Although long overlooked, exosomes have been gaining momentum due to their potential for use as cell-free therapeutics. Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells.
Exosome-related technologies have been developing rapidly in recent years and substantial growth is expected for the market as they get integrated into the fields of liquid biopsy, precision medicine and regenerative medicine. There is also a prolific body of research exploring how exosomes can be leveraged as biomarkers to detect cancer and other emerging disease states without the need for biopsy or invasive procedures.
While exosomes derived from multiple stem cell types are being explored, mesenchymal stem cell (MSC) derived exosomes are best represented within the scientific literature, global patent activity, and clinical literature. Today, a market leader in stem cell exosomes is Kimera Labs, the nation’s leading manufacturer of placental MSC (pMSC) derived exosomes.
Kimera Labs, a Pioneer in the Exosome Field
Founded in 2012 by CEO Dr. Duncan Ross, Kimera Labs made history when it launched the first publicly available isolated exosome product. Located in South Florida, the company manufactures state-of-the-art exosomes and other biologic products for the physician and research community. Kimera® also operates the only FDA audited exosome process and maintains a 27,000 square foot GMP laboratory.
Thus far, the company’s first publicly available isolated exosome product has been used in the treatment of an astounding 45,000 patients across a variety of investigational uses.
With the COVID pandemic still underway nationwide, it is timely to note that exosomes have been referenced in numerous scientific and medical publications to exhibit anti-inflammatory properties, including published articles on their investigational use for the treatment of Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19 infection. Based on its strict donor screening practices, ultra-purification methods, and current Good Manufacturing Practices (cGMPs), Kimera® has taken extensive steps to ensure the quality and purity of its exosome products for these intended IND clinical trials.
Challenges with Exosome Standardization and Characterization
Despite surging interest in the use of exosomes within research and therapeutic applications, one of the major challenges to the field is the standardization and characterization of exosome products. To overcome this bottleneck, exosome pioneer Kimera Labs has announced a revolutionary and relevant method to quantifying and characterizing exosomes, termed the Ross Unit (Ru).
The purpose of the Ross Unit (Ru) it is to standardize the measurement of nanovesicle technology, and thus, enable its widespread use.
As explained by the company, Kimera Labs established the Ru in order to correct a misleading concept spread by the tissue banking industry, which is the correlation of particle counts to exosome concentration. In contrast, the Ru will account for exosomal RNA cargo and protein concentration.
Importantly, the Ross Unit (Ru) will allow for a more accurate measurement of exosome quality, purity, and potency and correlate with a more standardized and reproducible method that can improve outcomes for the medical community. This scientifically valid process was developed by Kimera Labs and is being rolled out this quarter (Q1 2021).
With more than 17,500 scientific papers about exosomes and at least 208 clinical trials registered on ClinicalTrials.gov, this announcement is timely for the industry.
As explained by Duncan Ross Ph.D. and CEO of Kimera Labs:
“When we debuted the Kimera® exosome product XoGlo® in 2014, we expended a significant amount of time and effort simply trying to communicate the concept of pMSC derived paracrine effectors consisting of an invisible nanoparticle suspended in saline. However, it was difficult to correlate the number of vesicles to the potency of a finished product. Rather than explain the intricacies of protein characterization, size exclusion chromatography, and other techniques, Kimera® relied heavily on the visual data obtained from a nanoparticle tracking analyzer (NTA). We never intended this data to be used as an industry standard, or manufacturing release criteria for exosomes. Counting particles by NTA is not a reliable method for exosome quantification to establish or demonstrate clinical efficacy.”
To reiterate this point, Kimera Labs never used data obtained from NTA as its sole method of characterization of its XoGlo® products. This is because these particle visualization devices can detect a bubble or a grain of sand as readily as they can detect an exosome. For this reason, Kimera® introduced the Ru to more accurately quantify and characterize exosomes and create a true industry standard.
The company’s objective is to help the exosome industry create a standardized method to track, and objectively present, this highly important data in a way that clinical and regulatory partners can readily interpret.
Kimera® is currently performing comprehensive evaluations of the Ross Unit (Ru) measurement in its own products, as well as products marketed by other exosome vendors.