NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Flipper44,

Perhaps you can find here one more indication of using a closed system in Germany: GMP Cell and Gene Therapy-IZI Fraunhofer- Eguipment- CliniMACS Prodigy®:

"The Department of GMP Cell and Gene Therapy operates Fraunhofer IZI's three modern GMP facilities consisting of ten separate clean room suites (altogether 21 clean room grade B manufacturing rooms) which have been specially optimized for manufacturing of cell and gene therapy products, so called Advanced Therapy Medicinal Products – ATMP. The particular specialty of the about 90 highly qualified staff members is the GMP-compliant manufacturing and quality control of investigational medicinal products. GMP-compliant process and quality control development as well as the creation of Standard Operating Procedures (SOPs) are intensively discussed with the project partner before being implemented. The leading staff in charge has many years of experience in designing GMP-processes in the cell therapy area."

https://www.izi.fraunhofer.de/en/departments/leipzig-location/gmp-cell-and-gene-therapy.html#tabpanel-1

Equipment:

Class A (100), B (100), C (10,000), and D (100,000) pharmaceutical clean rooms with a total area of about 1000 sqm, modular structure, divided into suites with separate air filtration. We offer altogether 21 class B manufacturing rooms within three separate clean room facilities for handling different kinds of manufacturing projects for cell and gene therapy products. If required the rooms can be operated according to gene technology safety level S2.
• Qualified equipment for the production of cell-based medicinal products, e.g. particle-monitored class II laminar flow workbenches, CO2-incubators (some with oxygen regulation), refrigerated centrifuges, inverse microscopes, controlled rate freezers for the cryopreservation of cells, storage tanks for storing cells in the vapor phase of liquid nitrogen, CliniMACS®-cell separation system, CliniMACS Prodigy®, LOVO-Cell Processing System, Sepax S-100-cell separation system, ELUTRA® cell separation system, gentleMACS™ Dissociator for tissue dissociation, TSCD II Sterile Tubing Welder, CR6 Tube sealers, etc.)
• Qualified equipment for the quality control of cell-based medicinal products (e.g. Cytomics™ FC500 MPL, FC500 Navios and MACSQuant® flow cytometer, LightCycler realtime-PCR-Cycler, Tecan Sunrise ELISA-Reader, Vi-CELL™ device for the automatic determination of cell count and viability, Sysmex XS-800i haematology system)
• Qualified equipment for sterility testing (BacT/Alert® 3 D Dual T-microbial detection system, Equinox-pump, overpressure isolator within clean room class C) and testing for bacterial endotoxins (Endosafe®-PTS™)
https://www.izi.fraunhofer.de/en/departments/leipzig-location/gmp-cell-and-gene-therapy.html#tabpanel-3

More about CliniMACS Prodigy®:

The CliniMACS Prodigy® is a closed and automated platform with the capability to manufacture various cell types on a single device and within a single process setup. It delivers consistent product quality in every batch enabling reproducible cell production.
The closed system eliminates open processing steps and unnecessary operator transfers between multiple devices. Thereby, the contamination risk and associated quality variation from human intervention is significantly reduced.
https://www.miltenyibiotec.com/BE-en/products/cell-manufacturing-platform/clinimacs-prodigy.html

Regulatory notes:

CliniMACS® Products
The CliniMACS System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans, the national legislation and regulations - e.g. for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved; all other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.

https://www.miltenyibiotec.com/BE-en/regulatory-notes.html