stem cells stable cell lines differentiated cells scalable bioprocessing engineered cell lines extracellular vesicles exosomes nanovesicles

Phoenestra is currently building end-to-end technology platforms to ensure highest technological and quality standards for our products - from donor sampling to released GMP-grade products.

NEW: EVscale^TM - Next Generation EV Manufacturing Platform

Cell lines

Induced Pluripotent Stem Cells (iPSC)

Our patented approach to use cells isolated from urine samples provides a non-invasive source for reprogramming somatic cells to induced pluripotent stem cells (iPSCs) from any healthy individual or specific patient, respectively. Selected iPS clones undergo a rigorous screening and characterization approach. Our iPS research cell banks fulfil all requirements for manufacturing of GMP-grade cell banks.

Mesenchymal Stem/Stromal Cells (MSC)

We are building our MSC technology platform on Evercyte´s industry-leading telomerized MSC lines derived e.g., from Bone Marrow, Adipose Tissue, Umbilical Cord, Wharton´s Jelly, Chorionic Plate or Amniotic Membrane. In contrast to primary MSCs, they maintain their phenotype and consistent growth properties over many generations. Depending on the selected donor and tissue of origin, these MSC lines and their extracellular vesicle preparations display promising biological activities for Regenerative Medicine applications.

Scalable Bioprocessing

The cell and gene therapy (CGT) field is currently still suffering from technological issues and rather low technological maturity levels. Phoenestra is committed to contribute to bridging the existing “industrialization gap” in CGT manufacturing technologies and products. This gap consists of technological pain points and sometimes prohibitive cost of manufacturing (CoM). Phoenestra is developing scalable processes including Control Strategies for cell- and vesicle-based products. The combination of stable, high quality cell lines and scalable bioprocesses with CMC Control Strategies will help bringing much needed products and therapies forward and, ultimately, help providing better access of patients in need to these innovative therapeutic modalities.

Products

Based on our stem cell technology platforms, Phoenestra provides access to a wide variety of promising cell-based product candidates for R&D, drug discovery and therapeutic applications. From the start we have the requirements of the final product in mind.

The selection of donors and donor materials is performed with all safety, ethical and legal requirements in place. For iPS cell-derived products, Phoenestra is currently establishing an end-to-end approach from urine sampling to release of GMP-grade products. For MSC-based products, we provide a one-stop-shop concept in collaboration with Evercyte (stable cell lines, potency assays) and TAmiRNA, the expert company in RNA profiling and biomarker development.

EVscale™ is our world-leading technology platform for manufacturing biologically active EV with consistent quality and in clinically relevant quantities from small manufacturing footprints. With this tech platform, we are the ideal partner for your EV/exosome product development project. Please refer also to the EVscale™ Catalogue in the Resources section.

Interested? Please contact us for more details!

Products available and in preparation:

Xeno-free iPS cell lines
Telomerized MSC (MSC/TERT) lines (GMP-grade, licensed from Evercyte)
Bulk iPS cells and MSC/TERT cells from controlled bioreactor cultivations
EVscale™ Extracellular Vesicle preparations (see EVscale™ Catalogue under Resources)
Engineered “universal” stem cell lines (in development)
iPS cell-derived (pre-)differentiated cells (in development)
Processed cells (in development)

Early pre-clinical data sets suggest combinations of biological activities for EV preparations from MSC/TERT lines with different human tissue background. We are currently strenghtening this database further to prepare for successful translation into human therapeutic products. We are targeting several indications with significant unmet medical need.

Based on available data we are currently focusing on:

Diabetic Wound Treatment (in collaboration with Gipfel Life Sciences GmbH)
Indications in Organ Protection (more to come soon)

Services

Phoenestra offers capabilities and resources also on a fee-for-service basis and dependent on your specific project needs. Please contact us for a discussion on options and opportunities for R&D work or a collaboration regarding GMP manufacturing services. Or simply send us your “Request for Proposal (RfP)”

R&D

Cell line development (xeno-free iPS cell lines)
Cell banking (iPSC, MSC)
Process and product development
Process and product characterization
EVscale^TM - Extracellular Vesicles at scale from different GMP-ready MSC/TERT cell lines at quantities up to 1x10¹³ EV per batch (TFF retentate)
EV from other cell types

GMP (please contact us for timelines)

GMP Cell banking
Pre-clinical and early clinical supplies

Team

Operational Team

Klaus Graumann

CEO and co-founder

Otto Kanzler

CFO, Co-founder of Evercyte, TAmiRNA and Phoenestra

Roland Prielhofer

Bioprocess Engineer

Claudia Lindner

Scientist Cell Biology

Melanie Reininger

Scientist Bioprocessing

Ingrid Hartl

Scientist Cell Biology

Reema Jacob

Doctoral Student

Advisory Board

Regina Grillari, PhD, Assoc. Prof.

CTO Evercyte GmbH, Co-founder of Evercyte, TAmiRNA and Phoenestra

Johannes Grillari, PhD, Assoc. Prof.

Co-founder of Evercyte, TAmiRNA and Phoenestra, Director Ludwig Boltzmann Institute for Experimental and Clinical Traumatology (LBI Trauma, Vienna / Austria)

Heinz Redl, PhD, Univ. Prof.

Entrepreneur and former Director LBI Trauma

Christian Gabriel, M.D.

Physician and Scientist, specialist in Transfusion Medicine, former medical director of the Red Cross Blood Transfusion Center Linz (Austria), part of LBI Trauma