EVTT

GMP - GMP Unit at SCI-TReCS

Director: Univ.-Prof. Dr. Eva Rohde

 

 

The GMP (= Good Manufacturing Practice) Unit of the Center for Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS) develops and manufactures new cell-based therapeutic products (ATMPs and biologicals). These include, among others, extracellular vesicles (EV) and exosomes of multipotent stromal cells (MSC). [see homepage]

Upstream Technology

  • establishment of scalable technologies for the production of EVs (bioreactor technologies) under GMP conditions
  • validation of immortalized cell lines as a stable starting resource for quality assurance of production
  • manufacture of master and working cell banks to ensure consistent output cells

Downstream Technology

  • establishment and validation of a GMP compliant production train via tangential flow filtration (TFF) and size exclusion chromatography (SEC)
  • development of nanoparticle tracking analysis (NTA / FL-NTA) analysis systems for quality control and product release
  • establishment and validation of analytical methods for the determination of biological and therapeutic potency
  • manufacture of master cell banks and working cell banks from primary and immortalized cells
  • studies to optimize the inoculum for the use of bioreactors
  • GMP compliant equipment qualification and process validation
  • manufacturing and quality control of MSC-EV
  • purification and characterization of EVs from human platelet lysate (HPL)
Mario Gimona

Univ.-Doz. Dr. Mario Gimona

+43 662 2420 80700 mario.gimona@pmu.ac.at

EV-TT Project Head PMU (as Consortium Leader)
Paracelsus Medical University - Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS)
Transfer Center for Extracellular Vesicles - Theralytic Technologies

Eva Rohde

Univ.-Prof. Dr. Eva Rohde

e.rohde@salk.at

EV-TT Deputy Project Head PMU
Paracelsus Medical University - Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS)
Transfer Center for Extracellular Vesicles - Theralytic Technologies

Roman Gangl, MIB

Dr. Roman Gangl, MIB

+ 43 699 144 200 66 roman.gangl@pmu.ac.at

EV-TT Project & Transfer Manager
Paracelsus Medical University - Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS)
Transfer Center for Extracellular Vesicles - Theralytic Technologies

Han Fang

Dr. Han Fang

+43 662 2420 80701 han.fang@pmu.ac.at

EV-TT Scientific Project Employee
Paracelsus Medical University - Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS)
Transfer Center for Extracellular Vesicles - Theralytic Technologies

Claudia Arzt, MSc

Claudia Arzt, MSc

+43 662 2420 80701 claudia.arzt@pmu.ac.at

EV-TT Scientific Project Employee
Paracelsus Medical University - Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS)
Transfer Center for Extracellular Vesicles - Theralytic Technologies

Eva Grasmann, MSc

Eva Grasmann, MSc

+43 662 2420 80701 eva.grasmann@pmu.ac.at

EV-TT Scientific Project Employee
Paracelsus Medical University - Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS)
Transfer Center for Extracellular Vesicles - Theralytic Technologies