There is an existential crisis in the cell therapy space as firms face limited and outdated options to track personalized medicines, says supply chain technology developer ATMPS.

ATMPS’ software, Hataali, uses blockchain technology to track cell therapy products from the initial harvesting of cells from a clinical trial participant to the production facility and back through a series of nodes. The software received a US patent for the use of blockchain in personalized medicine earlier this year, and hopes to address some of the challenges that exist in the cell and gene therapy industry.

However, Hataali – which received a US patent for the use of blockchain in personalized medicine earlier this year – is one of a limited number of digital options for cell therapy developers, which remain mostly reliant on paper, legacy tech, or retro-fitting proprietary systems for vein-to-vein tracking of their products, according to Raja Sharif, founder and CEO of ATMPS.

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Speaking to BioProcess Insider, he warned that for advanced therapies including cell therapies, “2023 might be the year the system breaks entirely” if industry does not address digital tracking issues.

“Supply chain and ability to scale are now at critical point, and the industry’s increased dependency on paper is potentially the straw that breaks the camel’s back. We cannot scale with paper safely. This is a well know fact, which many in the industry do recognize.”

(For example, Ori Biotech, which last year teamed with ATMPS to incorporate the Hataali system in its cell and gene therapy manufacturing platform, has been vocal in the restrictions that a non-digital approach has to scaling-up cell therapy production.)

Lack of options

Specific cell therapy software options are few. Along with ATMP’s Hataali, there are some options available from rivals such as Trakcel and Vineti. Meanwhile non-industry supply chain management systems such as interactive response technologies (IRTs) or blood tracking systems are available for, though Sharif said these were not designed for cell therapies.

“The only other option is creating a bespoke platform – but without interoperability and limited time available, this very much will make cell and gene therapy scale impossible. In fact, the idea of lots of separate systems or portals for hospitals and clinics to use for the multitude of advanced therapies coming to the market, is the nightmare scenario that will block new therapy entering the market – there are only so many systems healthcare can cope with, and we are already at the critical point. For example, if you have seven cell therapies available, do we really expect clinicians, nurses, and admins to train on seven different systems and have refresher courses on them annually? This is not efficient, will increase costs for healthcare and prevent or delay new therapies coming to market.”

Thus therapy developers are presented with the option of either internally developing their own proprietary software or paying larger management consultancies to help build it from scratch, he continued.

“This delays their product release, increases costs to the therapy developers, and essentially duplicates the R&D that has been invested by the tech system providers over the last decade. Why would you do that, if an off-the-shelf, tested, and operational solution is available? How do you justify that to the management, or indeed, your investors?”

Hataali 2.0

The smart connected modular digital platform offers a plug-and-play approach for cell therapy supply and manufacturing chains, but ATMP is getting ready to launch Hataali 2.0.

“Hataali 2.0 is more user-friendly, with plug and play modules working independently of each other to provide true flexibility to choose of modules as when needed by our customers,” said Sharif.

“Most importantly, we are comfortable with and integrating with competitors – who in many ways, we do not see as direct competitors, as they have limitations, which are complemented by our various Hataali modules.

“Having the blockchain patent and our bespoke code, means we are not an SAP, Oracle or Salesforce based system but a truly tailored, innovative, and future-proof platform that will be around for decades to come. We focus only on advanced therapies, so all our R&D is focused on cell and gene therapies.”