# A Bioreactor for Celullarised Membrane Culture and Delivery under Sterile Conditions

## TL;DR

A new bioreactor was developed to grow cellularized membranes in sterile conditions for tissue engineering.

## Contribution

The novel bioreactor design maintains sterility and prevents membrane shrinkage during cell culture.

## Key findings

- The bioreactor was successfully validated for sterile cultivation of cellularized membranes.
- The design prevents contamination and allows cell adherence and proliferation on membranes.
- It supports safe transportation of cultivated tissue for clinical use.

## Abstract

A novel, user-friendly bioreactor for the cultivation of cellularised membranes for tissue engineering has been successfully designed, manufactured, and validated. This bioreactor features a culture vessel and a cover, the latter equipped with one or more sidewalls to ensure airtightness in two distinct zones, thereby maintaining sterile conditions. The cover, designed to integrate seamlessly with the culture vessel, includes several ports compatible with commercial connectors. This design allows the introduction of cells and culture medium without requiring the opening of the cover, thus preserving sterility. Additionally, the cover is equipped with flanges that effectively press the membrane against the bottom surface of the culture vessel, preventing it from shrinking or shifting. This ensures that cells can properly adhere to the membrane and proliferate. Manufactured under Good Manufacturing Practice (GMP) conditions, the bioreactor supports cultivation in optimal aseptic environments, thereby preventing external contamination. This feature is critical for the safe transportation of cultivated tissue to clinical settings. Validation tests have confirmed the bioreactor’s excellent performance, endorsing its suitability for intended applications in tissue engineering.