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.
A highlight of the new services, she said, is regulatory-compliant serialization, which supports the Drug Supply Chain and Security Act (DSCSA) and Falsified Medicines Directive (FMD). That aspect of the portfolio is designed to ensure that product identity required for allogeneic products is maintained throughout the supply chain, she explained.
Shipping to clinical sites
The company can also leverage its deep expertise in commercial cold-chain and cryogenic storage and global distribution, said the Thermo Fisher representative. The company’s in-house shipper fleet enables seamless distribution, and the company has experience shipping to over 5,000 clinical sites worldwide in over 39 countries. “This enables critical therapies to get to the right patient, at the right time, at the right temperature.”
'White glove' courier services for high-value shipments provides complete oversight of supply chain, said Li, while packaging and distribution services available at cryocenters in Frederick, Maryland, and Weil-am-Rhein, Germany, support commercial launches in both the US and EU.
In addition, said Li, the company’s project teams have vast expertise in clinical trials, which can help CGT developers achieve commercial success.
