Information Exchange and Shared Technology Development

The goal of the five Global Skill Centers in research is to strengthen communication and cooperation in areas of strategic importance for delivering the quality drugs of the future. They focus on alternative lead identification, compound pool optimisation, functional genomics, high throughput cloning and expression and human monoclonal antibody.

The compound pool optimisation GSC teams in Ridgefield and Biberach focus on enhancing the quality of the Boehringer Ingelheim compound pool with emphasis on diversity-based libraries as well as targeted libraries for preferred protein classes. A strong emphasis on computational approaches to design compound libraries will be supplemented by the generation of large proprietary virtual libraries and tool sets for computer-based identification of new leads.

The goal of the two teams, one in Ridgefield and one in Biberach is to identify novel lead series, typically in projects where conventional methods have proved unsuitable.

In this Biberach-based GSC, a bioinformatics team and a gene expression modulation technology team are integrated. The two main tasks are to evaluate and disseminate emerging technologies for gene/protein knock-down in vivo and acquiring and propagating siRNA libraries for screening in cell cultures for target identification and/or elucidation of compound action.

This Ridgefield-based GSC will generate in a semi-automated, iterative fashion constructs encoding multiple variants of proteins and perform small-scale expression tests and protein purification.

Key tasks of this Vienna-based GSC is to contribute to the establishment of a new biological entity (NBE) portfolio of research projects to provide fully humanised antibodies and the identification of fully human therapeutic antibodies to target molecules involved in human diseases.

Development at Boehringer Ingelheim operates as one global integrated organisation with two major centers in Biberach (Germany) and Ridgefield (USA) supported by smaller sites in Argentina and Japan. However, for certain functions, where economies of scale are expected through concentration of activities and assets, centralisation in skill centres has become part of Boehringer Ingelheim's strategy. Five Global Skill Centers (GSCs) have been established in development to date.

The Late Stage Drug Product Development Skill Center in Biberach (Germany) is a key element of Boehringer Ingelheim's new strategy for non-clinical development. This center ensures a concentration of technical know-how, better utilisation of assets and a productivity gain through converging processes. Further success factors of this strategy are only one late state drug product development process and one interface to operations.

The Drug Delivery Skill Center in Ingelheim (Germany) encompasses all activities associated with the development of inhalation devices for compounds stemming from all research sites worldwide. At this Global Skill Center, all technical expertise has been established that is necessary to develop new products including the transfer to the relevant manufacturing site.

The Parenterals Development Skill Center in Biberach (Germany) conducts the development of parenteral dosage forms for BI new molecular entities and provides clinical trial supplies for parenteral administration. It provides state-of-the-art technical facilities, expert scientific and technical staff and knowledge as well as a state-of-the-art GMP-compliant sterile manufacturing facility. 

The Highly Potent Compound Facility in Biberach (Germany) is responsible for chemical synthesis of highly potent active pharmaceutical ingredients (APIs; exposure levels <10 �g/m� air) using specialized technical facilities, equipment, staff and expertise (incl. isolation, milling and filling). Technical facilities are based on a house-in-house building concept and apply isolator technologies in most process steps. This ensures highly potent compound manufacture in compliance with applicable workers safety, environmental protection and cGMP regulations.

The Global Clinical Trial Supplies Unit CTSU runs two sites in Biberach (Germany) and Ridgefield (USA). It provides a single international resource for coordination, packaging and labelling of clinical trial supplies.