What Are Exosomes?
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OmniGenix Exosomes: The Gold Standard In Regenerative Medicine
Placental MSC Exosomes: Pharmaceutical-Grade, Regeneration, Purity, and Precision
How OmniGenix screens, purifies, and validates MSC exosomes to ensure safe, potent regenerative use. Unpack what real exosome testing looks like—and why it matters so much for patient outcomes.
What Every Practioner Needs to Know About their exosome source
Chooses Science, Not Shortcuts
OmniGenix Lab/Manufacturer 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. OmniGenix Lab/Manufacturer uses much more precise exosome detection modalities such as dSTORM microscopy to ensure the MSC origin and quality of its exosome products.
Strict Screening
Exceeding The Highest Standards
In order to create a safe, isolated, placental MSC line, OmniGenix Lab/Manufacturer 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. OmniGenix Lab/Manufacturer 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 OmniGenix Lab/Manufacturer 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.
Sterile Preparation
Sterile Preparation of Purified MSC Exosomes
At every step of its proprietary MSC exosome production process, OminGenix strives to achieve the highest purity of stem cells, culture media and exosomes.
Using ISO 7 clean rooms and ISO 5 isolation hoods, the OmniGenix Lab/Manufacturer’s quality measures begin before the exosome isolation process begins. Fresh cultures of isolated, neonatal MSCs are initiated regularly using culture medium that contains no animal or human products. Unlike many laboratories that use fetal bovine serum or human serum to more easily culture cells, OmniGenix Labs uses xeno-free chemically defined medium to reduce the potential for any type of contamination. As the MSCs release exosomes into the culture media, this conditioned media is sterile-filtered to remove the cells. After separating the MSC exosomes from the cells, the conditioned media undergoes a proprietary, serial purification process that yields isolated MSC exosomes in scalable quantities.
Precisely Characterized
Defining Exosome Detection Methods
OmniGenix Lab/Manufacturer 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. OmniGenix Lab/Manufacturer uses much more precise exosome detection modalities such as dSTORM microscopy to ensure the MSC origin and quality of its exosome products.
Exosome Identity Assurance
High-Quality, Isolated MSC Exosomes
OmniGenix Lab/Manufacturer’s leads the way in defining the character of exosomes, in order to ensure the purity and consistency of its pharmaceutical-grade exosomes.
Beyond the basic modalities of protein analysis, flow cytomery, RNA sequencing and Nano Tracking Analysis, Kimera Labs uses advanced imaging modalities to define the character of its exosome products for use in development of clinical applications. We have have visualized its pure MSC exosome products with electron microscopy and atomic force microscopy to verify that the particles in solution are exosomes based on their surface morphology. Now, using STORM super resolution microscopy, The lab is able to visualize individual proteins characteristic of MSC exosomes such as CD 9, 63 and 81 on the surface of its exosomes. Not only can this technique accurately count exosomes,
it can directly verify that they are in fact MSC exosomes. Beyond characterizing our exosomes, STORM super resolution microscopy can actually visualize internalization of exosomes into live cells and track their movement within the cell. Our lab uses this advanced imaging technology to verify each batch of its pharmaceutical-grade exosomes for quality and consistency.
Our Facility and Equipment
Optimal-Purity Exosomes for Clinical ResearchNano Tracking Analysis (NTA) and Dynamic Light Scattering (DLS) analysis
NTA and DLS are both techniques utilized in the Research and Development (R&D) and Quality Control (QC) laboratories for the analysis and characterization of nanoparticles in solution. NTA analysis is performed using a Malvern Panalytical NanoSight NS300 instrument, while the DLS analysis is performed using the DynaPro® NanoStar® instrument. Both instruments accurately measure the size distribution and concentration of all types of nanoparticles; however, the DynaPro® NanoStar® can differentiate between particle families, and can also be used for proteins, quantum dots, liposomes, metallic nanoparticles, and other types of particle analysis.
D-Storm Microscope
This state-of-the-art super-resolution microscope can capture images of a single extracellular vesicle (EV) in solution. Both, MSCs used in the manufacturing process as well as exosomes manufactured at our labs, are characterized by different means, and nothing captures better multi-color 3D images at 100x resolution than our ONI super-resolution microscope.
ImageXpress Pico Automated Cell Imaging System
The Pico is a cell imaging system used at our labs for cell characterization, as well as for potency assay testing analysis. Whether running fluorescence imaging or brightfield assays, the automated imager has preconfigured protocols that can be used for the development of cell-based assays, which have proven extremely helpful for R&D studies.
High-Performance Liquid Chromatography (HPLC)
HPLC is a technique used for the characterization of the EVs in solution, as well as to determine the concentration and purity of the product. Precise and accurate characterization of the finished vialed product is performed by Size Exclusion Chromatography (SEC) using our Agilent® 1260 Infinity II HPLCs which are equipped with both Diode Array Detector as well as Fluorescence Detector.
Western Blot Technology
Western Blot technique is used to determine the presence of surface markers commonly found on EVs. As part of the characterization and analysis of each EV-lots manufactured at our labs, identification of these markers (e.g. CD81, DC63) by WB is a routine technique utilized to support the identification and concentration of the product.
Beckman Ultracenterfruge
One of the most commonly used techniques for the isolation, purification, and characterization of different biological products is differential centrifugation. Ultracentrifugation is widely used in the purification and characterization of EVs. In our R&D lab, ultracentrifugation techniques have enabled us to continue improving our processes and methods used for EV analysis and characterization.
Reverse Transcription Polymerase Chain Reaction (RT-PCR)
RT-PCR is one of the most sensitive techniques for the detection, quantitation, and characterization of RNA currently used in laboratories worldwide. RT-PCR is used at our labs to accurately characterize the cargo of our EVs. RT-PCR is used to support the analysis of our potency assays, as well as to effectively and accurately compare the RNA cargo of each lot manufactured at our facility.
RNA Sequencer
Our Illumina NextSeq 1000 System, one of the newest and most advanced sequencing instruments available in the market enables us to accurately determine the exact RNA cargo and concentration in our EV products. Our NextSeq 1000 System allows us to accurately use this technology in the analysis and characterization of EVs, while enabling the development of products that perhaps a few years ago were not even imaginable. When samples are processed in our NextSeq 1000 System, we can accurately determine the exact sequence of each of the cargo RNA, as well as the concentration of each specific RNA family. This further assures that our processes are under control, and the quality of the product is been maintained from lot to lot.
Clean Rooms
At our labs, the entire cGMP manufacturing process (upstream and downstream) is conducted inside our ISO 7 certified cleanrooms, which contain multiple ISO 5 certified Laminar Flow Glovebox Isolators (LFGIs). ISO certification not only ensures compliance with the most rigorous environmental control standards but also helps to reduce the possibility of contaminating the product while being processed. From procedure-driven routine and meticulous aseptic cleaning of the rooms to recurring environmental monitoring, nothing is left to chance when the sterility and quality of the product are at stake. The room as well as the LFGIs are equipped with High Efficiency Particulate Air (HEPA) filter, which traps particles that are 0.3 microns and larger. Multiple UV-C lights in the room, inside the LFGIs, as well as in the AC ducts, are used to further assist in maintaining the sterility of the room.
D-Storm Microscope
This state-of-the-art super-resolution microscope can capture images of a single extracellular vesicle (EV) in solution. Both, MSCs used in the manufacturing process as well as exosomes manufactured at Kimera Labs are characterized by different means, and nothing captures better multi-color 3D images at 100x resolution than our ONI super-resolution microscope.
"Advancing Regeneration, Empowering Healing."
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Why Choose Us?
Expertise
Our exceptional team is comprised of national and international experts renowned for their unparalleled proficiency and knowledge in the realm of regenerative medicine.
Sourcing
The MSCs are obtained from a single placental source, ensuring that the process is ethical and compliant with regulatory standards. This source is preferred because neonatal MSCs are known to have superior regenerative potential compared to adult-derived MSCs.
Compliance
Every batch undergoes comprehensive third-party testing, and we provide a Certificate of Analysis with every order. This ensures absolute transparency, allowing both doctors and patients to verify exosome count, growth factors, proteins, cytokines, and purity—leaving no room for doubt.
Quality Control
Throughout the entire process, OmniGenix implements rigorous quality control measures to ensure the purity, potency, and safety of the exosomes. Advanced characterization techniques are used to confirm the identity and quality of the exosomes before they are released for research or clinical use.
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We would be happy to answer any questions you might have about our MSC exosome products. You may call, email, or schedule a product consultation appointment at your convenience.