Large-Scale Production of Exosome
NextGen Exsome ultilize an in-house separation system for large-volume exosome isolation, employing the widely adopted technology of Tangential Flow Filtration (TFF) combined with Size Exclusion Chromatography (SEC). The system engineered for the large-scale production of exosome, enabling a streamlined process from input to the acquisition of high-purity exosomes, along with comprehensive product quality assessment. The team has not only secured its process development with proprietary intellectual property rights but is also capable of flexibly adjusting the exosome separation and quality control processes to meet varying downstream development needs and industrial-scale systems. The comprehensive processing methodology includes several critical steps, including pre-treatment of the fermentation broth supernatant, coarse filtration using a porous membrane system, fine filtration with a ceramic membrane system, bi-phase disk sterilization filtration, ultra-high pressure tangential flow concentration, low-pressure high-flux size exclusion chromatography purification, iodixanol cushion ultracentrifugation concentration and purification, as well as quality control of exosome purity and contaminants. Additionally, this technology includes processes such as freeze-drying or hydrogel loading and processing, ensuring the efficiency and high-quality standards of the products.
Scale-Up Production
1.Filtration
Employ a multi-stage filtration approach using ceramic membranes and microporous membranes to remove a significant amount of cellular debris and large particulate complexes.
2.Concentration
Utilize a high-pressure tangential flow ultrafiltration system for sample concentration, attaining a 10:1 concentration ratio under aseptic and low-temperature conditions.
3.Purification and Recovery
Implement size exclusion chromatography for exosome separation and subsequent concentration of the clarified post-concentration supernatant, achieving up to 90% purity in separation efficiency.
Workflow
