Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.
|Articles|February 16, 2022
Thermo Fisher Scientific Unveils New CGT Services
Author(s)BioPharm International Editors
Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution
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Cell and gene therapy (CGT) companies can now use new integrated commercial packaging and distribution services from Thermo Fisher Scientific, the company announced on Feb. 15, 2022. The services are designed to facilitate the transition of cell and gene therapies from clinic to commercial launch for patients across the United States and Europe.
Patheon, a Thermo Fisher Scientific company, 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.
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 European Union.
- 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,” said Chris Armstrong, president, clinical trial services, Thermo Fisher Scientific, in a company press release. “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.”
Source: Thermo Fisher Scientific
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