Fraunhofer-Institut für Zelltherapie und Immunologie IZI
Target Group
This event is designed for professionals involved in the development and delivery of advanced therapy medicinal products (ATMPs), including experts in the supply chain and logistics, quality and regulatory affairs, manufacturing and quality control (QC), treatment center staff and project managers from biotech, pharma, and academic institutions working with cell and gene therapies.
Objectives
Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, represent a distinct class of medicinal products as defined under Regulation (EC) No 1394/2007 and are subject to specific regulatory, quality, and safety requirements. While these therapies offer significant therapeutic potential, their development and commercialization are associated with a high level of complexity throughout the entire supply chain. From donor collection or patient apheresis to manufacturing, quality control, storage, transport, regulatory release, and bedside administration, ATMPs challenge established pharmaceutical supply chain models.
The individualized nature of many ATMPs, particularly autologous therapies, results in small batch sizes, limited shelf life, and stringent requirements for temperature control, traceability, and segregation. Compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and applicable GxP guidelines necessitates strict implementation of chain of identity and chain of condition concepts to ensure product quality, patient safety, and regulatory compliance across all supply chain steps.
This event provides a structured overview of the ATMP supply chain, addressing scientific, technical, regulatory, and operational aspects in accordance with EU and international regulatory frameworks. It covers autologous, allogeneic, and in vivo gene therapies and examines how their specific characteristics influence logistics design, manufacturing strategies, and quality systems. Key topics include storage and transport temperature strategies, cryogenic versus non-cryogenic supply chains, regulatory challenges related to EU importation, Qualified Person (QP) release, dangerous goods classification under ADR/IATA, and the use of digital solutions to support traceability, monitoring, and orchestration.
The objective of this event is to provide participants with a comprehensive understanding of ATMP supply chain requirements and practical solutions. Through expert insights, real world case studies and experience reports from industry and treatment center, attendees will learn how to design scalable, compliant, and patient centric supply chains. The event aims to foster cross functional understanding, support informed decision making and encourage collaboration among stakeholders involved in bringing ATMPs safely and efficiently from vein to vein.
Programme
Introduction and Overview of Cell & Gene Therapies
What are ATMPs?
Types of ATMPs and their status of today
Supply chain of allogeneic, autologous and in vivo gene therapies
Specific requirements of the ATMP supply chain
To Freeze or not to Freeze – Storage and Transport Temperatures of Cell Therapies
Pros and cons of freezing donations and cell therapies
How temperature and primary package impact stability and logistics feasibility
Examples and case studies of feasible and not feasible supply chain plans
Suggestions for a scalable ATMP supply chain
Regulatory Challenges and Solutions
Challenges of the EU ATMP regulations for the global ATMP supply chain
How to manage EU import and QP release of ATMPs
How to label and serialize investigational and commercial ATMPs
Centralized vs. Decentralized Manufacturing
Centralized Manufacturing Model
Vision of bed side treatment and steps to get there
Pre-Requisites and benefits of decentralized manufacturing
Small Batches in Patient-Specific Production – QC & Stability Testing
Sample Chain of Identity and Chain of Condition
Trade-offs between cost efficiency and throughput-time
Impact of mutual recognition agreements for ATMPs
Parallelizing activities for optimized vein-to-vein cycle
Quality Aspects and Challenges of the Supply Chain for IMP ATMP Manufacturing - An Eperience Report of an Academic CDMO
Raw materials - Quality requirements - Dual sourcing - Traceability - Chain of identity for cell material - Supplier qualification - (Raw) material management
Final product - Shipment requirements and examples
Solutions for the ATMP Supply Chain
The cryogenic supply chain – technical solutions and infrastructure requirements
How to assure time-critical ATMP shipments arrive safely at the treatment center
Digital solutions for orchestration and tracking of cell therapies
Dangerous Goods Classifications in the ATMP Supply Chain
What are dangerous goods and which classifications are used for ATMPs?
How to apply the classification UN3245 for genetically modified organisms for gene therapies
How to apply the classification UN3373 for infectious substances for donations and finished therapies
The consequences of a dangerous classification for the ATMP supply chain
Do not X-RAY ATMPs - Required Precaution or Unnecessary Roadblock?
Most ATMP’s are labelled with a “do not X-ray” label and should be exempted from X-ray scans at Airports
The X-ray exposure of ATMPs during transportation by airfreight
The consequences of the exemption of ATMPs from airport security scans
Physical and scientific background and solutions
Perspective of Advanced Therapy Treatment Centers Responsible for Apheresis and Administration
How does the quality of starting material influence the manufacturing process and final drug product quality?
How to optimize starting material quality?
How to handle the product bedside?
Points to consider for a collection and an application manual
Further Information
Technical Details To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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