Manufacturing & Supply

Industrial-scale
clean-room manufacturing

Tiny Cargo milk exosomes are manufactured at a purpose-built facility in Roanoke, Virginia, featuring a dedicated 20,000 sq ft clean-room. Every batch meets the same specification, from a single auditable U.S. source — a lyophilized powder with no cold chain requirement and over 30 months of 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.

Tiny Cargo milk exosomes are 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)

The Manufacturing Process

Four controlled stations, one continuous chain of custody.

Raw Materials Reception

Food-grade A2/A2 bovine skim milk from pasture-raised sources, verified BSE/TSE-free and processed using HTST pasteurization prior to entering the facility.

Milk Pre-Processing

Centrifugal separation isolates the target fraction from raw milk, the first step in concentrating exosome content ahead of purification.

Filtration

A proprietary multi-stage filtration process further purifies the material without the use of chemical solvents at any stage.

Freeze Drying & Quality Control

Lyophilization converts the purified material into a stable powder, followed by UV sterilization and quality control checks prior to release.

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Every batch. The same specification. No exceptions.

Each production run is tested against a fixed release specification before it is cleared to ship. The same panel of tests is applied consistently, regardless of batch size or destination, so every customer receives material that is identical in identity, purity and potency to the last.

Batch Testing Includes

01Identity and concentration (5.0 × 10¹³ exosomes/g)
02Particle size distribution
03Purity
04Microbiological testing
05Stability testing

Record Keeping

Every batch is assigned a unique lot number with full traceability from raw material intake through final release. Certificates of Analysis are retained and made available for every lot Tiny Cargo milk exosomes ships.

Sourced responsibly. Documented completely.

Tiny Cargo milk exosomes are derived from a GRAS (Generally Recognized As Safe) source. The finished material is lactose-free, produced with no animal testing, and manufactured without chemical solvents at any stage of processing. As a shelf-stable lyophilized powder, it requires no cold chain for storage or shipping.

Full documentation is available for every lot, including Certificates of Analysis, Certificates of Origin, and Safety Data Sheets, supporting regulatory review and downstream formulation work.

Allergy Note

Derived from bovine milk. While processed to remove lactose, customers with dairy-related sensitivities should review the full Certificate of Analysis before formulating.

The same specification at every scale.

Tiny Cargo milk exosomes ship as a lyophilized powder, packaged and documented to the same specification whether the order is a research quantity or a production-scale run. Every shipment carries the same Certificate of Analysis, the same particle and purity data, and the same shelf-stable, ambient-temperature handling — no cold chain required.

Industrial-scale
clean-room manufacturing

Not all manufacturing environments
are created equal.