NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

meirluc, the Leukopacks are the white blood cells from healthy donors, which would be used the same as the leukapheresis material from cancer patients in the Flaskworks system for the operational and performance qualifications of the flaskworks system, as well as the comparability study. New equipment, like the Flaskworks system, must be qualified before it can be used in a GMP facility. As a reminder:

During the equipment and facility qualification process, you should establish and provide documentary evidence of the following steps:

Design Qualification (DQ)
The intent of design qualification is to produce evidence that the equipment and the processes have been designed in accordance with the requirements of GMP, which include:
– Generation of user requirement specifications
– Verification that design meets relevant user requirement specifications.
– Supplier assessment /audits
– Challenge of the design by GMP review audits
– Product quality impact assessment
– Specifying validation documentation requirements from equipment suppliers
– Agreement with suppliers on the performance objectives
– Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) & commissioning procedures
– Defining construction and installation documentation to assist with Installation Qualification (IQ).

Installation Qualification (IQ)
The intent of installation qualification is to produce evidence that the equipment has been built and installed in compliance with their design specifications.
Installation qualification will provide you with documented evidence that the equipment or system has been developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and In-house requirements.
Furthermore, installation qualification ensures that a record of the principal features of the equipment or system, as installed, is available and that it is supported by sufficient documentation to enable satisfactory operation, maintenance, and change control to be implemented.

Operational Qualification (OQ)
The intent of operational qualification is to produce evidence that the equipment operates in accordance with the design specifications.
The operational qualification will provide you with documented evidence that the equipment operates as intended throughout the specified design, operational, or approved acceptance range of the equipment, as applicable.
In cases where process steps are tested, a suitable placebo batch will be used to demonstrate equipment functionality.
All new equipment should be fully commissioned prior to commencing operational qualification to ensure that at a minimum the equipment is safe to operate. All mechanical assembly and pre-qualification checks have been completed, the equipment is fully functional and the documentation is complete.

Performance Qualification (PQ)
Performance qualification will provide you with documented evidence that the equipment can consistently achieve and maintain its performance specifications over a prolonged operating period at a defined operating point to produce a product of pre-determined quality.
The performance specification will reference process parameters, in-process, and product specifications.
Performance qualification requires three product batches to meet all acceptance criteria for in-process and product testing. For utility systems, performance qualification requires the utility medium to meet all specifications over a prolonged sampling period.
The performance qualification documentation should reference standard manufacturing procedures and batch records and describe the methodology of sampling and testing to be used.

If the Flaskworks system was qualified for investigational use, (which is not the same as commercial use) and approved by the MHRA for use in that manufacturing process, then Advent could use it for manufacturing DCVax for compassionate use at Sawston. Advent skipped that step, and went straight to developing Flaskworks for commercial use.

So your question is: “Where did all the money earned from 200 or many more patients end up?”

The money wasn’t accounted for on NW Bio’s quarterly report because it never existed, because the supposed “200 compassionate-use patients” never existed. It’s really not complicated. Only a handful of compassionate-use patients are treated each quarter, and the minimal revenue earned, does show up and is accounted for in NW Bio’s quarterly reports. If I remember correctly, it was approximately $2M in total, all of last year.