miss this chance to broaden your understanding of this ever-evolving industry.

Abi Abitorabi

VP Cell & Gene Platform Implementation

Bayer

Germany

Alberto del Río Espínola

Director in Toxicology

GentiBio

Switzerland

Alois Jungbauer

Professor, Institute of Bioprocess Science and Engineering, Department of Biotechnology

University of Natural Resources and Life Science

Austria

Arindam Mitra

Director CMC

Leucid Bio

United Kingdom

Carl DeLuca

VP Technical Development & Global CMC Project Mgmt

Orchard Therapeutics

Switzerland

Dirk Boehm

Head Cell and Gene Therapy CMC & Industrialization

Bayer

Switzerland

Farzin Farzaneh

CSO & Chair of Molecular Medicine

King’s College London, ViroCell

United Kingdom

Jae-Gyun Jeong

President

Curigin

Seoul

Joshi Venugopal

Senior VP - Head of Europe, Novartis Gene Therapies & Rare Diseases

Novartis

Switzerland

Kostadinka Lilova

VP Process Research

Autolus Ltd

United Kingdom

KwangJun Yoon

Managing Director

CHA Biotech

South Korea

Lantz Mackey

Director - CAR-T Process Development

Galapagos

Netherlands

Leopold Bertea

Chief Technology Officer

Mendus AB

Netherlands

Lilian Hook

Director Cell, Apheresis and Gene Therapies

NHS Blood and Transplant

United Kingdom

Lindsay Davies

CSO

NextCell Pharma

Sweden

Michael von Forstner

Head of Safety Science

Sobi - Swedish Orphan Biovitrum AB

Olga Sarnowska

Director, CMC Cell Therapy

Bristol Myers Squibb

Switzerland

Pierre Heimendinger

CTO

SmartImmune

France

Ramiz Saramati

MSAT Scientist, Cell & Gene Therapy

Novartis

Switzerland

Roman Necina

Chief Operating Officer

Hookipa Pharma

Austria

Sameer Hadawale

Gene Therapy Process Scientist

UCB

Belgium

Sebastian Schneider

Head of E2E Cell & Gene Value Chain

Roche

Switzerland

Sébastien Oster

Head of Pharmaceutical Development

SmartImmune

France

Simone Steiner

Chief Technical Operations Officer

T-Knife

Switzerland

Thomas Villiger

Prof. Bioprocess Technology

University of Applied Sciences and Arts Northwestern

Switzerland

Toni Cathomen

Director, Institute for Transfusion Medicine and Gene Therapy

University Medical Centre Freiburg

Germany

Uwe Buecheler

Senior Advisor Biopharmaceuticals

Boehringer Ingelheim

Germany

Yen Choo

Founder & Chairman, Assoc. Professor of Stem Cell Science and Regenerative Medicine

Plasticell Ltd, Lee Kong Chian School of Medicine

Singapore

DELEGATE REGISTRATION

Local Biopharmas (DACH region) , Academics & Research Institutes

From £1250

Standard Rate (valid from 01 November - 31 January 2025)
£1250.00 ex VAT

Final Call (valid from 01 February 2025 - 10 February 2025)
£1450.00 ex VAT

*Local Biopharma and Academia pricing is intended for Biopharma companies headquartered in the DACH region, as well as for Academic and Research Institutes

**Value Added Tax (VAT) exemptions will be applied where applicable in accordance with relevant regulations

International Biopharma

From £1550

Standard Rate(valid from 01 November - 31 January 2025) 
£1550.00 ex VAT 

Final Call (valid from 01 February 2025 - 10 February 2025) 
£1750.00 ex VAT

*International Biopharma pricing is intended for Biopharmas headquartered outside the DACH region

**Value Added Tax (VAT) exemptions will be applied where applicable in accordance with relevant regulations

Big Pharma

From £2450

Standard Rate(valid from 01 November - 31 January 2025) 
£2450.00 ex VAT 

Final Call (valid from 01 February 2025 - 10 February 2025) 
£2650.00 ex VAT 

*Big Pharma Pricing is intended for global pharmaceutical companies focused on drug development, research, and healthcare solutions

**Value Added Tax (VAT) exemptions will be applied where applicable in accordance with relevant regulations

Technology, Service, & Solution Providers

View the Prospectus

Cell & Gene Therapy Manufacturing 2025 is not limited only to biopharma and big pharma; representatives of service, solution, and technology providers are welcome to attend.

Reach out today and download the prospectus for detailed information on attendee options, sponsorship opportunities and benefits, and how to maximise your presence at #CGTM2025

Get in touch by e-mail: [email protected]

DELEGATE REGISTRATION

Catch the limited super access in time to save BIG!

Local Biopharmas (DACH region) , Academics & Research Institutes

From £1250

Standard Rate (valid from 01 November - 31 January 2025)
£1250.00 ex VAT

Final Call (valid from 01 February 2025 - 10 February 2025)
£1450.00 ex VAT

*Local Biopharma and Academia pricing is intended for Biopharma companies headquartered in the DACH region, as well as for Academic and Research Institutes

**Value Added Tax (VAT) exemptions will be applied where applicable in accordance with relevant regulations

International Biopharma

From £1550

Standard Rate(valid from 01 November - 31 January 2025) 
£1550.00 ex VAT 

Final Call (valid from 01 February 2025 - 10 February 2025) 
£1750.00 ex VAT

*International Biopharma pricing is intended for Biopharmas headquartered outside the DACH region

**Value Added Tax (VAT) exemptions will be applied where applicable in accordance with relevant regulations

Big Pharma

From £2450

Standard Rate(valid from 01 November - 31 January 2025) 
£2450.00 ex VAT 

Final Call (valid from 01 February 2025 - 10 February 2025) 
£2650.00 ex VAT 

*Big Pharma Pricing is intended for global pharmaceutical companies focused on drug development, research, and healthcare solutions

**Value Added Tax (VAT) exemptions will be applied where applicable in accordance with relevant regulations

Technology, Service, & Solution Providers

View the Prospectus

Cell & Gene Therapy Manufacturing 2025 is not limited only to biopharma and big pharma; representatives of service, solution, and technology providers are welcome to attend.

Reach out today and download the prospectus for detailed information on attendee options, sponsorship opportunities and benefits, and how to maximise your presence at #CGTM2025

Get in touch by e-mail: [email protected]

FEATURED CONTENT

CGT DACH Region Distribution Map

Blueprint Of Success: Download CGTWS Previous Event Report

Optimizing Cell & Gene R&D, Streamlining Manufacturing, and Expanding Market Access in Europe

CDMO Geographical Distribution Infographic

[Webcast] Advancing Cell & Gene Therapy: Current Landscape and Future Outlook

Revolutionizing Healthcare: Cell & Gene Therapy In UK

CONCEPT

FEATURED CONTENT

THANK YOU TO OUR SUPPORTING PARTNERS

2025

SPEAKERS

Abi Abitorabi

VP Cell & Gene Platform Implementation

Alberto del Río Espínola

Director in Toxicology

Alois Jungbauer

Professor, Institute of Bioprocess Science and Engineering, Department of Biotechnology

Arindam Mitra

Director CMC

Carl DeLuca

VP Technical Development & Global CMC Project Mgmt

Dirk Boehm

Head Cell and Gene Therapy CMC & Industrialization

Farzin Farzaneh

CSO & Chair of Molecular Medicine

Jae-Gyun Jeong

President

Joshi Venugopal

Senior VP - Head of Europe, Novartis Gene Therapies & Rare Diseases

Kostadinka Lilova

VP Process Research

KwangJun Yoon

Managing Director

Lantz Mackey

Director - CAR-T Process Development

Leopold Bertea

Chief Technology Officer

Lilian Hook

Director Cell, Apheresis and Gene Therapies

Lindsay Davies

CSO

Michael von Forstner

Head of Safety Science

Olga Sarnowska

Director, CMC Cell Therapy

Pierre Heimendinger

CTO

Ramiz Saramati

MSAT Scientist, Cell & Gene Therapy

Roman Necina

Chief Operating Officer

Sameer Hadawale

Gene Therapy Process Scientist

Sebastian Schneider

Head of E2E Cell & Gene Value Chain

Sébastien Oster

Head of Pharmaceutical Development

Simone Steiner

Chief Technical Operations Officer

Thomas Villiger

Prof. Bioprocess Technology

Toni Cathomen

Director, Institute for Transfusion Medicine and Gene Therapy

Uwe Buecheler

Senior Advisor Biopharmaceuticals

Yen Choo

Founder & Chairman, Assoc. Professor of Stem Cell Science and Regenerative Medicine

DELEGATE REGISTRATION

DELEGATE REGISTRATION

Catch the limited super access in time to save BIG!

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#BUZZ ABOUT THE EVENT

Register Now. SAVE BIG!

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