GE Healthcare Life Sciences says it has completed its first real-world trial of the logistics features of its automation software, Chronicle, with a cell therapy developer.
Orbsen Therapeutics, a company developing a purified stromal cell immunotherapy (ORBCEL), has finished their first pilot studies using Chronicle. The company, founded in 2011, is using the software to monitor their cryopreserved product as it moves to clinical trial and storage sites as part of a large UK collaboration.
“Accurately recording and tracking ORBCEL temperatures from cryopreservation to thawing at the clinical sites is imperative for patient care and regulatory compliance,” explains Stephen Elliman, PhD, Orbsen’s founder and CSO.
Cell and gene therapies are expensive and complex to manufacture, as they consist of living cells that must be accurately monitored to maintain product efficacy and viability. Orbsen was keen to track their product as it moved from the company’s R&D facility in Galway, Ireland.
“We can track the chain of custody,” explains Elliman. “We can track stability, temperature, and whether the shipment has been opened and closed.”
Orbsen is part of a UK-funded collaboration– the Advanced Therapies Treatment Centres (ATTCs) – which aims to develop the logistical infrastructure to deliver complex cell and gene therapies across the UK’s National Health Service. As part of the ATTC network, they will be testing ORBCEL in the POLARISE Phase II clinical trial in autoimmune patients with Crohn’s, lupus and rheumatoid arthritis.
They have successfully completed their first pilot studies shipping products to secondary storage sites and five NHS POLARISE sites, and have another study planned for the New Year.
Prior to digitising their manufacturing records, the company used email and Excel spreadsheets for tracking the shipping and custody of four to five products per month. “Being able to digitise our data in a way that’s GAMP5, 21 CFR Part 11 and EU Annex 11 compliant has really helped us move forwards,” Elliman says.
The company is currently working on several Phase I/II clinical trials, including the NEPHSTROM Phase IIa trial for diabetic kidney disease, the Merlin Phase IIa trial for autoimmune liver disease, and the REALIST trial in patients with acute respiratory distress syndrome (ARDS).
“We’re looking forward to implementing Chronicle when the POLARISE study opens next spring. Having Chronicle implemented into our logistics will permit efficient initiation, conduct and completion of this and future commercialisation studies,” notes Elliman.