Since 2013, RoosterBio has been fueling the rapid commercialization of scalable regenerative cures. We provide a solution to the hMSC industry bottleneck by simplifying and standardizing how living cells are purchased, expanded, and used in development.
While product quality is always number one, an overlooked component of bringing a RegMed therapeutic to market is early consideration of final product cost. This includes hidden costs, which can have a major impact on both clinical implementation and commercialization. The goal of this webinar is to discuss the importance of building a strong cost model with a step-by-step MSC-based example and how your model can positively impact your product and process development.
Mesenchymal stromal/stem cells (MSCs) are in the forefront of cell therapies for COVID-19 treatment. However, the COVID-19 pandemic requires rapid deployment of resources that can provide immediate access to MSC-based therapeutics. This webinar will cover challenges and options available for cell therapy product developers in scaling production, including industry best practices that will deliver rapid, safe, and cost-effective solutions to meet the crisis demand.
Extracellular Vesicles from MSCs have been shown to deliver therapeutic effects similar to parent hMSCs, and several clinical trials have been started to date using MSC derived-EV materials manufactured under Good Manufacturing Practices. The main challenges that researchers face when investigating EVs is generating sufficient quantities to explore both characterization and functional studies in applied research and product development. This presentation highlights strategies and systems that radically simplify the production of large quantities of EVs, as well as cGMP raw material requirements for rapid clinical translation.
Extracellular Vesicles (EVs) are a growing segment of Regenerative Medicine and are particularly attractive as a therapeutic model, utilizing a non-viable biologically active agent. In her presentation at ISEV, Taby Ahsan discusses considerations for the manufacturing of EVs derived from mesenchymal stem/stromal cells, including the tissue source, the cell state, and process parameters. She also discusses the importance of evaluating EV productivity in manufacturing processes, highlighting limitations and advantages of 2D and 3D bioreactor production.
The focus of this talk is the scale up of MSC and EV production in bioreactors. RoosterBio is made up of experts in hMSC manufacturing, and we have developed commercially relevant processes in 2D and 3D that enable our customers to develop MSC based therapeutics quickly and efficiently. A couple key highlights include: process scalability for successful commercialization of cell therapy products, higher quantity and quality EV production, and producing EVs with consistent characteristics recommended by ISEV guidelines. Companies should always begin to look at their process with the end goal in mind.
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RoosterBio is proud to announce our next live webinar: Strategic Considerations for Scalable Product and Process Development to Industrialize Your Cell-Manufacturing Supply Chain. In this session we will discuss:
Stay tuned for future updates, as well as other new and improved content.
