Just received the following response -"This is a totally...

Just received the following response -

"This is a totally different issue thanthat which occurred with PAT-SM6.

With SM6 the problem was that a“validated” production system yielded product that did not meet specification.This was essentially due to the nature of IgM antibodies, which have lowaffinity for their binding partners. This meant that it was challenging to finda chromatography system that consistently separated the antibodies from othercell material.

We don’t have these challenges with DX1,which has much stronger binding attributes that SM6 did. The current problemwas related to an unexpected issue that arose from scale-up from 10L to 500L.These “surprises” are not unusual, and that’s why we do engineering runs. Weunderstand the issue, and know how to deal with it."

Reassuring.