The fully automated exosome extraction and concentration instrument extracts and concentrates exosomes from various liquids, including urine, saliva, cerebrospinal fluid, blood, tears, cell/bacterial culture medium, milk, cell-membrane extrusion vesicles, ginseng infusion, and others. It fully automatically extracts exosomes in different size-fraction ranges, producing highly concentrated exosomes rapidly and without contamination while greatly reducing operator workload.

(1) In-line, non-contact detection of endotoxins and exosomes

During exosome concentration, the system performs in-line, non-contact detection of endotoxins and exosomes.

(2) Endotoxin removal for controlled batch-to-batch quality

During exosome concentration, endotoxins are removed to maintain consistent exosome quality from batch to batch.

(3) FDA 21 CFR Part 11 compliance for controlled batch-to-batch quality

Each process step uses an electronic signature, assigns accountability to a named operator, provides traceable data, and retains records for 30 years.

(4) Aseptic operation without site-specific environmental constraints

• The work area uses a fully enclosed structural design.
• Two ozone-free UV sterilization lamps are installed. Before operation, press the UV sterilization button; the system runs automatically for 30 minutes and then stops. UV exposure time is configurable.
• A HEPA air-filtration unit maintains the entire workspace in a positive-pressure clean environment equivalent to that of a laminar-flow clean bench. Ambient air and bacteria cannot enter the work area, ensuring that all operations are performed under aseptic conditions.
• Aseptic collection is supported. After exosome extraction and concentration are complete, disconnecting the fitting keeps the collected exosomes isolated from the external environment, allowing them to be transferred from the aseptic workspace to a biosafety cabinet for further processing.

(5) Stable exosome activity

An integrated temperature-control system with three independent chilled vessels maintains a temperature of 1–8 °C throughout exosome extraction and concentration, ensuring stable exosome performance.

(6) Low-shear exosome processing with no impact on morphology

Fluid transfer uses disposable syringes instead of a peristaltic pump, keeping the shear rate below 2,000 s⁻¹. This avoids repeated compression of silicone tubing by a peristaltic pump and reduces deformation of exosomes.

(7) High exosome purity, with experimental results of 90–99%

The dual-path exosome purification function promotes bottom enrichment during concentration. Extraction and concentration take place in the upper section of the three-stage filtration vessel, removing non-target proteins and other impurities for efficient exosome filtration and purification. It also prevents exosomes from repeatedly passing through the filtration unit during concentration, further protecting their morphology.

A buffer-exchange function completely removes components and proteins from the original culture medium and replaces them with clear saline, PBS, or purified water, improving exosome purity and broadening downstream applications.

(8) Fast filtration, high throughput, and long filtration-unit service life

The rotating filtration platform causes the sample fluid in the filtration unit to oscillate and repeatedly rinse particles from the membrane surface. This cleans the membrane, improves filtration efficiency and speed, increases processing capacity, and extends filtration-unit service life.

The rotating filtration platform includes a vent valve and a return valve. The vent valve removes air from the filtration membrane to stabilize pressure and improve filtration, while the return valve regulates pressure inside the filtration unit, protects the filtration unit from damage, and ensures that exosomes are processed at a safe pressure.

A pulsed tangential-flow, constant-pressure filtration mode further rinses the membrane surface, removes particulate residue, increases filtration speed and capacity, and extends filtration-unit life.

(9) Enables a continuous, end-to-end production line

The system can be combined with our large-scale stem-cell culture bioreactor to create a continuous process for large-scale cell-culture harvest and exosome extraction, concentration, purification, and buffer exchange.

(10) Convenient clinical use and data management

• Barcode scanning or manual code entry identifies each product lot. All processing parameters for the lot are recorded and retained for up to 10 years. Data can be copied to a USB drive and exported in Excel format.
• The system can connect to a hospital network and integrate with the hospital management system for data sharing and management.
• Remote software maintenance and upgrades are supported.
• A mobile application (APP)/mini-program enables remote viewing of equipment status, production information, and real-time updates.