Lack of sample processing capacity in trials sector a challenge for cell therapy firms
COVID-19 showed that while CROs can administer doses, perform leukapheresis and draw blood samples there is a lack of capacity for sample processing, cryopreservation and apheresis.
And this lack of capacity – which is detailed in research published in the journal Cytotherapy – is a challenge for biopharmaceutical firms developing cell therapies according to the research team from US cell processing firm, OrganaBio.
“Following the global COVID-19 pandemic and due to recent advancements of mRNA vaccines, the need for organizations with capabilities to support clinical trials has been increasing. CROs, clinical sites, translational centers and hospitals often have the capabilities to administer doses to participants, perform leukapheresis, and draw blood samples over a period of time.
“However, many of these organizations lack the laboratory infrastructure and staff to support sample processing and cryopreservation of patient apheresis materials, a critical intermediate manufacturing step for many cell-based therapies,” they write.
Partnership
Addressing this short fall will require industry-wide collaboration according to the authors, who cite OrganaBio’s partnership with several biopharmaceutical firms in the greater Miami, Florida and Irvine, California metro regions as an example.
“Team members were trained and qualified by sponsors within four weeks of initial contract execution, and a dedicated project manager works alongside clinical sites to effectively manage timing of sample deliveries and to ensure that the OrganaBio team is prepared to receive and process samples 5 days a week,” they write.
In the first 18 months of the collaboration over 1,200 samples were received and processed – each taking an average of 30 minutes - with a processing success rate of over 99% according to OrganaBio.
The partnership has also created other efficiencies according to the authors, who write that “In addition to cell isolation, OrganaBio cryopreserves and stores study participants’ PBMC samples and retains, allowing for batch shipping to Sponsors, simplifying cold chain management, mitigating risk of loss, and keeping sponsors’ shipping costs down.
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