Delivery of two Bioreactors

Beskrivelse fra ordregiveren

The department of Immunology wish to purchase two bioractors with the following specifications: 1. CE-Marking: The bioreactor must comply with EU regulations and obtain a Declaration of conformity to CE to indicate its conformity with health, safety, and environmental protection standards. 2. IT Interfacing: The bioreactor must be equipped with IT interfacing capabilities to enable data collection, analysis, and process control. This may include connectivity to a software system for real-time monitoring and control. 3. In-Process Monitoring of Culture Conditions: The bioreactor must have integrated sensors to monitor and control critical culture parameters; at least temperature, pH, dissolved oxygen. And preferably the option include more parameters such as (inline) nutrient sensors. The monitoring system must allow for real-time data access and alarms for out-of-range conditions. 4. Scalability During Culture: The design of the bioreactor must facilitate continuous volume expandable scalability, allowing for easy scale-up or scale-out of the cell culture process (not based on successively using bioreactors of increasing size). Especially the bioreactor must allow the initiation of the cell culture process with a relatively small amount of starting material (e.g. such as cell isolated directly from a biopsy). 5. Direct Sampling During Culture: The bioreactor must incorporate a sampling port or system that allows for direct and sterile sampling of the cell culture without disrupting the process integrity. This feature enables the analysis of cell culture parameters and product quality during the culture period. 6. Expansion Under GMP-Compliant Conditions: The bioreactor must enable the expansion of adherent cells under Good Manufacturing Practice (GMP) compliant conditions, ensuring the maintenance of quality and safety standards throughout the cell expansion process. 7. Viability and Purity of Resulting Cellular Products: The bioreactor must be designed to optimize cell viability and purity of the resulting cellular products. This must involve features such as controlled cell detachment mechanisms, gentle agitation methods (preferably lack of headspace, provides a low-shear environment), and provisions for downstream processing integration to maintain product quality. 8. Harvesting of Cells Using GMP-Compliant Procedures: The bioreactor must support GMP-compliant cell harvesting procedures, which must include the implementation of automated, closed-system cell harvesting techniques to maintain sterility, and product integrity. 9. Flexibility in application: The bioreactor must support the cultivation of multiple cell types to ensure it can accommodate future developments in the field. It ideally allows cultivation of both adherent cells (e.g. MSCs) and suspension cells (such as T cells and hematopoietic stem cells) as well as organoids. 10. Single-use culture bags: To minimize risk of contamination and reduce cost/effort for cleaning and sterilization, cells must be cultured in single-use bags with minimal installation requirements.

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