Thermo Fisher Scientific Unveils New CGT Services

Cell and gene therapy (CGT) companies can now use new integrated commercial packaging and distribution services from Thermo Fisher Scientific, a contract development and manufacturing organization (CDMO).

Biotech brand Patheon—which is owned by the CDMO—is offering commercial packaging services for CGT as an end-to-end solution that combines the good manufacturing practice (GMP) storage, serialization, ultracold and cryogenic packaging, and global distribution that developers need to support their logistics plans.

Essentially, it is designed to transition therapies from clinic to commercial launch for patients across the US and Europe in a simple manner.

Some priorities surrounding the new services include:

• Regulatory-compliant serialization: Support for the Drug Supply Chain and Security Act (DSCSA) and Falsified Medicines Directive (FMD) designed to ensure that product identity required for allogeneic products is maintained throughout the entire supply chain.
• Global infrastructure: Packaging and distribution services available at cryocenters in Frederick, MD, and Weil-am-Rhein, Germany, support commercial launches in the US and EU.
• Clinical to commercial scalability: Experienced project teams with expertise in clinical trials designed to enable commercial success.

“There is a large number of cell and gene therapies reaching commercialization in the next few years that will make a significant impact in patients’ lives,” says Chris Armstrong, president, clinical trial services, Thermo Fisher Scientific. “Our integrated services are specifically designed to meet specialized needs for cell and gene therapies to ensure supply chain integrity from manufacturing through packaging, labeling and distribution. This will help accelerate the introduction of these important life-saving medicines.”