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StemBioSys seeks to streamline their CELLvo matrix manufacturing process in order to decrease the cost of production. The main objectives of this project are to design, build, and test a system that StemBioSys can utilize to complete the decellularization process more quickly, with greater efficiency, and with lower production costs. The following report covers the features of our complete design and its three subsystems that combine to accomplish the individual tasks of the decellularization process. The primary functions of the three subsystems are as follows: the flask organizer holds 6 flasks together throughout the process, the guide positions the flask organizer at the desired angle for aspiration steps, and the liquid network dispenses reagents into the flasks for the washing steps. Following the design overview is an evaluation of the final design through the scope of project requirements and constraints, as well as the associated tests used in assessing the overall system's performance.

The design constraints of sterility, maintaining the integrity of the CELLvo Matrix, remaining within the provided budget, and the available space for the final process were all satisfied through our design solution. The sterility constraint is satisfied with the use of one of the recommended materials in Section 2.6. The integrity of the CELLvo Matrix was confirmed by checking that the matrix was not scratched or damaged during the aspiration or dispensing steps. Our final design was able to complete multiple runs of the decellularization process in a biosafety cabinet (BSC) without any damage to the subsystems or flasks, thus meeting the design constraint for the available space. Our budget was to remain under $1,200, and the AvENGRs spent roughly a total of $223 to satisfy this constraint.

Our final design is held to many project requirements that will be detailed in the following sections. The requirement that our solution is to be optimized for Tl50 cell culture flasks is met through the three subsystems' abilities to specifically fit T150 flasks. The liquid network subsystem is able to satisfy the requirement of effectively washing away all detergent without damaging the matrices, which contributes to the production of a uniform project. Additionally, the liquid network has multiple frames and bases that allow for the device to be versatile and portable. Moreover, the flask organizer and guide subsystems are designed so they can easily be reproduced and sterilized, and the quantity produced can be scaled to accommodate the various sizes of manufacturing runs. Since our final solution did not alter the foundation of the decellularization process, we maintain the assumption that our subsystems are capable of producing a uniform product, can be integrated into the current process, can be easily adopted by staff and are compatible with OSHA codes and prevailing industry standards. In addition, the process must be performed in a biosafety cabinet and should be able to accommodate any other processes conducted simultaneously, which were both satisfied during prototype testing. Lastly, the implementation of our three subsystems decreases the total time required to complete the decellularization process, satisfying this requirement. Our overall project requirement to reduce Full-Time Equivalents (FTEs) was also satisfied, as a reduction in time decreases the necessary time for one person to work.

Overall, the AvENGRs have created a successful, working prototype to streamline the· CELLvo matrix manufacturing process. Since all of our requirements and constraints were met, there are no changes needed to achieve remaining goals, but there is always room for the improvement of our working prototype. As a result of the COVID-19 pandemic, the project remains unfinished in terms of producing several polished copies of each subsystem. Therefore, the AvENGRs have provided manufacturing recommendations should StemBioSys choose to further the development of our solution (Section 2.6 and Appendix 5.4).


Team Advisor: Dr. Travis Black

ENGR 4382