NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

flipper, one of the major manufacturing bottlenecks in the UK, is that every single batch must be checked by the Qualified Person (QP) and have a QP declaration before the final product can be released. Batch records for cell therapy products can be several hundred pages long, so if batch records are paper, it requires the Qualified Person to be on site, and it could take several hours or more per batch for evaluation. Data recorded manually, can sometimes be prone to human error and reported incorrectly, documentation may be missing or stored elsewhere, or signatures may be missing, etc. If there are errors or deviations, it could potentially take days to certify a batch. To make matters worse, there’s a shortage of Qualified Persons in the UK; as of a couple years ago, there were estimated to be less than two dozen QP’s performing certification activities of CGT products in the UK. This bottleneck alone highlights the need for the digitization of the manufacturing process, and it is why Autolomous was founded. A digital manufacturing process, and an electronic batch record are clearly essential for scaling at volume for a commercial cell therapy product.

I think what Linda was alluding to at the ASM, is Autolomous’ digital batch verification technology, known as AutoloMATE Assist, which is the third module from Autolomous’ digital platform AutoloMATE. The AutoloMATE Assist project began in April 2021, and was expected to last 24 months. (doing the math?)

The first two AutoloMATE modules were AutoloMATE-eBMR, which digitizes batch manufacturing records, and AutoloMATE-CLOCK which provides scheduling of all critical manufacturing processes and variables, from scheduling leukapheresis, to final administration of the finished product to the patient.

According to Autolomous, it will be the first first digital batch verification solution available to the market that will be fully integrated with both an electronic batch manufacturing record and also have scheduling capability. It allows everything in the manufacturing process (including the logistics) to be monitored, captured, traced, and logged in realtime, and the data is secured using blockchain ledger technology. So when it comes to the batch verification and final release of the product, each responsible department, Quality Control, Quality Assurance, and Qualified Person, can easily and quickly evaluate each manufacturing record, (even remotely) which vastly streamlines product release. It’s a pretty big deal in my opinion.

https://autolomous.com/autolomate/

I think I posted this Mark Lowdell’s investment pitch before which includes a development timeline for Autolomous going back the several years that Linda was discussing:

https://atmpmanufacture.org/wp-content/uploads/2019/11/autolomous-mark-lowdell.pdf