Orgenesis and Johns Hopkins University will build a cell and gene therapy processing facility in Maryland, US for point of care treatment.
The 7,000 square-foot POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing, has been partly funded by a $5 million grant from the State of Maryland with building expected to start in Q2 2022 and the facility anticipated to be operational by Q2 2023.
“Orgenesis is a pioneer of decentralized processing and production of CGTs, this particular expansion in the USA will enable our low-cost POCare model to fully deploy in Maryland; bringing us closer to our goal of making CGTs available, accessible, and affordable for all,†a spokesperson for Orgenesis told BioProcess Insider.
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The facility has been designed to meet US Food and Drug Administration (FDA) standards and aims to provide Johns Hopkins’s clinicians and researched with a streamlined route to treat patients and deliver treatments from the lab to trials.
Through streamlining the process, both companies claim it will provide local capacity for processing clinical therapeutics at the PoC, instead of outsourcing clinical trial CGT manufacturing to various third parties.
Additionally, the facility is said to enable fast scale up of additional processing capacity through connecting Orgenesis Mobile Processing Units and Labs (OMPULs), which decrease the implementation time of capacity from 18-24 months to 3-6 months.
The first OMPUL at the Maryland facility is expected to deploy during the second half of 2022 and Orgenesis plans to base thirty of its own employees at the site once completed.
The firm said Maryland has a large talent pool to find qualified candidates and has experienced training people with no prior CGT experience.
“Last year we established an ‘acting’ POCare Center within the Johns Hopkins campus in East Baltimore, in JHTV’s FastForward facility. The employees for the larger facility will be identified in the same way, through local outreach and recruitment.â€
Orgenesis and the US research University first teamed up in February 2020 where Johns Hopkins University licensed access to Orgenesis’s PoC platform which – as the name suggests – is used to develop and process cell therapies in the clinic.
“Orgenesis is a pioneer of decentralized processing and production of CGTs, this particular expansion in the USA will enable our low-cost POCare model to fully deploy in Maryland; bringing us closer to our goal of making CGTs available, accessible, and affordable for all,†the spokesperson said.