rkawong, the company has not announced whether Advent’s commercial license included Flaskworks or not, so we can only speculate about it. Flaskworks’ Eden is a pretty big deal, and if it was included in the commercial license, I would think that it would have been announced. Right? Since it wasn’t, my post was about the reasons why Eden might not have been included in the commercial license. If it wasn’t completely qualified and validated, then I don’t think it would have been included, which is why I don’t think it was.
The Flaskworks system was originally designed and commercially sold as a clinical device (to be used for clinical trials). The GMP regulations for this type of investigational product only requires that the final product be tested to meet the pre-defined final-release specifications. However, to produce a commercial product, the GMP regulations require in-process controls and the ability to test, monitor, and maintain the quality of the product throughout each manufacturing process, to ensure a consistent and high quality final product.
Therefore, in order to be used in the commercial manufacturing process, the Flaskworks system had to be modified and enhanced with a way to monitor and maintain, or adjust the conditions during the culture process. This is accomplished with the use of biosensors which measure and analyze the critical conditions in a culture vessel. They provide real-time, in-process quality control data on measures like cell count, cell viability, cell size, acidity, dissolved oxygen, temperature, and level of metabolites and nutrients. Based on this continual feedback information, adjustment can be made to the different culturing parameters to maintain the optimum culturing conditions to induce differentiation of the patient's monocytes into dendritic cells.
This is just one of the many tasks the Flaskworks' team/Advent has been working on for the past couple of years in order to get the Flaskworks system ready for the comparability studies (along with the qualification of the system and process validation) to prove that it can produce a similar product as the manual method. As far as I can tell, this wasn’t accomplished prior to the filing of the application for the commercial manufacturing license.
