Science that Shapes the Future
Kimera's Unique MSC-Derived Exosome Platform
Advancing Exosome Science Through Precision and Innovation
The Science of Cellular Communication
Understanding the biology of MSC-derived exosomes begins with the source. Mesenchymal stem cells (MSCs) are found in a variety of tissues throughout the body, and the biological characteristics of those cells influence the composition and molecular cargo of the exosomes they produce.
The tissue of origin plays an important role in shaping the proteins, lipids, messenger RNA (mRNA), microRNA (miRNA), and other bioactive molecules carried within exosomes. As a result, researchers continue to investigate how different MSC sources contribute to the unique biological properties and signaling profiles of their extracellular vesicles.
Placental MSCs obtained from the chorionic plate represent one of the earliest connective tissue progenitor cell populations and are an important focus of exosome research. The placenta’s natural role in supporting fetal development has made it a valuable source for studying the complex mechanisms of cellular communication and the biological cargo contained within MSC-derived exosomes.
Screening
Exceeding The Highest Standards
In order to create a safe, isolated, placental MSC line, Kimera Labs® has implemented a strict screening process that exceeds the standards required for tissue banks and cGMP manufacturers.
Similar to the screening process performed by tissue banks, donors are tested for HIV, HTLV, Hepatitis B, Hepatitis C, Syphilis and CMV. Kimera Labs® goes beyond these FDA requirements by testing for these viruses and additional testing for Zika, EBV, Hepatitis E, HHV6, HHV7, HHV8, HSV1, HTLV1, HTLV2, BKV, and Norovirus. Exosomes produced by Kimera Labs® remain under quarantine prior to release for research use until testing confirms that they are negative for these pathogens.
In addition to understanding the rigorous screening and testing process for pathogens, it is important to note that placental mesenchymal stem cells are not a natural reservoir for these viruses. Any possible risk of contamination of donor tissues despite rigorous screening is furtherer reduced during the MSC culture and exosome isolation process. Finally, sterility and endotoxin assays are performed after the final stage of production to confirm the absence of any infectious agents.
Isolation
Precision Exosome Manufacturing
At every stage of its proprietary MSC-derived exosome manufacturing process, Kimera Labs is committed to precision, quality, and scientific excellence. From donor-derived cell banking to exosome isolation and characterization, every step is performed under rigorous quality standards designed to support consistency, reproducibility, and product integrity.
Operating from its 27,000 sq. ft. manufacturing and research campus in Miramar, Florida, Kimera Labs has implemented an integrated quality management system certified to ISO 9001:2015, ISO 13485:2016, and ISO 22716:2007. Together with ISO Class 7 cleanrooms and ISO Class 5 biological safety cabinets, these standards support a highly controlled manufacturing environment for MSC-derived exosome production.
Kimera utilizes xeno-free, chemically defined culture media containing no animal- or human-derived serum components, minimizing variability while supporting a controlled production process. Following cell culture, conditioned media undergoes sterile filtration and Kimera’s proprietary multi-step isolation and purification process to produce highly characterized MSC-derived exosomes for scientific research and cosmetic innovation.
Characterization
Defining Exosome Detection Methods
Kimera Labs® has pioneered innovative techniques and technologies to more precisely characterize and quantify exosomes for quality assurance and exploration of exosome-based diagnostic modalities.
Generally, exosome characterization has utilized the most widely available types of biologic content assays to define properties such as protein concentrations, and more recently, particle counts. Nano Tracking Analysis (NTA), which uses light scattering from nanoparticles to provide discrete particle quantification and size distribution, is commonly used to validate the concentration of exosomes in research samples. NTA provides an accurate measure of exosomes in a sample only if the sample consists of pure exosomes. Any other nanoparticulate material, such as viruses or antibody-antigen complexes that may be present in a biologic sample, can cause a. falsely elevated assessment of the number of exosomes in that sample.
Because NTA cannot distinguish between nanoparticulate debris and exosomes, other exosome detection modalities are necessary to confirm the nature and number of exosomes in a sample. The substantial error that can occur with counting exosomes along with other nanoparticles in amniotic fluid or processed tissue, such as bone marrow or placental tissue, can not only result in significantly exaggerated counts of the number of exosomes in a sample, but also means that there may be a large amount of nanoparticulate debris remaining. Kimera Labs® uses much more precise exosome detection modalities such as dSTORM microscopy to ensure the MSC origin and quality of its exosome products.
Identification
High-Quality, Isolated MSC Exosomes
At Kimera Labs, characterization is the foundation of quality. Through a comprehensive analytical workflow, every production lot undergoes rigorous evaluation to verify the identity, composition, and consistency of our MSC-derived exosomes.
Our characterization platform combines multiple complementary technologies, including nanoparticle tracking analysis (NTA), flow cytometry, RNA sequencing, proteomic analysis, high-performance liquid chromatography (HPLC), and electron microscopy. Together, these methods provide a comprehensive understanding of exosome size, concentration, molecular cargo, and biological identity.
Kimera Labs further validates its exosome platform using advanced dSTORM (direct Stochastic Optical Reconstruction Microscopy) super-resolution imaging, enabling visualization of individual exosome-associated biomarkers, including CD9, CD63, and CD81. This high-resolution technology provides an additional level of confirmation, supporting the characterization and consistency of every production lot.
By integrating advanced analytical technologies with rigorous quality standards, Kimera Labs continues to advance the scientific understanding of MSC-derived exosomes while setting a benchmark for precision characterization and manufacturing excellence.
Advancements in Exosome Technology
Understanding the molecular composition of exosomes is expanding new opportunities for biomarker discovery and scientific research. Through advanced exosome characterization and analytical technologies, researchers continue to investigate how exosome-associated proteins, lipids, messenger RNA (mRNA), microRNA (miRNA), and other molecular signatures vary across different biological states.
Kimera Labs utilizes a comprehensive suite of characterization technologies—including ELISA, high-performance liquid chromatography (HPLC), RNA sequencing, nanoparticle tracking analysis (NTA), atomic force microscopy (AFM), transmission electron microscopy (TEM), and dSTORM super-resolution microscopy—to advance the scientific understanding of MSC-derived exosomes and their molecular composition.
By combining precision characterization with rigorous scientific investigation, Kimera Labs is helping expand the foundational knowledge of exosome biology and supporting ongoing research into future biomarker discovery and diagnostic innovation.