Rentschler Manufacturing Facility Wins 2012 Facility of the Year Award in Equipment Innovation
The Facility of the Year Award (FOYA), sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX and Pharmaceutical Processing magazine, is the premiere global awards program 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.
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) system, 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.
"Rentschler is honored to receive this prestigious award for expanding its manufacturing facility," said Thomas Siklosi, Senior Vice President GMP Operations at Rentschler Biotechnologie. "With this award-winning facility, we can offer our clients substantial cost benefits for custom manufacturing of biologics for clinical trials. In addition, the know-how we gained during the expansion project together with our multiple engineering and equipment partnerships will enable us to cost efficiently design and also build dedicated production facilities for market supplies."
Rentschler's new manufacturing facility consists of four independent, fully configurable multi- purpose clean room suites to be used with different processes as well as one inoculum suite. The standard configuration is designed for the simultaneous operation of two 1,000 L fed-batch processes. Additional equipment for scale-up (e.g. 2 x 1,000 L or 2,000 L) or alternative processes (e.g. perfusion) can be added. The modular concept allows fast implementation of alternative production equipment according to the customers' requirements.
Rentschler Biotechnologie GmbH
Rentschler Biotechnologie GmbH is a global full-service contract manufacturer with more than 35 years of experience in the development, production and approval of biopharmaceuticals in compliance with international GMP standards (EMA/FDA). Rentschler Biotechnologie has nine GMP suites with volumes of 30, 50, 250, 500, 1,000 and 2,500 liters, allowing the production of material for clinical trials (phase I to III) and for market supply. Rentschler also provides regulatory advice, protein analytics, quality control, and the sterile filling of syringes and injection vials. The company is family-owned and independent and has currently about 650 employees.