NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

flipper, differing opinions can act as a peer review of sorts, and can make this message board a better place. I’ve never claimed to be an expert, and I’m admittedly often wrong in my speculations about Northwest Bio. But in this case, I will maintain that having a leukapheresis date of 12 June, (in my opinion: a manufacturing start date of 13 June), and then availability of the vaccine by the middle to end of July, would still be consistent with using fresh, not frozen leukapheresis material.

As I said, the final release testing of a cell therapy product may not take the full 35 to 40 days as it did almost a decade ago, since some previously manual assays may have been automated over this period, and some of the work (sterility testing) is apparently no longer outsourced, but I’m pretty sure that all of the required tests can not possibly be completed in 30 hours.

Because cell therapy products can’t be sterilized, and the regulators still want to ensure a safe final product, manufacturers are required to conduct the various manufacturing processes in an environment where the conditions are controlled and monitored, and become a part of the manufacturing record. Further, extensive testing of the final product is required, to ensure that it’s not contaminated in any way. While there are more rapid sterility tests nowadays, they are not preferred by the regulators, and I believe they would only be acceptable in the instance that a cell therapy product cannot be frozen, and therefore unable to last until the typical 14-day incubation period has completed before final release. And in that instance, I believe the manufacturer must have further testing available for the patient after administration. I’m not certain, but I also believe that mycoplasma testing, (which takes 28 days) would also be required, since the dendritic cells have a fairly long culturing period.

If you want to post the particular part of the ASM that makes you believe that testing can be accomplished in 30 hours, then I will respond, but otherwise I’m not wasting my time. If I had to guess though, I’d say that it’s actually you who may be confusing Linda’s remarks about “product release testing” with how long it could take for the QP to review all the manufacturing and quality control data, (after all of the final-product testing has been completed) which I’ve also said that the QP review could take up to a few days for a cell therapy product.

Also, if the leukapheresis material is now frozen, are you able to explain:

1.) Why the label in the picture that was posted states that it must be “stored between 20-25C and used within 48 hours“?

2.) Why the patients are required to fly to London for the leukapheresis procedure?