The collaboration marks a significant milestone for the San Diego-based biotech, as Roswell Park has granted BioSapien access to its GMP Engineering & Cell Manufacturing (GEM) facility in Buffalo, New York. This represents the first time the cancer center has leased cleanroom space to an external organization. BioSapien utilized an ISO-7 environment at the site to complete the production run, while Roswell Park provided essential documentation to support the company's Investigational New Drug submission to the FDA.
In section Releases
BioSapien Secures Manufacturing Partners for MediChip Trials
BioSapien has finalized manufacturing partnerships with Roswell Park Comprehensive Cancer Center and BA Sciences ahead of imminent Phase I clinical trials for its MediChip platform. The company has already successfully produced its first GMP-grade clinical batch, which has been transported to the UAE for upcoming patient studies.
BA Sciences, based in Salem, New Hampshire, serves as the second pillar of this manufacturing pipeline. The firm has validated the GMP analytics required for the clinical product and is currently conducting long-term stability studies to verify the shelf life of the 3D-printed devices. MediChip functions as a slow-release delivery system designed to target the tumor microenvironment directly, aiming to reduce the systemic side effects typically associated with conventional cancer treatments. Following the initial trials in the UAE, which will focus on colorectal cancer, BioSapien plans to evaluate the platform's efficacy for other indications, including lung and pancreatic cancers.
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