• FAQs
  • Glossary
Close

FAQs

Why are some conditions more suitable for gene and cell therapies than others?
There is an approved treatment available for my condition - why can't I receive it?
How to look for approved medicines?
How are medicines developed and approved?

See all FAQs

Close

Glossary

Adeno-associated virus (AAV)
Adenovirus
Adult stem cells
Antibody
Antigen
Base editors
Cas9 nuclease
Chimeric Antigen Receptor (CAR)
Chromosome
Clinical trial

See full Glossary

Research Pathways

Bringing gene and cell therapies from the lab bench to patients is a complex process and multiple pathways exists. The Research Pathways directory contains resources to help various stakeholders interested in therapy development navigate this process. Research Pathways is centred around the legal and regulatory aspects for cell and gene therapy development in Europe and further expanded to additional aspects. It is free to use and all resources in this database are categorised for improved searchability.

How to use Research Pathways  EuroGCT's Key Resources

Additional navigation options

More ways to navigate Research Pathways

Filter by

Theme
Target audience
Region
Resource type
Organisation type
Conditions and diseases
Reset
Showing 10 of 11
EuroGCT Resource

Packaging and labelling of ATMPs

  • EU and UK
  • 2022
  • EuroGCT
Packaging and labelling (including outer packaging, the immediate packaging and the package leaflet) provide the information on an advanced therapy medicinal product (ATMP) to patients.  
Read this resource

Theme

  • Show all 1
  • Packaging and labelling
EuroGCT Resource

Manufacturing

  • EU and UK
  • 2022
  • EuroGCT
Advanced therapy medicinal products (ATMP) manufacturing concerns the industry-scale production of these therapies for supporting clinical development and commercialisation. This section provides an overview of the ATMP manufacturing processes, key terms, and related resources.
Read this resource

Theme

  • Show all 7
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling

Manufacturing process development of ATMPs within a regulatory framework for EU clinical trial & marketing authorisation applications

  • 2016
  • Cell And Gene Therapy Insights
In the European Union, the regulatory approval of ATMPs for use in patients requires that data demonstrating their quality, safety and efficacy are submitted in dossiers to regulatory agencies for review. Indeed, such dossiers have a specific format that, in the case of quality data in particular, is informative for the manufacturing process development strategy. This manuscript describes how dossier requirements can be implemented into the design of industrialized ATMP manufacturing processes and fulfilled to enable effective regulatory submissions.
Read this resource

Theme

  • Show all 10
  • Clinical research
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
EuroGCT Resource

Case Study: Holoclar

  • EU and UK
  • 2023
  • EuroGCT
Case Study on Holoclar: Holoclar is one of the few ATMPs that have been granted marketing authorisation in Europe. We collated existing information about each stage of development for Holoclar, from early-stage research to approval, for the research community to learn about its development process.
Read this resource

Theme

  • Show all 18
  • Research and Innovation
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Funding
  • Incentives
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Commercialisation
  • Market access for ATMPs

New guidance on the development and marketing of ATMPs in the UK and EU in the post-BREXIT landscape

  • UK
  • 2022
  • CGT Catapult
A guidance by the Cell and Gene Therapy Catapult (CGT Catapult) on the development and marketing of ATMPs in the UK and EU in the post-BREXIT landscape.
Read this resource

Theme

  • Show all 15
  • Clinical research
  • Translational Science
  • Early interaction with regulators
  • Therapy classification
  • Legal classification
  • ATMPs
  • Not ATMPs: Human body elements for therapeutic applications
  • Not ATMPs: medical devices containing tissues and cells
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Packaging and labelling
  • Market access for ATMPs
  • Distribution
  • Pharmacovigilance
  • Pricing & reimbursement

EMA Guidelines relevant for advanced therapy medicinal products

  • EU
  • European Medicines Agency (EMA)
Scientific guidelines developed by The European Medicines Agency (EMA) relevant for Advanced Therapy Medicinal Products (ATMPs).
Read this resource

Theme

  • Show all 13
  • Fundamental Research
  • Clinical research
  • Translational Science
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
  • Pharmacovigilance

The EBMT/EHA CAR-T Cell Handbook

  • EU
  • 2022
  • EBMT, EHA and Springer
This open access CAR-T Cell Handbook published by Springer and co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), provides an unparalleled overview of the CAR-T cell technology and covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues.
Read this resource

Theme

  • Show all 14
  • Fundamental Research
  • Clinical research
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
  • Distribution
  • Pharmacovigilance
  • Pricing & reimbursement
  • Ethics

ATMP Sweden Regulatory Guide

  • Sweden
  • ATMP Sweden
ATMP Sweden's regulatory guide for the development of the Advanced Therapy Medicinal Products (ATMPs)
Read this resource

Theme

  • Show all 12
  • Fundamental Research
  • Clinical research
  • Early interaction with regulators
  • Legal classification
  • ATMPs
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling

ARM Project A-Gene

  • Global
  • 2021
  • ARM
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) produced A-Gene, a case study-based guide to integrating Quality by design (QbD) principles in gene therapy Chemistry Manufacturing & Control (CMC) programs.
Read this resource

Theme

  • Show all 12
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Early interaction with regulators
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs

ARM Project A-Cell

  • Global
  • 2022
  • ARM
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) produced A-Cell, a case study-based guide to integrating Quality by design (QbD) principles in cell therapy Chemistry Manufacturing & Control (CMC) programs. 
Read this resource

Theme

  • Show all 12
  • Fundamental Research
  • Clinical research
  • Translational Science
  • Early interaction with regulators
  • Manufacturing
  • Manufacturing Authorisation
  • Good Manufacturing Practice
  • Investigational medicinal products dossier
  • Capability
  • Scalability
  • Packaging and labelling
  • Market access for ATMPs
Back to top
Did you find the content on this page useful? If not, you can leave us a message so we can improve Send us your thoughts