Kimera® Labs, one of the nation’s top manufacturers of placental MSC (pMSC) derived exosomes, today announced the establishment of a novel and more relevant method to quantify and characterize exosomes – the Ross Unit (Ru), in an effort to standardize the measurement of nanovesicle technology.
Kimera® Labs has established the Ru in order to rectify a misleading concept perpetuated by the tissue banking industry that has correlated particle counts obtained by nano tracking analysis (NTA) to exosome concentration. In a novel approach to the subject, the Ru, accounts solely for exosomal RNA cargo and protein concentration as opposed to gross quantification of all species (excipients) present in a solution. This scientifically valid process was developed by Kimera® Labs Inc. and will be implemented in XoGlo® certificates of analysis in the first quarter of 2021. The Ross Unit (Ru) describes a more accurate measurement of the purity and potency of exosome preparations and provides a reproducible method of therapeutic product characterization that will ultimately translate to improved patient outcomes.
“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,” said Duncan Ross Ph.D. and CEO of Kimera® Labs. “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 produced by nanoparticle tracking analysis (NTA) in order to communicate the exosome concept. We never intended NTA data to be used as an industry standard, or a manufacturing release criteria for exosomes. Particle count by NTA is not a reliable method towards exosome quantification or the establishment of clinical efficacy.”
The XoGlo® product was created and quality controlled according to the measurable physical output of a number of MSC cells over a two day period of in-vitro culture since 2014. Kimera® Labs Inc. has never used data obtained by NTA as a method of qualification of XoGlo® products, as these particle visualization devices can detect a grain of salt, or a bubble, as easily as they can a legitimate exosome (nanovesicle). Because of this discrepancy in nanoparticle analysis, Kimera® has now developed the Ru to better quantify and characterize exosomes and create a true industry standard unit of measure. The company’s objective is to help the nanovesicle industry create a standardized method to present, and objectively quantify, highly important data in a way that clinical partners can reliably interpret and believe.
Kimera® is performing comprehensive evaluations of the Ross Unit measurement in its products for submission to the FDA for our current IND application, while performing an industry wide characterization of products marketed as exosomes.
Source – PRNewswire