RoosterBio, Inc.
RoosterBio, Inc. specializes in simplifying the use of adult human mesenchymal stem/stromal cells (hMSCs) to accelerate the commercialization of therapeutic technologies. The company provides high-quality, scalable solutions for cell therapy, gene therapy, exosomes, tissue engineering, and bioprocessing, enabling researchers and developers to bring innovative therapies to market more efficiently. RoosterBio is committed to making living cells more affordable and accessible, driving the transition of hMSCs from a scarce resource into an abundant one. Established in 2013, RoosterBio aims to fuel the rapid implementation of scalable advanced therapies, ensuring that safe and effective treatments are widely available globally.
Industries
Nr. of Employees
small (1-50)
RoosterBio, Inc.
Frederick, Maryland, United States, North America
Products
hMSC banks (research and cGMP formats)
Human mesenchymal stromal/stem cell vials derived from bone marrow, umbilical cord, or adipose tissue available in research and cGMP-compatible formats with defined vial sizes and donor options for use as starting material.
Cell culture media and bioreactor feeds (research to cGMP)
Chemically defined, xeno-free expansion media, concentrated bioreactor feeds and EV collection media supplied in research and cGMP-compatible formats, available in bottles or closed-system bags and scalable to 3D bioreactor platforms.
Extracellular vesicle (EV) material and preparations
MSC-derived EV preparations and conditioned/clarified/concentrated or purified particle products offered at defined particle counts and processing levels with accompanying analytical release testing for concentration, purity, and marker expression.
Genetic engineering support media (research and cGMP)
Chemically defined, xeno-free media formulated to support viral and non-viral genetic engineering workflows, increasing transduction/transfection efficiency and reducing required vector inputs.
Starter kits and bioreactor setup bundles
Pre-packaged kits combining characterized cell vials with matched expansion media and protocols for rapid donor/tissue screening, starter experiments, and initial bioreactor setup across 2D and 3D workflows.
cGMP-grade cell banks and process media for further manufacturing use
cGMP-produced MSC working cell banks and matched process media provided for use in clinical manufacturing with supporting regulatory documentation and master file references for downstream manufacturers.
hMSC banks (research and cGMP formats)
Human mesenchymal stromal/stem cell vials derived from bone marrow, umbilical cord, or adipose tissue available in research and cGMP-compatible formats with defined vial sizes and donor options for use as starting material.
Cell culture media and bioreactor feeds (research to cGMP)
Chemically defined, xeno-free expansion media, concentrated bioreactor feeds and EV collection media supplied in research and cGMP-compatible formats, available in bottles or closed-system bags and scalable to 3D bioreactor platforms.
Extracellular vesicle (EV) material and preparations
MSC-derived EV preparations and conditioned/clarified/concentrated or purified particle products offered at defined particle counts and processing levels with accompanying analytical release testing for concentration, purity, and marker expression.
Genetic engineering support media (research and cGMP)
Chemically defined, xeno-free media formulated to support viral and non-viral genetic engineering workflows, increasing transduction/transfection efficiency and reducing required vector inputs.
Starter kits and bioreactor setup bundles
Pre-packaged kits combining characterized cell vials with matched expansion media and protocols for rapid donor/tissue screening, starter experiments, and initial bioreactor setup across 2D and 3D workflows.
cGMP-grade cell banks and process media for further manufacturing use
cGMP-produced MSC working cell banks and matched process media provided for use in clinical manufacturing with supporting regulatory documentation and master file references for downstream manufacturers.
Services
Process development and technology transfer
End-to-end upstream and downstream process development, scale-up support, equipment selection, feed strategy optimization, and technology transfer to enable phase-appropriate cGMP processes for cell and EV programs.
Analytical characterization services (hMSC and EV)
Standardized analytical packages for cellular raw materials and EV preparations covering marker analysis, particle size and concentration, protein marker quantitation, nucleic acid identity testing, impurity assays, and optional functional assays to support development and release criteria.
cGMP production, custom manufacturing and fill/finish
Made-to-order cGMP manufacturing and fill/finish services for cell banks and process media with container flexibility and regulatory documentation to support further manufacturing use.
Process development and technology transfer
End-to-end upstream and downstream process development, scale-up support, equipment selection, feed strategy optimization, and technology transfer to enable phase-appropriate cGMP processes for cell and EV programs.
Analytical characterization services (hMSC and EV)
Standardized analytical packages for cellular raw materials and EV preparations covering marker analysis, particle size and concentration, protein marker quantitation, nucleic acid identity testing, impurity assays, and optional functional assays to support development and release criteria.
cGMP production, custom manufacturing and fill/finish
Made-to-order cGMP manufacturing and fill/finish services for cell banks and process media with container flexibility and regulatory documentation to support further manufacturing use.
Expertise Areas
- hMSC manufacturing and banking
- Extracellular vesicle production and downstream purification
- Upstream and downstream bioprocess development for adherent 2D and 3D systems
- cGMP manufacturing and clinical-grade raw material supply
Key Technologies
- 2D adherent multi-layer culture
- 3D fed-batch and perfusion bioreactors
- Microcarrier suspension culture
- Closed-system bagged manufacturing and bulk fill formats