We are happy to announce our partnership with RoosterBio Inc. (Frederick, MD) for our first pipeline, SBI-102. This partnership cooperates to start clinical sample production of ShiftBio's first driving pipeline for rare diseases and cancer.
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.
RoosterBio accelerates human mesenchymal stem/stromal cell (hMSC) and exosome product and process development to fuel the rapid commercialization of scalable regenerative cures. Our high-quality hMSCs, bioprocess media, genetic engineering tools, and exosome production solutions are paired with expert bioprocessing knowledge to progress therapeutic developers from concept to first-in-human testing and commercial manufacturing at reduced cost and increased productivity. With optimized, scalable processes, type II drug master files, and cGMP products, we have enabled therapy developers to traverse their path to clinical translation in under 1 year. RoosterBio is driven by client's success and creating a world where safe and effective regenerative medicines are rapidly developed and widely available on a global scale.