Partnering with a cell therapy developer, GE Healthcare Life Sciences completed its first-real-world trial of the logistics features of its Chronicle automation software.
Founded in 2011, Orbsen Therapeutics (ORBCEL) selected the Chronicle logistics software. An immunotherapy biotech, they are developing a purified stromal cell immunotherapy. They are using the Chronicle software product to monitor their cryopreserved product as it moves to clinical trial and storage sites as part of large UK collaboration, reported Genetic Engineering and Biotechnology News.
Consisting of living cells that must be accurately monitored to maintain product efficacy and viability, the process of manufacturing cell and gene therapies is incredibly complex and expensive. Orbsen identified the product to help them track their product as it moved from the company’s R&D facility in Galway, Ireland. Stephen Elliman, PhD, Orbsen’s founder and CSO, noted, “Accurately recording and tracking ORBCEL temperatures from cryopreservation to thawing at the clinical sites is imperative for patient care and regulatory compliance.” He continued, “We track the chain of custody,” such as stability, temperature, if the shipment has been opened, etc.
The Advanced Therapies Treatment Centres (ATTCs)
ATTCs are UK-funded initiatives aiming to develop the logistical infrastructure ready for delivery of complex cell and gene therapies across the UK’s National Heath Service (NHS). Orbsen, part of the UK-funded collaborative, aims to test ORBCEL in the POLARISE Phase II clinical trial in autoimmune patients with Crohn’s disease, lupus, and rheumatoid arthritis.
Thus far, the first successful pilots are completed—shipping products to secondary storage sites and five NHS POLARIS sites. Another study is forthcoming in 2020.
Success thus Far
Prior to using this software, ORBCEL used email and Microsoft Excel spreadsheets for tracking the shipping and custody of four to five products per month. This new system supports GAMP5, 21 CFR Part 11 and EU Annex 11 compliance.
The company is working on several Phase I/II clinical trials, such as the NEPHSTROM Phase IIa study for diabetic kidney disease; the Merlin Phase IIa trial for autoimmune liver disease; as well as the REALIST trial centering on patients with respiratory distress syndrome (ARDS).
For more on GE Healthcare Life Science manufacturing software Chronicle, see here.Source: Genetic Engineering and Biotechnology News