Design, engineering, and IT implementation services from concept to qualification of the facility had been provided by PHA, Leiden and PhC PharmaConsult, the Biotech and Pharmaceutical centers of excellence within the consulting and planning company i+o Industrieplanung + Organisation headquarter in Heidelberg, Germany.

The Facility of the Year Award (FOYA) of the International Society for Pharmaceutical Engineering (ISPE) will be officially handed over at the pharmaceutical technology trade show Interphex in New York City, May 1-3, 2012. FOYA is focused on recognizing state-of-the-art projects utilizing new, innovative technologies to reduce the cost of producing high quality medicines and to improve the quality of products.

"This clinical manufacturing facility already paves the way towards the factory of the future for commercial biologics manufacturing," says Dr. Philipp N. Hess, Managing Partner PHA - Philipp Hess Associates and Partner at I+O.

Rentschler's new manufacturing facility in Laupheim, Germany consists of four independent, fully configurable multi- purpose clean room suites to be used with different processes as well as one inoculum suite. The new facility features a flexible space concept comprising independent, connectable all-purpose clean rooms designed for the operation of 100% mobile, single use manufacturing equipment for upstream and downstream processing.

Due to the consistent use of single-use equipment, steam-in-place (SIP) and clean-in-place (CIP) operations are obsolete. All clean room suites include connections to the facility-wide data logging system (DLS), which is preconfigured for plug and play setup of mobile manufacturing equipment. Further optimization was achieved based on lean logistic and manufacturing principles and the consequent implementation of a visual factory concept. The modular concept allows fast implementation of alternative production equipment according to the customers' requirements.

"With this award-winning facility, we can offer our clients substantial cost benefits for custom manufacturing of biologics for clinical trials", said Thomas Siklosi, Senior Vice President GMP Operations at Rentschler Biotechnologie.