The demands on logistics services providers is increasing, as the number of cell and gene therapies currently in clinical development worldwide exceeds 1,000.
Headquartered in Cardiff, UK, TrakCel, a software developing company with a platform dedicated to cell and gene therapies tracking, aims to address the challenges in the booming market, and over the past year recorded revenue growth of 300%.
Outsourcing-pharma spoke with Ravi Nalliah, CEO of TrakCel about how the market has shifted, and how a company in the supply chain can stay on track.
“Cell and gene therapies differ from traditional pharma products and the industry needs to recognize and respond accordingly,” he told us, presenting the example of CAR-T therapies, which require different responses from service providers.
According to Nalliah, in the case of CAR-Ts, logistics providers are “not just taking centrally manufactured products and delivering to clinical trial sites, but taking patient-specific material and moving it to manufacturing sites to manipulate and then return to the same patient.”
“You have a supply cycle, rather than a supply chain. In essence, you are adding an additional arm to the supply chain,” he added.
Furthermore, Nalliah said the market has been reshaped by the need for a patient-specific supply chain for these types of therapies, as “we can be dealing with patients that are critically ill, so for time-dependant treatments the need for optimally scheduling activities becomes crucial.”
The main demand from researchers and developers is for the provider to be able to demonstrate compliance to regulatory authorities, Nalliah added, as the pressure for accelerated clinical development for life-saving and time-dependent treatments rises.
Specifically, developers need to be able to demonstrate that they have managed their supply chain correctly, “for autologous therapies traceability, an immutable record from collection of starting material right through to administration of a therapy is required to prove that each treatment has been manufactured from patient-specific starting material and that there was no cross-contamination in the process.”
According to Nalliah, the pressure rises as the developers try to move into the clinical environment as quickly as possible. “It’s not just about providing tools to allow companies to be compliant, but to provide turnkey solutions so that they can address the regulatory needs from clinical to commercial without redesigning the supply chain,” he said.
Looking to the future, Nalliah estimated than these complex supply chains will eventually reach a level of standardization, as more products gain regulatory approvals.
In addition, Nalliah said that “the efforts of the early entrants to market are likely to establish paradigms for the management of starting material and administration of these therapies.”
“Templates of standardization will provide a springboard for which other products currently in development will adhere,” he added, noting that traceability will remain one of the main challenges for the foreseeable future.