The objective of Aglaris was to transform the Facer 1.0 to an optimized industrialized equipment (Facer 2.0) and to validate it. To do so, the specific aims were: (1) to manufacture some Aglaris Facer 2.0 units, (2) to verify and calibrate them, (3) to industrialize the single-use cartridge, and (4) to externally validate the technology through a beta-testing program. During the project, the final engineering of the Facer 2.0 has been completed. Aglaris has defined a manufacturing and verification plan for the units that has concluded with the verified units ready for beta-testing. In parallel, the single-use cartridge specific for T cells, where the actual cell expansion takes place, has been also industrialized providing a prototype nearly ready for commercialization. Not only the technical aspects have been taken into account, but also the industrial design has been carefully studied to create a solution that really meets the needs of the end users and provides competitive advantages to other bioreactors in the market.
Regarding the software, a new user interface has been created to improve the user experience with the platform. It has been designed with the feedback obtained from key opinion leaders to ensure its correct use and maximise its functionality. The FACER´s interface provides a step-by-step guide through the process of installation for the user to follow when setting up the single-use cartridge. The user must login in the platform at different stages to allow traceability and follow the on-screen steps in order to correctly place the cartridge in the oven module. The different routines for the culture have been adapted to make them flexible and allow the Facer to work with different cell cultures.
Aglaris has advanced in the regulatory path and it is maintaining and improving its QMS with the intention to be closer to ISO9001 certification. We have created additional documentation required for the certified QMS, such as general documents (scope, objectives) and SOPs.
Due to the recent Brexit, we had to evaluate the effect of the new UK regulation on our products. During the project, we have been preparing documentation for the CE marking (and now also UKCA marking). The requirements have been taken into account when manufacturing both products. The cartridge, which is in contact with the therapeutic product, needs to meet additional biocompatibility and safety requirements. As part of the cartridge industrialization, each component has been carefully selected and internally tested, when required. Furthermore, the sterilization strategy has been defined and tested. Finally, Aglaris has a very strong position on IP, as it has 5 patents already filed on the Facer system.
During the project, Aglaris has been re-evaluating the way the distribution of the Facer will be conducted. Additionally, Aglaris has been planning the ramp-up phase, considering the resources required in terms of personnel, investment, manufacturing, etc.
We have done an extensive dissemination of the Aglaris Facer project within major stakeholders: distributors and end users (point of care, CMO, biopharmaceutical companies). When relationships have been already established, Aglaris has made private demonstrations of the technology either on-site or remotely during the pandemic.
