Replies to post #402860 on NorthWest Biotherapeutics Inc (NWBO)

[H2R]

The March 16th PR agrees with you biosectinvestor

BETHESDA, Md., March 16, 2021 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that development of the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority (“MHRA”).

[...]

All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.

The facility is now in the Performance Qualification (PQ) stage, following completion of the Design Qualification (DQ), Installation Qualification (IQ), and Operations Qualification (OQ) stages. Each of these stages has taken many months of work. In the PQ stage, practice runs are conducted for months and the performance data is collected to show that the operations meet all of the applicable regulatory requirements (sterility, quality control testing, etc.). Those data then form a major part of the application to MHRA for certification of the first phase of the facility.

https://nwbio.com/northwest-biotherapeutics-announces-development-completed-for-initial-production-capacity-of-sawston-uk-facility/

NWBO's Sawston facility will get the certification. Advent is the contractor. Looks straightforward.

Thanks biosectinvestor.

Best of luck with Patients, NWBO, and Longs!