Phoenestra GmbH
Scalable technology platforms for stem cell-derived products

Phoenestra, an agile biotechnology firm focused on regenerative medicine, excels in creating scalable technology platforms for cell-derived products. The firm’s primary mission is to transform the way these potentially game-changing therapeutic modalities are produced. “Our primary goal is to provide an end-to-end approach for generating a broad range of efficacious, high-quality and sustainable stem cell-derived products,” says Klaus Graumann, CEO and co-founder of Phoenestra.

A key area where the company demonstrates exceptional expertise is stem cell generation and expansion, specialising in induced pluripotent stem cell (iPSC) lines and stable mesenchymal stromal cell (MSC) lines. The firm uses urine samples collected from selected donors with all legal and regulatory documentation in place. Next, a virus-free stem cell generation process free from animal-derived components is applied. Selected iPS cell clones are banked and expanded in controlled bioreactor runs. These stem cells are then used for differentiation into tissue cells or for generation of vesicle products such as natural exosomes or nanovesicles.

Collaborating with Evercyte, its parent company enables Phoenestra to obtain stable, telomerised MSC lines which are fully documented. These cell lines are generated in a virus-free manner and without oncogenes to avoid patient and regulatory risks from the beginning. The main advantage of these MSC/ TERT lines is that they can be banked to supply a whole product lifecycle with the same cell line, avoiding risks which e.g., donor variability brings into the game in Regenerative Medicine.

On the processing side, Phoenestra has developed scalable cultivation setups which excel other systems in process performance and control and – most importantly – in exosome productivity.

Exosome quantities needed for supplying clinical studies can be produced at a small scale and within a short time. All the process steps mentioned are designed in a scalable way and are serum- as well as animal-component-free.

Analytical excellence is another key pillar for Phoenestra´s development approach for highly complex products. Standard quality control methods are complemented with a range of orthogonal characterization methods for cells and vesicles which are partly executed in-house, partly with a network of partner companies and institutions. Functional in vitro bioassays to understand e.g., anti-inflammatory and anti-fibrotic properties of product intermediates play a central role here and, in addition, Phoenestra’s partnership with TAmiRNA facilitates the analysis of RNA profiles in cells or exosomes, confirming the cells’ physiological status or important elements of biological activity for vesicles. The firm regards thorough analytical characterization in addition to systematic process development as prerequisites for preclinical and clinical success.

Our primary goal is to provide an end-to-end approach for generating a broad range of efficacious, high-quality and sustainable stem cell-derived products

Moving into the future, Phoenestra is in pursuit to render the therapeutic application of iPS cells even more prevalent with a targeted cell engineering project. Through this project, it seeks to develop a library of allogeneic cell lines that cover a majority of the population without the need for immunosuppression. This engineering strategy which differs from already published and patented approaches is currently in the proof-of-concept and patent filing stage and – if successful - holds enormous transformative potential.

More near term, GMP manufacturing capabilities are currently being implemented to be able to produce master/working cell banks and clinical study materials. Phoenestra will use these resources - which make the end-to-end approach for stem cell-derived products complete - for its own development projects, development partnerships and pure services.

Phoenestra envisions a tomorrow where accessible, personalised medicine is a reality, providing people around the world with efficacious and affordable medicines they need.