RoosterBio’s MSC-derived exosome bioprocess technology platform enables accelerated development of ShiftBio’s lead therapeutic candidate via a scalable cGMP manufacturing process in bioreactors, downstream purification, and analytical characterization
ShiftBio, a leader in the development of innovative exosome platform technologies, announced today a strategic partnership with RoosterBio, a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services. This partnership will accelerate ShiftBio’s therapeutic candidates, starting with SBI-102 (Stem cell-derived exosomes expressing a therapeutic ligand), into the clinic.
Through this partnership, RoosterBio will develop a cGMP manufacturing process designed to meet the needs for Phase I/II clinical trials, with the ability to scale as needed for Phase III and commercial production. RoosterBio will design and execute all process development studies, leveraging its industry-leading cell and media product portfolio. The manufacturing process will feature genetic engineering of MSCs to express the therapeutic ligand, expansion of stable pools, production of gene-modified exosomes in stirred-tank bioreactors at an initial scale of 50-200L, downstream purification to achieve desired quality attributes, and finally formulation and filling of the drug product. The resulting product will be extensively characterized via state-of-the-art analytical methods to ensure identity, purity, potency, and safety of the engineered SBI-102 exosomes. These processes are built on RoosterBio’s scalable “off the shelf” cell and media product platforms, which come with strong regulatory support packages, including FDA-approved type II master files.
“We are thrilled to partner with ShiftBio, a global innovator in the field of exosomes, to advance their pipeline of transformative therapeutics, starting with SBI-102,” stated Tim Kelly, CEO of RoosterBio. “This program brings together all of RoosterBio’s unique capabilities: our cGMP MSC banks, proprietary media for genetic engineering, cell expansion, and exosome collection, as well as our deep and broad expertise in bioprocess development services. The opportunity to forge a true collaboration and create this kind of impact to accelerate advanced therapies to patients is what drives our entire organization.”
ShiftBio created the Maxisome platform technology that maximizes the expression of therapeutic proteins on the exosome surface, enhancing the overall therapeutic impact, as demonstrated in SBI-102. Their exosome platform technologies also include InProDel and Fusosome, which can make “undruggable” therapeutic macromolecules “druggable.” Based on their innovative platform technologies, nine pipelines will offer a “second chance” to patients without treatment options. ShiftBio strives to solve unmet medical needs with their platform technology-based exosome medicines.
“We have established a novel platform technology for exosome modifications that can address rare diseases and cancers. Especially, our lead candidate SBI-102 shows promising applications in untreatable disease indications. Finding an appropriate partner with expertise that can convert our knowledge into processes and products suitable for clinical trials was one of our company’s most important early decisions. RoosterBio has a proven track record coupled with the right products and processes to move our programs forward. Leveraging RoosterBio’s process development services will enable us to save significant time and expense. As a result of the partnership, we have already made substantial progress towards our first IND,” stated Gi-hoon Nam, Co-Founder of ShiftBio.
Source – PRWeb