On April 27, 2022 ShiftBio reported its partnership with RoosterBio Inc. (Frederick, MD) for its first pipeline, SBI-102 (Press release, ShiftBio, APR 27, 2022, View Source;bmode=view&idx=11285502&t=board [SID1234629019]). This partnership cooperates to start clinical sample production of ShiftBio’s first driving pipeline for rare diseases and cancer.
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RoosterBio is a leading supplier of human mesenchymal stem cells (h-MSCs) not only with broad knowledge and expertise in bioprocess development services but also with their success in producing cell and media products with FDA-approved type II master files. Through this partnership, RoosterBio and ShiftBio will comprehensively carry out all the process optimization required to produce exosomes expressing a therapeutic ligand at a scalable GMP level by minimizing the risk with bilateral confirmation tests and utilizing their ability to fulfill the current regulation criteria at a very high level.
This strategic collaboration of the knowledge, expertise, and experience aimed to overcome existing know-how limitations of such a recently emerged drug modality in commercial production. ShiftBio applies the regulatory-supported latest innovations to its process and minimizes the years-long new drug development with its perfectly coordinated production strategy that brings the latest technologies of Asia, Europe, and the U.S together. Working with the aim and motto of giving patients a second chance from the very beginning, ShiftBio plans to reach this goal with the right strategic decisions as soon as possible to not lose another incurable patient.