CARBOGEN AMCIS offers an integrated platform of services allowing seamless drug substance development from bench to market.

A challenging task, delivering truly integrated drug development services requires the alignment of the whole organization. Typically the sections of the pharmaceutical development pipeline require different skills and cultures. These skills and cultures are major assets, which must remain untouched. In order to allow for a seamless drug development process from bench to market, we meet these challenges by integrating at the level of the working processes and systems.

We integrate along the spine of the drug development pipeline at the following levels:

• Management
• Operations
• Quality
• Sales and Project Management
• Information Technology

Management

A common operational management for CARBOGEN AMCIS is at the basis of the integration.

Operations

By leveraging downstream and upstream knowledge, promoting job rotations, technical staff transfers and ad-hoc formation of joint scientific teams, we have developed CARBOGEN AMCIS into an organization with superior process development capabilities. Our awareness of the conditions and problems that can be encountered in commercial production allows for better anticipation in process research at the early phases of production. As a result, we develop process technology that facilitates late stage and commercial production.

All sites are equipped with multipurpose equipment and with complimentary capabilities and technologies, thereby facilitating further the transfer of processes. The CARBOGEN AMCIS sites are all located in Switzerland at 45 minutes driving distance, which facilitates exchanges and transfers.

Quality

A common Quality Management for all CARBOGEN AMCIS sites ensures harmonized quality systems throughout our organization. The levels of GMP are adapted to the activities performed at each site, with a development focus for early phase supply at Aarau and Neuland and full cGMP focus for commercial production at Bubendorf.

A Global Quality Agreement covers all phases of development.

Sales and Project Management

Our integration offers a unified resource to the customer with a blended team of one sales and one project management individual per customer. Each team member has full responsibility and accountability for the business process and the management of the project. The communication between the technical staff is organized and streamlined to ensure efficient project progress

IT

Our information technology backbone allows CARBOGEN AMCIS employees to securely collaborate and exchange key project data. Project management is supported by Entreprise Resource Planning (ERP) systems specifically customized for early stage development at Aarau and Neualdn and for production at Bubendorf. A fully integrated Laboratory Information Management System (LIMS) manages the large volume of analytical data necessary to support the early development projects.

Integration of the Information Technology systems is ensured by a single IT organization across all sites with common server hardware, software and application standards, common application portfolio and a common intranet platform.