A GMP facility of the future implemented in the present

Below you will find the slides of the presentation by Andreas Eberle, Vice President and Head of Manufacturing for Co.don AG, and Massimiliano Cesarini, Comecer Global Sales Manager. It was delivered on 11 September 2018 at Phacilitate Leaders Europe, Cell&Gene Therapy Manufacturing Scalability track.

CO.DON AG is a German company specialized in cell cultivation for the regenerative treatment of articular cartilage defects. CO.DON AG  commissioned us to design and manufacture a cleanroom alternative to be deployed in their new human cell production site in Leipzig, Germany. The solution we are building includes 144 FlexyCult™ incubators and much more, making it our biggest installation to date.

What questions did the audience ask in the Q&A session?

How do you manage the inlet of materials inside the isolator during the process?

There are basically 2 ways to do this:

• Your starting material is in a closed container and then it can be sterilized by a short VPHP cycle in a passbox suitably arranged for the scope.
• Your starting material cannot undergo VPHP sterilization: then we reproduce the cascade of hand cleaning you do in a classical environment, by successive cleanings under laminar flow till reaching the level of cleanliness you need. We do that using a suitable pre-chamber and laminar flows.

Did you also integrate the centrifuge and how is it being decontaminated?

Yes. The centrifuge is integrated into the workbench and it is decontaminated during the initial step of the operation, by leaving it open while the whole system is decontaminated by a VPHP cycle.

Was it difficult for Co.don to move to isolator technology? What kind of process re-arrangement did you have to carry out?

We were already using isolators in our current manufacturing therefore what we did was to implement improvement and a few adaptations to host the scalability option given by the Flexycult technology.

You can also watch the 3D video simulation of the new plant.

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