Customer of i+o Consultants Receives ISPE Award
News Apr 18, 2012
i+o Industrieplanung + Organization GmbH & Co. KG (i+o) has announced that the new manufacturing facility of Rentschler Biotechnologie GmbH in Laupheim, Germany, has won the 2012 Facility of the Year Award (FOYA) in the category “Equipment Innovation”.
The award recognizes the project for its flexible, multi-product manufacturing facility designed to minimize manufacturing costs and product cycle times.
PHA, Leiden and PhC PharmaConsult, the Biotech and Pharmaceutical centers of excellence within the i+o company provided design, engineering, and IT implementation services from concept to qualification of the facility.
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 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 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.
“We are really proud that Rentschler receives such a notable award. It shows that our interdisciplinary approach and our deep industry know-how has a positive impact on such future driven projects”, says Ernst Sander, Managing Director of PhC PharmaConsult and Partner at i+o.
“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.
The official award ceremony with take place at the Pharma fair INTERPHEX in NYC (1.- 3. May).
A form of the hallucinogenic party drug ketamine has cleared one of the final hurdles toward clinical use as an antidepressant. During a meeting at the US Food and Drug Administration (FDA) in Silver Spring, Maryland, an independent advisory panel voted 14-2 in favor of recommending a compound known as esketamine for use in treating depression.READ MORE