February 15, 2011 (Vol. 31, No. 4)

Data-Management and Execution System Will Be Used to Manage Mammallian Cell Culture Data

Lonza selected IDBS to provide an electronic data-management and execution solution for mammalian cell culture process development. Lonza officials said they will use IDBS’ Bioprocess Execution System (BPES) to optimize the management of process development data for Lonza customers.

“We believe that adopting IDBS’ Bioprocess Execution System as our data-management solution will help us improve our processes and enhance the quality of the services we provide to customers,” said Steve Flatman, Ph.D., head of mammalian development services at Lonza.

“We were impressed by a number of factors: the flexibility of the software platform to meet the different needs across both free-form research activities and controlled execution of standard processes; the ability to manage highly heterogeneous data types found in bioscience (rather than chemical reaction centric software platforms, which meet the specific needs of chemists); and the ease of use of the software as well as its being reasonably intuitive for scientists.”

Pharmaceutical companies invest considerable time and money generating high-value data throughout the development life cycle. This information is often locked in paper records or isolated electronic files, across multiple locations and in different formats, making it difficult to manage and analyze process data efficiently.

According to IDBS, its Bioprocess Execution System (BPES) creates a fully electronic development history record that supports processes through the development lifecycle, helping engineers to develop robust, scalable, and transferable bioprocesses. By integrating and optimizing workflows, the system reportedly enables more efficient process execution and reporting.

Custom Manufacturing Processes

Lonza’s mammalian development services business unit develops custom manufacturing processes and delivers other related services for biopharmaceutical products. For this development work, and particularly for work based on Lonza’s platform processes, it is possible to automate many aspects of the data life cycle (i.e., from raw data at the lab bench, through to scientific interpretation), noted Dr. Flatman.

“This opportunity for data automation will certainly improve the reliability, efficiency, and effectiveness of these operations, including reducing the elapsed times of data-management activities.”

Equally important is access to knowledge, pointed out Dr. Flatman.

“By having data indexed to a central database, it is possible to retrieve this data more easily than from stand-alone documents. This will allow a much greater capability to study relationships and trends and consequently a better understanding of the influence of process inputs on the (desirable) outputs of a process. Therefore, overall again increasing the technical standards of Lonza’s development services.”

“IDBS continues to develop informatics solutions that address the critical business needs of high-value R&D and manufacturing activities,” said Neil Kipling, founder and CEO of IDBS.

Data-Management Technology

“BPES is based upon IDBS’ data-management technology,” noted Kipling, adding that it is a solution that can be rapidly deployed to streamline and optimize bioprocess workflows.

“This allows data to be stored in context and more effectively shared between groups, deployed as a source of corporate knowledge, and used to monitor and improve process development and biological production operations,” he said.

According to Kipling, this solution enables organizations to:

• lessen the amount of repeated work by more than 10% with better access to current and past data and knowledge;

• reduce unnecessary load on fixed capital assets;

• speed up development, technology transfer and continuous improvement;

• troubleshoot processes and perform root-cause analysis in minutes rather than weeks;

• implement a knowledge and data management platform to support ICH Q10, QbD, and process understanding;

• compare data and perform process intelligence queries to help improve and optimize processes;

• trace and optimize component usage and equipment performance; and,

• dramatically reduce the time assiciated with technology transfer.

Lonza officials said that it was because of these advantages and capabilities that they chose the IDBS system.

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