Thermo Fisher's New cGMP-Compatible Cell and Gene Therapy...

Pharma Tech Outlook: Pharma Tech Magazine

Thermo Fisher's New cGMP-Compatible Cell and Gene Therapy Manufacturing is Here

Pharma Tech Outlook | Friday, July 24, 2020

Cell and Gene Therapy Manufacturing can now be compliant with cGMP.

FREMONT, CA: Thermo Fisher Scientific, a pharma solution company, launches an industry-leading product, compliance, and services portfolio that conforms with current Good Manufacturing Practice (cGMP). The portfolio suite is developed with a mission of initiating and coping up with the manufacturing of clinical and commercial cell and gene therapy.

The Thermo Scientific Cell Therapy Systems (CTS) Series Laboratory Equipment is designed as a premier solution that is a comprehensive key to rationalize and optimize the processes involved with cGMP, such as the installation of equipment and its validation process. The manufacturing initiative includes a range of laboratory equipment that is used in cell and gene therapy manufacturing. CTS toolset also caters to biological safety cabinets, centrifuges, CO2 incubators, cold storage systems a multitude of such needs.

The individual products in the Cell Therapy laboratory equipment include quality assurance features such as a documentation package for passing a factory acceptance test. This package contains a set of operating certificates, performance specifications, user guides, and technical manuals as well. The new portfolio is specially made for ensuring compliance, and hence, it is consolidated with the highest level of quality field compliance services, namely IQ, OQ, and others.

Cell and gene therapy manufacturers are increasingly pressurized to come up with innovative, effective, and result-driven life-saving therapies. Also, a multitude of challenges accompanied by the complexity of manufacturing, compliance, and more bring the company's gene therapy manufacturing that is compliant with current Good Manufacturing Practice to the forefront.

Thermo Fisher Scientific Inc. is a global leader in providing pharma-science services, making the world healthier, cleaner and safer being the mission line of the company, Thermo fisher focuses on exploring and redefining the paradigm of life sciences and research, along with devising solutions for analytical challenges faced by the clients. The company also places itself on the lines of improving the quality and precision of patient diagnostics and therapies.

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