New manufacturing facility

Rentschler Biotechnologie is a global full-service contractor with more than 30 years of experience in developing, manufacturing and approvals of biopharmaceuticals. The company's new production facility for monoclonal antibodies has been designed to cater for an annual capacity of up to 10 products with a maximum of 24 1000 litre charges. The target was to achieve high flexibility and lower manufacturing costs.

Project challenges

io-consultants was commissioned as the lead consultant for all project phases from concept design to final qualification. In 2012, the project received the ISPE Facility of the Year Award for Equipment Innovation. A significant feature of the new biotech production facilities is the flexible space concept. It comprises four independent all-purpose cleanrooms for the mobile single-use production equipment required for upstream and downstream processing. For maximum flexibility, all the cleanroom suites are connected to a data monitoring system configured specifically for the plug-and-play mobile production facilities.

This flexible and modular room design means that several products can be produced simultaneously yet independently of each other and enables fast product changes. Utility columns supply the mobile single-use equipment, which is also automatically recognised by the DLS system. These state-of-the-art modular facilities are a shining example of a 'biopharmaceuticals manufacturing plant of the future'. 

Lead consultant for all project phases for new manufacturing facility

Pharma/Biotech planning, Manufacturing IT

Laupheim, Germany

Customer value

The project also comprised the installation of a new IT system. io-consultants was responsible for the planning, supervision and introduction of SAP ECC 6.0, LIMS, EQMS, as well as various Microsoft Project and SharePoint systems. Thanks to the use of state-of-the-art project and change management methods, the venture was completed on schedule.

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Tim Walter Business Unit Manager Phone: +49 (0) 62 21 / 379-111