Thermo Fisher Launches Offering to Facilitate cGMP-Compatible Cell, Gene Therapy Manufacturing

Thermo Fisher Scientific announces the launch of a compliance and services portfolio, compatible with current Good Manufacturing Practice (cGMP) and designed to enable rapid start-up of clinical and commercial cell and gene therapy manufacturing.

Developed as the first-ever all-inclusive solution to simplify and optimize the cGMP equipment installation and validation process, the Thermo Scientific Cell Therapy Systems (CTS) Series Laboratory Equipment are comprised of a comprehensive range of key laboratory equipment routinely used in cell and gene therapy manufacturing, including biological safety cabinets, centrifuges, CO2 incubators and cold storage systems. Each product includes a factory acceptance test documentation package comprised of operating certificates, performance specifications, user guides and technical manuals. The portfolio is also supported by high quality field compliance services, including installation setup, IQ, OQ and other support, such as temperature mapping and calibration.

"Cell and gene therapy manufacturers are under increasing pressure to deliver new life-saving therapies, while challenged with complex manufacturing processes and the associated compliance requirements," said Hugh Tansey, senior director, innovation and growth programs for laboratory equipment at Thermo Fisher Scientific. "In support of cGMP, the CTS Series Laboratory Equipment have been developed to address some of the challenges our customers face every day so they can focus on what matters the most — using science to save patient lives."

The CTS Series Laboratory Equipment are manufactured at ISO13485-certified sites, and designed to meet global mechanical and electrical safety standards. The portfolio is available for sale in more than 150 countries and is supported by an extensive global service network of subject matter specialists.