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Pre-Conference Day - Monday 2nd December, 2024 - GMT (Greenwich Mean Time, GMTZ)
Introduction
Group discussion : the challenges of Tech Transfer
Session 1 : Formal Aspects
- Tech Transfer as a project
- Regulatory constraints and concerns : product comparability
- Tech Transfer Documentation : Procedure, Protocol and Report
Session 2 : Tools for Technology Transfer
- Transfer of process information
Group exercise : improving information transfer
- Risk Analysis
- Importance of Communications
Group discussion : improving communication
Session 3 : Dealing with the Complexities of Tech Transfer
- Determinants of Complexity
- Process Scale Up
- Analytical Transfer
- Tech Transfer in the Life Cycle
Conclusions
- Thomas Chattaway - Senior Life Science Consultant, Independent
Relevant Regulatory Background in the Field of CGT and QbD
- Laws and Guidelines
- CMC requirements
- Definitions
Quality by Design (QbD) Concept and Approaches
- Gain a practical guidance to QbD
- How to apply QbD
- Step by step approach from Target Product Profile to critical process ranges
- Generation of product and process knowledge
- Learn how to link product and process characterization together
- Overview of development throughout the lifecycle
- Specificities to CGT
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Introduction
Group discussion : the challenges of Tech Transfer
Session 1 : Formal Aspects
- Tech Transfer as a project
- Regulatory constraints and concerns : product comparability
- Tech Transfer Documentation : Procedure, Protocol and Report
Session 2 : Tools for Technology Transfer
- Transfer of process information
Group exercise : improving information transfer
- Risk Analysis
- Importance of Communications
Group discussion : improving communication
Session 3 : Dealing with the Complexities of Tech Transfer
- Determinants of Complexity
- Process Scale Up
- Analytical Transfer
- Tech Transfer in the Life Cycle
Conclusions
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Different Risk management methods and tools
- Learn how to assess risks and managing the risks
- Linkage studies
- Examples for Failure Mode, Effect and Criticality Analyses (FMECA)
- Case studies in the field of CGT
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Introduction
Group discussion : the challenges of Tech Transfer
Session 1 : Formal Aspects
- Tech Transfer as a project
- Regulatory constraints and concerns : product comparability
- Tech Transfer Documentation : Procedure, Protocol and Report
Session 2 : Tools for Technology Transfer
- Transfer of process information
Group exercise : improving information transfer
- Risk Analysis
- Importance of Communications
Group discussion : improving communication
Session 3 : Dealing with the Complexities of Tech Transfer
- Determinants of Complexity
- Process Scale Up
- Analytical Transfer
- Tech Transfer in the Life Cycle
Conclusions
- Thomas Chattaway - Senior Life Science Consultant, Independent
Stages in Process Development:
- Examining design, qualification and validation - Discover what to do and when
- Pre-requisites to start production for clinical studies
- Product and Process development & characterization
- How to define preliminary critical quality attributes (pCQAs)
- Linkage studies of preliminary critical quality attributes (pCQAs) and preliminary critical process parameters (pCPPs)
Process Characterization:
- Small-scale process model definition and utilization
- Learn how to use small process models
- Statistical models
- Proven Acceptable Range studies & Design Space development
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Introduction
Group discussion : the challenges of Tech Transfer
Session 1 : Formal Aspects
- Tech Transfer as a project
- Regulatory constraints and concerns : product comparability
- Tech Transfer Documentation : Procedure, Protocol and Report
Session 2 : Tools for Technology Transfer
- Transfer of process information
Group exercise : improving information transfer
- Risk Analysis
- Importance of Communications
Group discussion : improving communication
Session 3 : Dealing with the Complexities of Tech Transfer
- Determinants of Complexity
- Process Scale Up
- Analytical Transfer
- Tech Transfer in the Life Cycle
Conclusions
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Process overview
- Objectives of main processing steps
- Cell lines (generation & characterization) - regulatory requirements
- Materials and risks
- Where processing under GMP needs to start?
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
*LIMITED SPACES LEFT*
Join us for a rare opportunity to explore St James's Hospital's Wellcome HRB Clinical Research Facility. Nestled within Ireland's largest teaching hospital, this cutting-edge facility stands at the forefront of medical innovation, leading the charge in groundbreaking early-phase clinical trials and studies. Witness first-hand the specialized infrastructure that has paved the way for revolutionary advancements, including Ireland's first gene therapy and CAR-T clinical trials.
During this tour, you will:
- Enjoy a warm welcome: Start your tour with complimentary refreshments, snacks, and a brief introduction to the facility.
- Access restricted areas: Delve into clinical consultation rooms, a dedicated ward, inpatient rooms, a sample processing laboratory, and a specialized research pharmacy equipped to store Investigational Medicinal Products (IMPs).
- An inside look: Experience the GMP-grade clean room, a sterile environment meticulously designed for the aseptic preparation of life-altering gene and cell therapies.
- Learn about ongoing projects: Gain insights into the diverse range of clinical trials currently underway, including CAR-T cell therapy for Multiple Myeloma, gene therapies for Haemophilia, and pioneering gene therapies for Neurological conditions.
Important Notes:
- Photography restrictions: Please respect patient privacy; photography is not permitted in patient areas.
- Guided experience: For your safety and to ensure a smooth experience, you will be accompanied by knowledgeable CRF staff throughout the tour.
Don't miss this unique chance to explore this cutting-edge facility. Spaces are limited, RSVP required!
*Transport provided from DCC to Site and back for attendees*
- Martina Hennessy - Director, Wellcome HRB Clinical Research Facility at St. James’s Hospital