NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

flipper, it’s general knowledge in the industry. But a while back I did post a document from the EMA intended to clarify guidance around the comparability issue, which confirms what I’m saying. Some of the new “manufacturing experts” on the board may also benefit from reading it:

Comparability considerations for Advanced Therapy Medicinal Products (ATMP)

Q12: What is the comparability exercise needed when a new manufacturing site is added to an existing authorisation?
A: When several manufacturing sites are introduced under the same authorisation procedure, a high degree of comparability is expected to be demonstrated. The comparability of the product manufactured at different sites should be comprehensively substantiated. The first step should be to perform a comparability assessment of the manufacturing process and equivalence of the analytical methods on both sites by evaluation of process parameters and in-process control, to validate the process transfer. Secondly, the comparability of the product itself through release and suitable characterisation testing should be demonstrated. (See also Questions 4, 6 and 9)

https://www.ema.europa.eu/en/documents/other/questions-answers-comparability-considerations-advanced-therapy-medicinal-products-atmp_en.pdf

See Also:

ICH Topic Q5E
Comparability of Biotechnological/Biological Products
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-e-comparability-biotechnological/biological-products-step-5_en.pdf


FDA Q5E
Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
https://www.fda.gov/media/71489/download