NorthWest Biotherapeutics Inc (NWBO)

[MolBiol]

Companies that change the way they produce a biologic must go through an internal change control process. Does NWBO even have a QA/QC with a change control process in place? When you change something of any significance the FDA will request equivalency data that can include additional trials. This can happen pre- or post approval. The company I worked for made a vaccine. The way the downstream processing was being done for the final product changed quite a lot from the vaccine that went into patients in the trials. We had to show the same levels of purity and impurities. Same potency, same stability. We had to do animal studies and additional safety studies. There were numerous hoops to jump through and this was all during the BLA process. If you make a fundamental change to the drug you will be required to do more trials. For L and Direct the drug is dendritic cells. The process for making the dendritic cells outlined for Direct could be adapted to the L process and it makes a lot of sense that it would be. However, it will be through a change control process and whether or not it could be accomplished without the FDA requesting some trial data is questionable. In general, once you start trials you don't change the process unless you absolutely have too. Once you get approval, then you try to implement changes that improve yields, stability, potency etc.