Manufacturing & Supply
Industrial scale clean-room manufacturing.
XO-Cargo™ is produced at the world’s first facility purpose-built for industrial-scale milk exosome manufacturing — a dedicated 20,000 sq ft clean-room in Roanoke, Virginia. Every batch is produced to the same specification, from a single auditable US source, under the same controlled conditions. Lyophilized powder format. No cold chain. More than 30 months ambient stability.
The Facility
Not all manufacturing environments
are created equal.
A clean room is a controlled manufacturing environment in which airborne particles, temperature, humidity and pressure are all tightly regulated to prevent contamination. Entry requires full personal protective equipment — gowning, gloves, face covering and shoe covers. Air is continuously filtered and maintained at positive pressure, meaning air flows outward rather than inward, preventing external contaminants from entering.
XO-Cargo™ is produced in a clean room facility built and operated to the highest standards. Every surface, every process, and every piece of equipment is designed to maintain product integrity from first step to final package.
- Location 621 Fugate Road, Roanoke, Virginia
- Size 20,000 sq ft
- Standard Clean-room
- Commissioned 2026 (FDA clearance scheduled: May 2026).
Four stations.
One controlled process.
Every batch of XO-Cargo™ follows the same validated manufacturing process — from raw milk reception through to freeze-dried powder, ready for formulation.
Raw Materials Reception
Milk Pre-Processing
Filtration
Freeze Drying & Quality Control
Quality Control
Every batch.
The same specification.
No exceptions.
Quality control is conducted independently from manufacturing — a deliberate separation that ensures objective batch assessment before any product is released. Every batch of XO-Cargo™ is tested and characterized against a defined release specification before it leaves the facility.
Batch Testing Includes:
- Identity and concentration Confirmation that the batch contains exosomes at the specified particle concentration (5.0 x 10₁₃ exosomes per gram).
- Particle size distribution Nanoparticle tracking analysis to confirm exosome size profile is within specification.
- Purity Assessment of protein and biological content to confirm the absence of contaminating material.
- Microbiological testing Confirmation that the finished product is free from microbial contamination.
- Stability testing Ongoing stability programme confirming more than 30 months shelf life at ambient temperature. No cold chain required.
Record Keeping
Full batch records are maintained for every production run — raw material certificates, process parameters, in-process checks, and final QC results. Complete documentation is available to customers on request as part of the supply package.
Attestations & Certifications
Every batch of XO-Cargo™ is accompanied by the following attestations as standard:
Additional certifications available on request.
Safety & Documentation
Sourced responsibly.
Documented completely.
XO-Cargo™ exosomes are derived from food-grade bovine milk — a GRAS (Generally Recognized as Safe) source. Sustainably sourced from local, pasture-raised dairy streams. Lactose-free. No animal testing. No chemical solvents. No cold chain required.
Full regulatory and safety documentation is available for every product in the XO-Cargo™ range, including safety data sheet, certificate of analysis, certificate of origin, animal testing free statement, and technical specification.
Note for customers with milk allergies:
XO-Cargo™ is lactose-free. It does contain trace bovine milk proteins and is not suitable for use in products intended for people with bovine milk protein allergies.
Supply
The same specification at every scale.
XO-Cargo™ exosomes are supplied as a free-flowing lyophilized powder, available in formats designed for clinic use and commercial formulation. All formats share the same specification, batch documentation, and more than 30 months ambient stability. No cold chain. No refrigerated shipping. No warehousing complexity.
For Clinics
XO-Cargo™ clinic-use milk exosomes are supplied lyophilized in individually filled, sterilized vials. They ship with an Activation Serum, which is added to the vial to disperse the exosomes for use — ready for single-treatment and multi-use clinical applications. Available in boxes of 12.
For Brands & OEMs
XO-Cargo™ is supplied in foil pack format for commercial formulation and production. Sample quantities are available in vials for evaluation and R&D purposes.
Foil Packs
- Pack Size 1g to 1,000g
- Contents 5.0 × 10¹³ exosomes/g
- Suitable For Commercial formulation and production
Samples
Samples of XO-Cargo™ ME and XO-Cargo™ AA are available to qualified brands, OEMs, formulators, clinics and distributors on request (FOC). Each sample is supplied with a full technical specification, certificate of analysis and application guide. Our team is available to support your evaluation.
