NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

antihama, there are three primary processes the Flaskworks’ Eden system must go through before it can be used in the commercial production of DCVax: qualification, validation, and comparability. I believe the first two may have been accomplished based on the ASCO presentation, and they are both necessary to be included in the automated process used for the commercial license application. I’ve posted previously about this here

The comparability study itself (what Dave was discussing) may not have been conducted yet, and Advent may be waiting until the commercial license is approved using the automated process. The Comparability Protocol (CP) takes months to prepare, and it’s usually submitted to the regulator for feedback which could take up to sixty days. The planning and preparation generally take longer than the actual study, which only requires 3 batches for analysis, so there’s still sufficient time to conduct the study, analyze the results, and prepare the documentation before marketing approval is granted and commercialization begins. If the CP is not available when the final marketing application is submitted (and marketing approval given), it can be submitted afterward as a Post Approval Supplement (PAS).

The first inspection may have looked at the IT infrastructure for the facility and immersed systems, such as the control panels for the various processes and systems, the Laboratory Information Management System (LIMS), Document Management System (DMS), Manufacturing Execution System (MES) etc., however, for this commercial inspection, the inspectors would likely be looking more closely at the Process Analytical Technology (PAT), which the FDA defines as, “System for designing, analyzing and controlling manufacturing through timely measurements of critical quality attributes and performance for raw and process materials and processes in order to ensure final product quality.” They are based on the principle that the quality of a product must be from the design. This will include the validation of the automated equipment, which should comply with Good Automatic Manufacturing Practices (GAMP). Most of the automated commercial equipment available from vendors will come with a validation package (including its computer system), however, the Flaskworks’ Eden is a bespoke system which does not, so its validation (including its software/firmware code) will call for closer scrutiny. This (and the software/validation job openings) is what leads me to believe (if there was an issue) there may have been more validation work to do on the Flaskworks system.