Advanced Therapy Medicinal Products (ATMP)

Supporting you from discovery to therapy, matching expertise, reducing risk.

Advanced Therapy Medicinal Products (ATMP) represent a new category of medicines with a wide therapeutic potential for treating different types of diseases such as cancer, neurode­generative and cardiovascular diseas­es. They include Gene Therapy Medicinal Products (GTMP), Cell Therapy Medicinal Products (CTMP), and Tissue Engineered Products (TEP). Clinical application of the two latter types is frequently referred to as ‘Regenerative Medicine’.

EATRIS ATMP platform offers over 35 state ­of­ the ­art European centres covering the entire ATMP production and development pipeline.

The platform provides the most qualified and state ­of­ the ­art technologies for the critical issues in this development area, such as specialised GMP facilities, imaging facilities for in vivo animal studies, availability of dedicated/ tailored animal models, clinical expertise and access to patients for high prevalence and/or rare diseases, as well as to clinical facilities.

The platform includes a network of experts for regulatory affairs special­ised in the ATMP field to ensure compliance with the pre­clinical and clinical development guidelines within Europe.

EATRIS ATMP services facilitate project advancement in the minimum of time and with the most efficient use of resources, while also ensuring high levels of scientific discipline and regulatory expertise.

Expertise

  • Key opinion leaders in cell and gene therapy as well as in tissue engineering.
  • Interaction between clinicians and specialised scientists, biotechnologists, biostatisticians in close coordination with regulatory affairs experts and national authorities throughout ATMP development.
  • Experience in many disease areas ranging from oncology or neurodegenera­tive disorders to regenerative medicine.

 

Target revalidation and pre-clinical development

  • State of the art genomics, proteomics platforms.
  • State of the art vectorology, cell biotechnology.
  • Animal facilities up to BSL3 containment with large range of animal models and species.
  • Pre­clinical imaging (μPET, μCT, μMRI, US, μSPECT, optical imaging as well as hybrid systems) to re­validate the target.
  • Assessment of the regulatory require­ments for future clinical development.

GMP production of ATMPs

  • GMP pharmaceutical plants authorised by the local competent authorities.
  • Production of a great variety of all types of ATMP for human use.

Toxicology

  • Evaluation of general safety and efficacy for the application in clinical studies.
  • GLP compliant facilities for toxicology in rodents, rabbits and pigs.

Clinical development

  • Local clinical trial centres to cover phase I and II clinical studies jointly with university medical centres to foster interactions between clinicians and specialised scientists.
  • Support of the trial design and execution under GCP.
  • Clinical imaging for image acquisition, analysis, integration and interpretation in various patient cohorts.
  • Data analysis centres to handle, process, integrate and store multimodality data.
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