RoosterBio, Inc. services

Human Mesenchymal Stem/Stromal Cells (hMSCs) are a heterogeneous cell population derived from a variety of tissue and donor sources. As a raw material in emerging cell, gene, and exosome based therapies, understanding the key quality attributes of your hMSC, such as phenotype, function, and growth kinetics are vital to understanding expansion and therapeutic potential. At RoosterBio Inc., we have years of experience in hMSC isolation, manufacturing, and characterization. Leverage this expertise within your hMSC research by contracting our Analytical Services to asses your hMSC cell populations and accelerate your therapeutic program.

Exosomes / Extracellular Vesicles (EVs) are an emerging class of biologics that play a crucial role in intercellular communication and hold tremendous promise for therapeutic and diagnostic use. A key challenge in the clinical translation of exosome-based therapies is the implementation of robust analytical methods for characterization. The size, heterogeneity, and complex composition of exosomes creates challenges for the use of conventional analytical tools and strategies, especially for critical quality attributes such as purity and potency.

The path to IND approval for cell-based therapies can be challenging and time consuming with strict regulatory requirements. That is why RoosterBio provides Process Development Services to help you build clinical phase appropriate cGMP processes for your specific product needs. We have served many customers to streamline the path to clinical testing with our industry-leading hMSC bioprocess systems. Our solutions will enable your custom manufacturing process to align with regulatory guidance, be scalable to fit future needs, and rapidly turn your product concept into a clinically tested therapeutic.