Biotech Company Selects Purpose Built LIMS for Manufacturing QA/QC

Thermo Fisher Scientific, Inc., has announced that Cell Genesys, Inc., a California-based company dedicated to developing and commercialising novel biological therapies for patients with cancer, has selected Thermo Scientific Darwin LIMS? v 2.0 to manage its laboratory data. Darwin is the only laboratory information management system (LIMS) available that is built expressly for pharmaceutical manufacturing R&D and QA/QC.

"Cell Genesys selected Darwin as the LIMS to be implemented in our organisation for several reasons," said Charlene Banard, vice president, Quality, at Cell Genesys. "The following factors were instrumental in our decision to select Thermo Fisher over other leading LIMS providers Darwin's ability to meet user requirements in an out-of-the-box solution, thus minimizing customisation and implementation time; its user interface; Thermo Fisher's Quality System and coding practices; the company's longevity and success; and total cost of ownership.

"The implementation of Darwin LIMS is one of the key activities we are undertaking to better enable our organization to develop and commercialise novel biological therapies for patients with cancer," Ms. Banard continued.

Darwin LIMS is designed to support, out-of-the-box, the complex testing, workflow and regulatory requirements in pharmaceutical manufacturing R&D and QA/QC environments. Standard functionality includes dissolution, stability testing, environmental monitoring and product and batch management. This ensures compliance with regulations from the US Food and Drug Administration.

Thermo Fisher Scientific markets Darwin LIMS and other leading laboratory software and related services under the Thermo Scientific brand. Thermo Scientific LIMS and CDS facilitate laboratory data in the world's leading pharmaceutical companies, petrochemical and chemical plants, food and beverage manufacturers, and other major industries. To support our global installations, Thermo Fisher provides implementation, validation, training, maintenance and support from the industry's largest worldwide informatics services network.