A new concept for biopharmaceutical production and resulting regulatory challenges

T. Daszkowski, J. Heidrich, O. Queckenberg
Bayer AG

As part of an industry-academia consortium Bayer developed a demonstrator to showcase production of Biopharmaceuticals in a fully single use, conti/campaign and modular environment. With successful demonstration runs in 2014 Bayer decided to establish a follow up project and to evaluate the reliability and GMP readiness of the highly automated demonstrator.

The talk will first briefly describe the set-up, which includes the equipment, the analytics and how the process is embedded in an overarching process control system including automated sampling for at-line QC-testing.

In the second part we will share results of first test runs of the demonstrator suite and discuss our initial concepts to process understanding and quality control.

In addition, we will outline Bayer’s initial approach how to jointly address open questions with the health authorities.  These questions include aspects of equipment design, definition of CPPs and CQAs, process reliability as well as handling of deviations and operator interaction.