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Process developers encouraged to consider shipping from the start

By World Courier

Advanced therapy manufacturers should consider how their products will be shipped as early as possible during process development, according to Andrea Zobel, Senior Director, Personalized Supply Chain.

Zobel, who spoke at the Advanced Therapy Conference 2024 in London recently, believes the design of the formulation and even the manufacturing facilities for advanced therapies need to take the logistics of transporting the product into account.

“Decisions about whether to ship fresh or frozen cells, for example, are often made early during clinical trials and commercialization,” she explained. “But often the thinking isn’t to the end [of the process].” Her talk, on misconceptions in cell and gene therapy logistics, gave examples of problems caused when companies decide on a final formulation, such as vials versus infusion bag, before consulting with a shipper. For instance, infusion bags may not fit in large-scale storage or shipping containers, incurring extra costs.

Alternatively, if a company opts for a manufacturing process for fresh cells, but only builds one factory, the customer base for the product is limited to patients within a 24 to 48-hour transport time. “You have no chance of recruiting patients beyond the area around the manufacturing site. You can’t [have] global [reach], only regional,” she explained.

Widening the options

To widen the options, she recommends companies consider fresh versus frozen, storage temperatures, and the use of stabilization early in the development process. They should also consider the benefits of decentralized manufacturing, including whether to site their process to inside a hospital.

Another consideration is around the relationship between storage temperature and shelf life. “People need to think: ‘do I need a shelf life measured in years when I’m due to use the product in days?’” she said, explaining that products with a shorter shelf life can be stabilized at higher temperatures.

A final consideration is the equipment used in manufacturing. According to Zobel, some commonly used all-in-one closed systems for advanced therapy manufacturing can only dispense product in one format such as fresh cells in an infusion bag. “You can’t freeze [the product], so you have to transfer it to another container, and the whole advantage of working [in a closed system] without a clean room is gone,” she continued.

To help the manufacturer think about shipping, World Courier is working with Pharmalex, another part of Cencora, to provide consultancy on integrating shipping into setting up CMC processes and stability testing.

Zobel’s talk also covered other misconceptions in gene and cell therapy, including whether genetically modified cells and viruses are considered dangerous goods for transportation, and the availability of long-term storage.

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