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3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit

  • 16th – 17th November 2022

The gene and cell therapies clinical impact, production, and processes efficiency depend on the unique challenges related to CMC, analytical, process development, automation, manufacturing, facility design, aseptic processing, supply chain and others that developers of gene and cell therapies must resolve.

At the 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit on November 16-17, 2022, key therapies experts, advisers, and practitioners will focus primarily on:

  •  Critical aspects of establishing an efficient, consistent, and flexible CMC strategy
  •  Controlling a product’s CQAs by controlling the process’ CPPs
  •  Emerging technologies improving effectiveness and CGTPs manufacturing processes and production
  •  Major considerations of easing the complexity of vector development and production
  •  Crucial components of controlling and scaling manufacturing process and operations for CGTPs

The #VLGeneCell brochure 2022 contains additional info and the key insights of the gene and cell therapies breakthroughs and advancements, as well as information about the concurrent #VLaseptic.

Read more

About the Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit

Gene and cell therapies breakthroughs are advancing rapidly.

Autologous and allogenic cell-based therapies, including CAR-T, TCR, NK-cells, TIL, viral and non-viral vector mediated therapies, and other ATMPs demonstrate tremendous progress.

The full extent of their clinical impact, production, processes performance, and efficiency hardly depend on the unique challenges related to CMC, analytical, process development, automation, manufacturing, facility design, aseptic processing, supply chain and others that developers of gene and cell therapies must resolve.

At the #VLGeneCell Summit, key experts, advisers, and practitioners will focus primarily on:

  •  Critical aspects of establishing an efficient, consistent, and flexible CMC strategy
  •  Controlling a product’s CQAs by controlling the process’ CPPs
  •  Emerging technologies improving effectiveness and CGTPs manufacturing processes and production
  •  Major considerations of easing the complexity of vector development and production
  •  Crucial components of controlling and scaling manufacturing process and operations for CGTPs certifying that:
    • Manufacturing process met technical and regulatory standards for producing safe and efficient gene and cell therapy products
    • High CGT product quality is achieved
    • Commercially viable CGTP are delivered

The leading gene and cell therapies practitioners and consultants will share insights, technical and regulatory requirements, and expectations on successfully achieving and scaling-up robust, cost- and quality-efficient products, process developments, and manufacturing, as well as explore recent developments, emerging technologies, methods, and tools, including the updates on the aseptic processing at the concurrent event.

Join the #VLGeneCell to explore the industry challenges, standards, and advancements on November 16-17, 2022, and take an advantage of the concurrent #VLaseptic.

Who should attend

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

  • Adenovirus
  • Adeno-Associated Virus (AAA)
  • Advanced Therapy Medicinal Product (ATMP)
  • Analytics
  • Analytical
  • Bioprocessing
  • Biotherapeutics
  • Chimeric Antigen Receptor T Cells (CAR-T)
  • Cell Engineering
  • Cell Therapy
  • Cellular Immunotherapy
  • Cellular Therapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • Commercialisation
  • Comparability
  • Compliance
  • Gene Therapy
  • GMP (Good Manufacturing Practices)
  • Gene Therapy Medicinal Products (GTMPs)
  • Cell-Based Medicinal Products (CBMPs)
  • Immuno-Oncology
  • Immunology
  • Immunology Chemistry
  • Immunotherapy
  • Lentivirus (LV)
  • Manufacturing
  • Market Access
  • Medical Affairs
  • Non-Viral Vectors
  • Oncology
  • Product Characterisation
  • Process Development
  • Production Engineering
  • Quality Assurance
  • Quality Control
  • Research and Development (R&D)
  • Regenerative Medicine
  • Regulatory
  • Safety
  • Scale Up
  • Stem Cell
  • Supply Chain
  • Tumor-infiltrating lymphocytes (TILs)
  • Viral Vector

The demand of aseptic manufacturing is rising, and, therefore, the challenges of aseptic processing will continue to grow in complexity.

Ensuring product quality at faster speed and with better flexibility is becoming the key priority.

The Annex 1 of the EU GMP Guide "Manufacture of Sterile Medicinal Products" is considered to be the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The changes to Annex 1 are bringing new obstacles to pharma company operations that should be overcome from both technical and organisational perspectives.

The 6th Aseptic Processing Summit on November 17-18, 2022, will bring together pharmaceutical developers, manufacturers, CDMOs, suppliers, engineering companies, and experts from the field to highlight:

  •  Regulatory updates and expectations on compliant aseptic production
  •  Important insights, best practices, and critical considerations on managing aseptic operations
  •  Innovative aseptic processing technologies and technics
  •  Aseptic manufacturing processes for ATMPs, including cell and gene therapies, and mRNA vaccines
  •  Advances in ATMP facility design and other emerging subjects, aimed to:
    • Achieve improvement in aseptic processing of sterile biopharma products
    • Ensure safe highly potent aseptic production for manufacturers
    • Provide patients with contaminant-free drug products that are effective and safe

Join the #VLaseptic to explore the industry challenges, standards, and advancements, as well as develop new partnerships and showcase innovative technologies at the premium conference and exhibition on November 17-18, 2022.

Who should attend

Chief Executives, Directors, Vice Presidents, Heads, Leaders, Senior Managers, Scientists, Chemists, Engineers, and Fellows specialising in:

  •  Advanced Therapy Medicinal Products (ATMP)
  •  Antibody
  •  Antibody-Drug Conjugates (ADCs)
  •  Artificial Intelligence
  •  Aseptic Container-Closure Systems
  •  Aseptic Filling
  •  Aseptic Manufacturing
  •  Aseptic Operations
  •  Aseptic Processing
  •  Aseptic Processing Equipment
  •  Aseptic Production
  •  Autoclave Cycles
  •  Automation
  •  Bags
  •  Barriers
  •  Bioburden
  •  Biologics
  •  Bioprocess
  •  Biosimilars
  •  Biotechnologies
  •  Cell and Gene Therapies (CGTs)
  •  Cell Manufacturing
  •  Chemistry, Manufacturing & Controls (CMC)
  •  Clean Room Operations
  •  Cleaning
  •  Cleaning Validation
  •  Clinical Manufacturing
  •  Cold Chain
  •  Commercial Sterilization
  •  Container Development
  •  Contaminant-Free Drug Products
  •  Contamination Control
  •  Continuous Manufacturing
  •  Continuous Processing
  •  Coronavirus
  •  Covid-19
  •  Depyrogenation
  •  Disinfection
  •  Drug Development
  •  Drug Safety
  •  Dry Heat Sterilization
  •  Engineering
  •  Engineering
  •  Environmental Monitoring
  •  Enzyme-Indicators
  •  Ethylene Oxide Sterilization
  •  Facilities
  •  Facility Design
  •  Fill and Finish
  •  Filters
  •  Final Filling
  •  Food Packaging
  •  Formulation
  •  Freeze Drying
  •  Generics
  •  Good Manufacturing Practice (GMP)
  •  High Potent Processing
  •  Highly Potent Active Pharmaceutical Ingredients (HPAPI)
  •  Highly Potent Substances
  •  Hydrogen Peroxide (H2O2)
  •  Industrial Hygiene
  •  Integrity Testing
  •  Isolation Technologies
  •  Isolators
  •  Labelling
  •  Leak Testing
  •  Lesser-Used Techniques
  •  Lyophilisation
  •  Machine Learning
  •  Media Fills
  •  Medical Devices
  •  Messenger RNA (mRNA)
  •  Microbiological Lethality
  •  Microbiologic
  •  Modular Filling
  •  Nanomaterials
  •  Packaging Technology
  •  Parenterals
  •  Pharmaceutical Process
  •  Pharmaceutical Technology
  •  Pharmaceutical Water
  •  Pharmaceuticals
  •  Predictive Modelling
  •  Process Analytics
  •  Process Control
  •  Process Monitoring
  •  Process Simulation
  •  Process Validation
  •  Processed Foods
  •  Product Innovation
  •  Pure Steam Generators
  •  Quality Assurance ( QA)
  •  Quality Control (QC)
  •  Quality Risk Management
  •  Radiation
  •  Radiation Sterilization
  •  Rapid Micro Testing
  •  Regulatory
  •  Regulatory Affairs
  •  Research & Development (R&D)
  •  Restricted Access Barrier Systems (RABS)
  •  Risk Management
  •  Robotics
  •  Single Use Manufacturing Systems
  •  Single-Use Components
  •  Small Scale
  •  Stability
  •  Sterile Biopharma Products
  •  Sterile Medicinal Product
  •  Sterility Testing
  •  Sterilization
  •  Supply Chain
  •  Syringes
  •  Terminal Sterilization
  •  Testing
  •  Toxicology
  •  Tubing
  •  Vaccines
  •  Validation
  •  Virtual Reality

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

  • Accelerating progress, CMC, and quality development of gene and cell therapies (GCT) products
  • Meeting consistent CGTP safety and efficiency criteria, regulatory and GMP manufacturing standards
  • Optimising and scaling vector production processes and performance
  • Enabling new technologies and processes coupled with sophisticated CQAs

Dr. Amandine Breton, UK

Associate Director of Cell Process MSAT

Orchard Therapeutics

Amandine Breton is associate director of cell process MSAT at Orchard Therapeutics. In 2019 she joined Orchard Therapeutics, where she oversees and manages cell and gene therapy drug product manufacture from pivotal clinical trials to commercial, including authoring of regulatory filings (IND, IMPD, MAA, BLA). In addition to her MSAT responsibility, she has been leading the Strimvelis® CMC team since 2020. Amandine has a BSc and MSc from the University of Versailles St-Quentin (UVSQ) and a PhD in cellular biology from UVSQ. She did three post-docs at the Roslin Institute, Queen’s Mary University, and King’s College London, working in induced pluripotent stem cells biology, hematopoietic cells, and globin gene activation in the context of beta-thalassaemia and sickle-cell disease. She then chose to join the CGT field and held two consecutive positions in GMP manufacture at Guy’s and St Thomas GMP unit and CRUK GMP manufacture, where she worked on autologous and allogenic cell therapies in phase I/II clinical trial, building her expertise in technology transfer, process development, and GMP manufacturing processes.

Dr. Pranav Puri, NL

Sr. Scientist, BioProcess Development , Next Generation Therapeutics

VectorY

Dr. Behnam Ahmadian Baghbaderani, US

Executive Director, Global Head of Process Development, Cell and Gene Technologies

Lonza

Dr. Houria Bachtarzi, UK

Associate Director, Regulatory Affairs - CMC - Gene and Cell Therapies

ProPharma Group

Dr. Houria Bachtarzi is an Associate Director, Regulatory Affairs - CMC - Gene and Cell Therapies, with 15 years of experience in the scientific and regulatory CMC aspects of advanced biological therapies including virally vectored gene therapy, in vivo and ex vivo gene editing, cell-based immunotherapy, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, and stem cell-based therapies. Houria started her career by first training and registering as a pharmacist in the UK, before embarking into a unique journey in gene therapy and regenerative medicine. She 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 neuro-muscular 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, Houria was appointed as a lecturer in biopharmaceutics and biotechnology at the School of Pharmacy and Biomolecular Sciences, University of Brighton.

Prior to joining Diamond BioPharm Ltd., a ProPharma Group Company, Houria was a senior consultant in gene and cell therapies at other product development and regulatory consultancies: ERA Consulting (UK) Ltd., NDA Group and Dark Horse Consulting, where she provided technical scientific, CMC, and regulatory/development strategic advice in relation to different complex gene and cell therapy technologies. She also provided expert advice on matters related to genetically modified organisms (GMOs). 

Dr. Angeliki Grammenos, BE

Senior Regulatory Manager

Celyad Oncology SA

Angeliki Grammenos is a physicist by training and has a PhD in biophysics specialized in cell biology. She has held positions in academia and biopharma, with a special focus in cell therapy. In 2012, she left her teaching position at the University of Liège to join the international office of Doctors Without Borders, where she assisted the ethical review board as well as the quality assurance department of the organization. In 2015, she left to lead the regulatory department at Bone Therapeutics S.A, a biopharmaceutical company dedicated to the development of cell therapy products based on autologous and allogeneic adult stem cell technology to treat unmet medical needs in the field of bone disease. In 2018, Angeliki joined Celyad Oncology, a biopharmaceutical company developing a diversified pipeline of allogeneic and autologous CAR-T cell therapy candidates for cancer patients with hematological malignancies and solid tumors.

Dr. Kuldip Sra, US

Executive Director / Tech Ops

Crispr Therapeutics

Dr. Kuldip Sra has over 25 years of work experience in biotech and pharmaceutical industries. Currently, Kuldip is executive director in tech ops at Crisper Therapeutics. Previously, he worked at Kite Pharma/Gilead, where he was director of QC. Kuldip is involved in developing and validating analytical assays for lot release and characterisation of autologous and allogenic cell therapy drug products.

In the past, he worked at MedImmune/AstraZeneca for 15 years. Kuldip led the vaccine analytical development and characterisation group at MedImmune at its Mountain View site.

Dr. Carmen Brenner, BE

Director of Quality

NOVADIP Biosciences S.A.  

Sara Mills, US

Principal

Dark Horse Consulting Inc.

Dr. Kyle Grant, US

Director of Vector Production

Voyager Therapeutics, Inc.

Dr. Rajeev Boregowda, US

Director, Analytical Development

Solid Biosciences Inc.

Dr. Rahul Kaushik, UK

Group Leader - AAV-Exosome vector production

Evox

Dr. Amandine Breton, UK

Associate Director of Cell Process MSAT

Orchard Therapeutics

Dr. Pranav Puri, NL

Sr. Scientist, BioProcess Development , Next Generation Therapeutics

VectorY

Dr. Behnam Ahmadian Baghbaderani, US

Executive Director, Global Head of Process Development, Cell and Gene Technologies

Lonza

Dr. Houria Bachtarzi, UK

Associate Director, Regulatory Affairs - CMC - Gene and Cell Therapies

ProPharma Group

Dr. Angeliki Grammenos, BE

Senior Regulatory Manager

Celyad Oncology SA

Dr. Kuldip Sra, US

Executive Director / Tech Ops

Crispr Therapeutics

Dr. Carmen Brenner, BE

Director of Quality

NOVADIP Biosciences S.A.  

Sara Mills, US

Principal

Dark Horse Consulting Inc.

Dr. Kyle Grant, US

Director of Vector Production

Voyager Therapeutics, Inc.

Dr. Rajeev Boregowda, US

Director, Analytical Development

Solid Biosciences Inc.

Dr. Rahul Kaushik, UK

Group Leader - AAV-Exosome vector production

Evox

BROCHURE

Request the 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit brochure and find out the latest topics and ideas that will be shared.

Request

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What our
participants
are saying

It was a well-prepared, practical review of the major issues affecting the cell and gene therapy area, with recommendations from the experts in the field of CGTPs.

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Past

Attendee

This conference brought many opportunities to exchange the contacts and the recent cases in the field.  Must attend for those looking to overcome the numerous challenges in the process of gene and cell therapies development and manufacturing.

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Past

Attendee

The success of this summit & exhibition is in the excellent speakers board, emerging and critical topics, and networking opportunities. I will be glad to attend it again.

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Past

Attendee