NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

ex, I think you are correct that Linda has said that the process is about 7 or 8 days. From what I understand, for autologous therapy manufacture, each patient’s own cells constitute one batch, and if the process is open, then manufacturing requires dedicated equipment and separate cleanroom processing suites to separate each patient-specific product. Each batch must be segregated to prevent cross contamination, and a high-grade cleanroom is required, typically grade B. I think Linda has talked about this slow, manual process and “men in space suits” that was used for the trial. I doubt very seriously this method will be used for commercial production however. Implementing isolators dedicated to one product or patient and/or using automated closed systems alongside single-use fluid paths would allow the processes to be fully enclosed. That approach reduces surrounding cleanroom classification to grade C. Several vendors provide fully automated and closed systems suitable for cell therapy applications. Two of these companies are Terumo BCT and FloDesign Sonics, who signed collaboration agreements with Cognate last fall.