NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Exwannabe,

I think that de most important thing is that the FDA requires cell therapy developers to demonstrate that no manufacturing changes affect their product profiles for safety, identity, purity, or potency.

Article:
Factories of the Future Can Patient-Specific Cell Therapies Get There from Here?
Brian Hampson and Jacob Ceccarelli.

Note:patient-specific cell therapies (PSCTs)

CoMparabiliTy risk
When exploring the four drivers of commercial viability — quality, cost, scalability, and sustainability — a PSCT developer must consider the potential comparability risk and anticipate the implications of making changes after or during late-phase clinical trials to address them. As dictated by the US Food and Drug Administration (FDA), cell therapy developers must demonstrate that manufacturing changes do not affect safety, identity, purity, or potency. Depending on the nature of the change and product characterization results, a demonstration of comparability between pre- and postchange product might require only laboratory testing or could require additional clinical studies. Early in a clinical development program, a manufacturing process change does present comparability risk. But much less is at stake at that point than after substantial clinical data have been generated, when establishing comparability would be costly for the developer or even could require repeating a late-phase trial. Some process changes have relatively low comparability risk, whereas others have relatively high risk. For example, changing a critical raw material in a core process step (e.g., transitioning from animal serum to serum-free culture media) would present a major comparability risk. However, the risk associated with switching from manual recordkeeping methods to electronic record-keeping would be minimal. Risks generally are lower when changes do not alter the journey that cells take (Table 2).

http://www.bioprocessintl.com/wp-content/uploads/2016/04/14-4-sup-Hampson.pdf

Article:
Progress Toward Commercial Scale and Efficiency in Cell Therapy Bioprocessing.
by David Orchard-Webb Monday, October 17, 2016

http://www.bioprocessintl.com/manufacturing/cell-therapies/manufacturing-cell-therapies-commercial-scale-efficiency/