Frederick, Maryland, USA and Nottingham, UK – April 26th, 2023 – NanoFCM Co., Ltd today announced that RoosterBio, Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, development services, cell engineering, and advanced therapy bioprocess solutions, is approved to provide analytical services worldwide using NanoFCM’s NanoAnalyzer.
In this strategic partnership, RoosterBio becomes the first US-based service provider approved by NanoFCM to perform contract analytical services using the NanoAnalyzer platform. RoosterBio has leveraged the NanoAnalyzer in its exosome / extracellular vesicle (EV) analytics workflows for over a year and offers this technology as a stand-alone service as well as integrated within broader exosome process development programs.
In recent years, exosomes have emerged as a powerful new therapeutic modality, and the number of EV-based products in preclinical and clinical development is increasing rapidly. Traditional methods for exosome characterization have been limited to population-level analysis, while conventional flow cytometry lacks the sensitivity required for single nanoparticle analysis. NanoFCM’s NanoAnalyzer instrument has become established as a powerful tool for multiparameter characterization of natural and synthetic nanoparticles at the single-particle level. RoosterBio is routinely applying this technology to accelerate its customers’ path to the clinic as part of a comprehensive suite of analytical methods to characterize the quality, identity, purity, and potency of both native and genetically engineered exosome products.
RoosterBio and NanoFCM will leverage their combined expertise to develop updated protocols, procedures, and expanded analytical capabilities for NanoFCM’s NanoAnalyzer instrument.
“The in-depth knowledge and expertise in EV characterization provided by RoosterBio will allow new and existing EV platforms to thrive in this exciting field,” said Ben Peacock, Head of Research for NanoFCM Co., Ltd. “Coupled with innovative technologies like NanoFCM’s NanoAnalyzer these analytical services will drive promising advancement in EV research, therapeutics, and prognostics.”
“We are delighted to be selected as an approved provider for state-of-the-art exosome analytical characterization using NanoFCM’s NanoAnalyzer technology,” said Tim Kelly, Chief Executive Officer of RoosterBio. “Exosomes offer extremely high utility as a new therapeutic modality with the potential to address unmet medical needs, but perhaps the biggest obstacle the field faces is the lack of sensitive, quantitative technologies for EV characterization. Together with NanoFCM, we are solving these key challenges and creating the framework for a truly well-characterized EV biologic.”
RoosterBio accelerates human mesenchymal stem/stromal cell (hMSC) and extracellular vesicle (EV) product and process development to fuel the rapid implementation of scalable advanced therapies. Our high-quality hMSCs, bioprocess media, genetic engineering tools, and EV production solutions are paired with expert bioprocessing knowledge to progress therapeutic developers from concept to first-in-human testing and commercial manufacturing at reduced cost and increased productivity. With optimized, scalable processes, Type 2 Master Files, and cGMP products, we have enabled therapeutic programs to traverse their path to clinical translation in under 1 year. RoosterBio is driven by clients’ success and creating a world where safe and effective regenerative medicines are rapidly developed and widely available on a global scale.
Implementing strategies for single particle quantification and cargo detection, NanoFCM provides a versatile and powerful platform with the NanoAnalyzer, a flow cytometry based system for multi-parameter nanoparticle analyses. Precise measurement of elastically scattered light from single nanoparticles allows for high-resolution size distribution, comparable to cryo-electron microscopy, with fast acquisition times of 1-2 minutes also yielding particle concentration data. Fluorescent labelling technologies can be implemented to yield concurrent detection of important cargos such as proteins, nucleic acids, and lipids. Global implementation at some of the top research institutions and high-tech enterprises continue to demonstrate the benefits of nano-flow cytometry for particle characterization.