Pharma
The 5th Gene & Cell Therapy CMC: Process Development, Quality & Vector Manufacturing Summit is dedicated to accelerating progress in the CMC, quality, and manufacturing readiness of next-generation gene and cell therapy (GCT) products.
Gain practical insights into meeting CGTP safety and efficacy requirements, navigating evolving regulatory and GMP expectations, and optimizing end-to-end vector development and production.
Explore the latest technologies transforming GCT manufacturing—from digital and automated platforms to advanced analytics and CQAs that strengthen control, consistency, and scalability.
Join leaders in GCT development at the #EGeneCell Berlin in May 2026 to improve process robustness, enhance product quality, and accelerate translation from development to commercial scale.
Read moreJoin leading developers, manufacturers, and regulators at the 5th Gene & Cell Therapy CMC: Process Development, Quality & Vector Manufacturing Summit, taking place May 19–20, 2026 in Berlin, 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.
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:
This event is designed to equip teams with actionable solutions to scale complex therapies while safeguarding quality, safety, and regulatory compliance.
New expectations for potency assays, comparability, and raw material control are increasing CMC complexity.
Challenges include:
Supply constraints and technical bottlenecks remain in plasmids, capsids, and critical materials used in IVT and viral production.
Qualification, dual sourcing, and vendor management are becoming strategic priorities.
Long lead times, non-standardized potency assays, and growing testing requirements are slowing release timelines.
Many manufacturers struggle to implement digital CMC, data integration, and automated workflows despite clear regulatory and economic benefits.
Real-world lessons from biotech, pharma, regulators, and CDMOs.
Process development, analytics, comparability, CQAs, vector engineering, and closed-system manufacturing.
Regulatory harmonization, scalability, cost-of-goods reduction, and digital transformation.
Meet CMC, QA/QC, MSAT, manufacturing, regulatory, and process experts shaping the CGT industry.
Discover cutting-edge tools for vector production, automation, analytics, and next-generation bioprocessing.
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:
Gene & Cell Therapy Modalities
CMC, Process & Manufacturing
Quality, Safety & Regulatory
Analytics & Innovation
R&D, Clinical & Commercial
The 5th Gene & Cell Therapy CMC Summit is the premier platform for staying ahead in process development, quality, regulatory strategy, and manufacturing innovation.
If you are working to develop, scale, or commercialize gene and cell therapies, this summit will deliver the insights, solutions, and partnerships essential for success.
Secure your place at #EGeneCell 2026 in Berlin and be part of the community advancing the future of gene and cell therapy manufacturing.
The Early Bird Offer expires in 23 days!
To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.
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.
Learn how to align processes with evolving expectations from EMA, FDA, MHRA, and global agencies. Gain insights into:
Understand new strategies for improving productivity, reducing cost of goods, and addressing bottlenecks in:
See how digital twins, AI-enabled monitoring, PAT, real-time release, and high-throughput analytics are reshaping CGT manufacturing efficiency and reducing failure risk.
The Early Bird Offer expires in 23 days!
About Speaker
About Speaker
Gene Therapy Consultancy
About Speaker
About Speaker
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).
Before taking a position in Novadip, Dr. Carmen Brenner, who received her PhD in biomedical science, was an R&D project manager at Bone Therapeutics. Later, Carmen became head of the QC department, first as manager and then as associate director.
Gene Therapy Consultancy
Dr. Rahul Kaushik is the Founder of Gene Therapy Consultancy, a firm dedicated to accelerating the preclinical development of AAV-based gene therapies. With a mission to democratize specialized AAV knowledge and overcome critical developmental barriers, Dr. Kaushik and his team of AAV experts strive to expedite the delivery of life-saving treatments to patients. Dr. Kaushik possesses extensive expertise in AAV-based in vivo gene therapy product development across diverse disease areas. He has significantly contributed to advancing AAV and Lentiviral-based platform technologies and programs for gene silencing and supplementation strategies within various organizations. With over 16 years of experience, Dr. Kaushik has authored numerous high-impact publications and is committed to advancing effective gene therapies for human diseases through the utilization of advanced viral vectors and improved manufacturing processes.
Dr Houria Bachtarzi is the Principal Consultant of BIOCELLGENE Consulting Ltd., with strong expertise in the development and regulatory strategic aspects of advanced biological therapies covering virally vectored gene therapy, in vivo and ex vivo gene editing, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, cell-based immunotherapy, stem cell-based therapies; as well as other innovative therapeutic modalities.
She started her career by first training and registering as a pharmacist in the UK; and completed her PhD in cancer gene therapy at the University of Oxford, Department of Oncology (previously Department of Clinical Pharmacology). She subsequently followed up with additional Post-Doctoral work in AAV-based gene therapy and shRNA therapeutics for degenerative neuromuscular disorders at the Centre for Biomedical Sciences, Royal Holloway – University of London, in collaboration with Benitec Biopharma, Inc. and the Institute of Myology at the Pitié-Salpétrière Hospital in Paris, France. In 2013, she was appointed as a Lecturer in Biopharmaceutics at the School of Pharmacy and Biomolecular Sciences, University of Brighton.
Prior to founding BIOCELLGENE Consulting Ltd., Houria was a Director of CMC Regulatory Affairs (Consultancy) at Precision for Medicine, acting as an internal (for the Company) and external subject matter expert, to support organisations developing cell and gene therapy products and biologics for rare diseases and oncology indications. She also held senior positions at different product development and regulatory consultancies, notably Associate Director of Regulatory Sciences/ATMP Subject Matter Expert at ProPharma Group (formerly Diamond Pharma Services) and Senior Consultant positions at ERA Consulting (now Cencora PharmaLex), NDA Group and Dark Horse Consulting.
Houria is a registered Pharmacist with the General Pharmaceutical Council in the UK. She is also a member of the British Society for Gene and Cell Therapy (BSGCT), the American Society of Gene and Cell Therapy (ASGCT) and the International Society for Cell and Gene Therapy (ISCT).
Gene Therapy Consultancy
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