Supply Chain Council of European Union | Scceu.org
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Supply chain integrity the focus of newly launched Thermo Fisher services for CGT sector

The organization notes that a large number of cell and gene therapies are expected to reach commercialization in the next few years. Like with any biologic, the process is the product and it says it wants to lead the charge in helping manufacturers develop quality life-saving therapies.  

Susan Li, director, product management, clinical trials, pharma services, Thermo Fisher, told BioPharma-Reporter the company’s newly launched Patheon commercial packaging and distribution services should help to “seamlessly transition cell and gene therapies from clinic to commercial launch​” for patients across the US and Europe.

“Our integrated services are designed to meet the specialized needs of cell and gene therapies to ensure supply chain integrity from manufacturing through packaging, labelling, and distribution,”​ she said.

The full package, explained Li, combines GMP storage, serialization, ultracold and cryogenic packaging, along with global distribution, which developers need to support their logistics strategies.

“Those [components] complement the company’s fully integrated development and manufacturing capabilities for cell and gene therapies (CGT), which include translational biology, process development and GMP batch manufacturing services to help streamline the path from discovery to clinic across the entire supply chain. This includes cGMP plasmid manufacturing, viral vector services, and cell therapy manufacturing.”

Regulatory-compliant serialization

In launching new therapies, CGT developers require specific validated processes for their commercial logistics strategy from labeling to shipping, stressed Li.

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