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DRUG MANUFACTURING

GRAND PRIZE

Special Issue 
· Best Practices Making Perfect
· Millennium's PARIS Illuminates Pathways
· The BRAIN Behind BCM's Clinical Trials
· Solutia Streamlines Route from Lab to Production
· Discovery And Development Participants
· Clinical Trials Participants
· Drug Manufacturing 
· The Technology Behind Best Practices
· Technology Providers
July 15, 2003 | The division of Solutia Pharmaceutical Services dedicated to launching and commercializing active pharmaceutical ingredient (API) products, CarboGen AG, struggled to maintain all the disparate systems of spreadsheets, project-management software, databases, and documents related to API projects. As CarboGen grew, company managers knew they needed an integrated model for API development and manufacturing, one that would streamline scientific, product-quality, and financial processes.

CarboGen selected the Axapta software platform from Microsoft Business Solutions on which to build its API Development Project Management system. In a novel use of the technology, the group wrote new functionality into the software so that Axapta project management tools match the way CarboGen project management actually works. For example, a molecule-tracking database was created for all target, intermediate, and raw material molecules. The database was populated not only with textual information such as molecular weight, Chemical Abstracts Service number, safety statements, boiling points, and so on, but also with a molecular drawing (imported from CamSoft's ChemDraw).

This database serves as a source for a synthesis route-management database, where scientists define the reactions of one or multiple routes from raw materials to intermediate molecules to target molecules. Next, the synthesis database forms the base for the project module, where project managers can tie activities to individual reaction steps. A production plan can thus be drafted that contains information concerning project management activities, but is generally organized along the chemical pathway from starting material to final product.

The process of developing and manufacturing a new active pharmaceutical ingredient (API) has historically involved isolated applications, such as individual spreadsheets or small databases, to manage human resources, capital resources, materials, and the other aspects of creating a new compound. Solutia Pharmaceutical Services, under pressure to control these costs, built a single, integrated software application that enables management and control of every resource used in the development and manufacture of API products.

"Solutia's system has two key features that make it exceptional," observes Leon Heredia, district manager, New England, for Stelex-TVG and a judge for the Manufacturing category of Bio·IT World's Best Practices Awards. "First, a simultaneous view of all the components at work in the development of an API product; and second, a cohesive basis for taking the laboratory development process to the pilot-plant level, and from the pilot plant onward to full-scale manufacturing."

Heredia says: "Translating the processes in a development lab and scaling them to commercial manufacturing is one of the hardest things to do in drug making. Solutia's technology smoothes this transition from R&D to production in an extraordinarily efficient and effective way."

— Editors

Special API manufacturing functions were integrated, too, such as lot tracking, control records and reports, and label generation to facilitate compliance with current Good Manufacturing Practices (cGMP), mandated per FDA regulations.

This system has enabled the company to establish and track new production metrics, such as a variance metric for comparing estimates of materials. CarboGen can now decrease the average number of project overruns and better track and control general chemicals used across all production projects. The company has also been able to reduce the total amount of raw material inventory it keeps on hand. Thus CarboGen achieves a real-time, true-cost picture of material usage rather than after-the-fact estimates.

With a fully integrated API development and production system, CarboGen now intends to include analytical information from an off-the-shelf LIMS. That will give users an additional view of projects from an analytical perspective, including specifications and the release of raw materials and final products.

Adapted from company entry 






For reprints and/or copyright permission, please contact  Terry Manning, 781.972.1349 , tmanning@healthtech.com.