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SCALABLE END-TO-END EXOSOME MANUFACTURING
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Extracellular vesicles (EVs) from mesenchymal stromal/stem cells (MSCs) are an emerging class of biologics with wide-ranging potential for a variety of treatments and applications. Yet key challenges remain in harmonizing upstream production, downstream processing, and analytical characterization to produce consistent products worthy of clinical and commercial use. Read on for insights into these three facets of the MSC-EV process.
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MSC-EVs are rapidly gaining momentum in clinical trials globally. One of the challenges faced in EV production is scaling up manufacturing processes to ensure that supply can meet growing demands. That’s why RoosterBio has developed a reproducible and scalable microcarrier-based process for EV production in a stirred tank bioreactor system.
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A chemically defined, fed-batch bioreactor medium can streamline and scale the production of MSC-derived EVs. This single-medium approach eliminates the need for separate expansion and collection phases, simplifying the process and reducing end product complexity. Increase EV yields 2-4-fold while preserving key quality attributes across multiple donors and tissue sources.
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As the number of clinical trials increases, EV production scale increases require paired robust, scalable, and cost-effective downstream processes. Process parameters can be tailored for a wide variety of therapeutic exosome programs and allow for maximum exosome recovery while maintaining quality.
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Biological components in conditioned media are a consistent problem during downstream processing of EVs, blocking filters and resulting in significant EV loss at every step. Novel in-process reagent, AgentV™-DSP, prevents these issues and improves particle recovery 10-fold while maintaining critical quality attributes.
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EV production must align with CMC and regulatory standards before it can reach its full potential. This study compares conditioned medium across scalable platforms to optimize EV manufacturing for the clinic.
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To maximize therapeutic potential, EVs need established quality attributes. This webinar explores how analytical tools can assess the impact of production process choices and tissue source on the quality attributes of MSC-derived EVs.
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Process Development Services
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The path to IND approval for cell-based therapies can be challenging and time-consuming with strict regulatory requirements. RoosterBio has built a robust, scalable, and cost-effective EV manufacturing platform to accelerate every step of tomorrow's exosome-based ideas.
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Download Brochure
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