Fraunhofer Translational Center Regenerative Therapies TLC-RT
Fraunhofer Translational Center Regenerative Therapies TLC-RT

© K.Dobberke für Fraunhofer ISC

Clinical Development

Fraunhofer Translational Center Regenerative Therapies TLC-RT investigates new ways in the treatment of particular diseases of the joints, the immune system and the cardiovascular system as well as tumors and wound care. This includes the use of biotechnologically processed tissue products such as cartilage implants or cellular products such as mesenchymal stem cells. The combination of innovative biomaterials can improve tissue and organ properties. Besides developing novel medicinal products and medical devices, TLC-RT competently supports industrial partners meeting regulatory requirements for the manufacture, application and approval of their products.

 

Current Foci

Preclinical testing of medical devices and innovative pharmaceuticals

  • High-resolution imaging performed on small animal models including bioluminescence, multispectral fluorescence-, radioisotope-, Cherenkov-, and high-resolution x-ray imaging
  • Biodistribution- and tumorigenicity studies according to GLP standards
     

Development of biological 3D matrices for clinical use

  • Fabrication of biological 3D matrices for medical coverage of defects and defect replenishment (BioVaSc-TERM™)
  • Manufacturing of Advanced Therapy Medicinal Products (ATMPs) fulfilling GMP compliance for human applications
     

Development of incubators for the production and transport of 3D models

  • Transport of complex tissues in a mobile incubator under standardized and recordable conditions
     

Regulatory framework for the manufacture, clinical application and authorization of medical devices and Advanced Therapy Medicinal Products (ATMPs)

  • Implementation of regulatory requirements for the GMP, GLP, GCP-compliant manufacture and testing of medical devices and pharmaceuticals

 

Expertises

  • GMP compliant manufacturing of medical devices and ATMPs
  • Preclinical testing on small animal models (DIN ISO 10993-6 and GLP-like standard compliant)
  • In vivo imaging for preclinical testing
  • Implementation of regulatory requirements for Quality Management (QMS) and Data Management System (DMS) for the manufacture and approval of medical devices and ATMPs
  • Preparation, support and assistance of manufacturers in regulatory consultations and applications (Scientific Advice)
  • Contractual design in the field of manufacturing and clinical testing
  • Design and maintenance of essential documents in clinical trials (CTD, IMPD, IB, a. o.)

 

Service for Customers

Preclinical

  • GLP- or DIN ISO-compliant preclinical development and testing of medical devices and ATMPs
  • Preclinical efficacy studies
     

Manufacturing

  • Production of medical devices, novel drugs, and ATMPs under GMP compliance (AMG § 13 and AMWHV)
  • Tailor-made development of customized QMS and DMS for the manufacturing, clinical testing and approval of medical devices and ATMPs
     

Transport

  • Tailor-made validated transport solutions (suitable for complex medical products and ATMPs)
     

Regulatory Affairs

  • Preparation, organization and support during official consultations and applications
  • Contractual design in the field of manufacturing and clinical testing
     

Preparation and maintenance of study-specific essential documents (CTD, IMPD, IB)

  • Regulatory support for importing materials for the production of ATMPs (AMG §72 b)
  • Regulatory support in the application for procurement authorizations (AMG §20 b / c)
  • Mediation of competent clinics (local, national and international) for the execution of clinical trials, also according to the new Medical Device Regulation (MDR)