Thermo Fisher Scientific has introduced an end-to-end packaging and distribution service for the cell and gene therapies market, aimed at transitioning therapies from the clinic to commercial launch in Europe and the US.
“Our integrated services are specifically designed to meet specialized needs for cell and gene therapies to ensure supply chain integrity from manufacturing through packaging, labelling and distribution. This will help accelerate the introduction of these important life-saving medicines.”
Patheon commercial packaging services for cell and gene therapies (CGT) combines GMP storage, serialisation, ultracold and cryogenic packaging, as well as global distribution.
“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. “Our integrated services are specifically designed to meet specialised needs for cell and gene therapies to ensure supply chain integrity from manufacturing through packaging, labelling and distribution. This will help accelerate the introduction of these important life-saving medicines.”
The service includes regulatory-compliant serialisation, with support for the drug supply chain and security act (DSCSA) and falsified medicines directive (FMD). It also makes use of Thermo Fisher’s expertise in cold-chain and cryogenic storage, as well as its global distribution capabilities, with an in-house shipper fleet and experience shipping to 5,000 clinical sites.
These services are aimed to complement the company’s integrated development and manufacturing capabilities for cell and gene therapy, 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.