What's in the vial
Luxir is a highly pure mesenchymal stromal cell (MSC)-derived exosome preparation delivered as an isotonic sterile saline solution. Each 1.0 mL vial contains approximately 1 trillion microvesicles from a single-donor perinatal MSC source; the finished product is a cell-free vesicle formulation, not a stem cell product. No animal or human serum is used in the manufacturing process.
Exosomes are cell-free lipid-bilayer nanovesicles (30-150 nm) enriched with signaling cargo including microRNAs, growth factors, and membrane proteins, released by parent cells and characterized by NanoSight nanoparticle tracking analysis and dSTORM super-resolution imaging.
Manufactured in a cGMP facility with lot-specific certificate of analysis, HPLC purity confirmation, and RNA quantification per lot.
Characterization
NanoSight NTA · dSTORM · HPLC · RNA quantification
Where practitioners use Luxir
- Topical cosmetic use following microneedling, laser resurfacing, and PRP protocols
- Topical application after aesthetic procedures
- Laboratory research in molecular biology and biochemistry programs
Luxir formats
1.0 mL
1 Trillion Microvesicles
Ref: LXR0101
Pure MSC exosomes in normal saline. Single-vial cosmetic-use exosome product. Cold-chain shipped.
5.0 mL
5 Trillion Microvesicles
Ref: LXR0501
5.0 mL Luxir format for larger surface areas; the 1.0 mL format suits smaller treatment sites. Cold-chain shipped.
How every lot is tested
Each lot of exosome material is documented by a certificate of analysis that covers three stages, from the tissue donor to the finished vial. The tests are listed here; the acceptance criteria and results are shared with verified practices on request.
Donor screening
The placental tissue donor is screened before any cells are banked.
- Microbial testing with strain typing
- HIV-1 and HIV-2, by antibody and nucleic acid testing
- Hepatitis B, by core antibody, surface antigen and nucleic acid testing
- Hepatitis C, by antibody and nucleic acid testing
- HTLV I and II
- Syphilis
- West Nile virus
- Cytomegalovirus
- Risk assessment for Zika, Ebola, malaria, Chagas disease and CJD
Cell bank safety
The master cell bank is tested for contamination and adventitious agents.
- Sterility by membrane filtration
- Mycoplasma
- Adventitious viruses, in vitro on three cell lines and in vivo
- Bovine and porcine agents
- Hepatitis A, B and C
- HIV-1 and HIV-2, and HTLV I and II
- Cytomegalovirus and human herpesviruses
- Parvovirus B19 and papillomavirus
Final vial release
Every lot of finished vials is tested before release.
- Sterility by direct inoculation
- Endotoxin
- Mycoplasma
- Zika virus, JC virus and SARS-CoV-2
- Vesicle particle size
- Particle count per vial
- CD81 identity by Western blot
- Purity by SEC-HPLC
- Total RNA concentration
- Osmolality and pH
- Appearance
A certificate of analysis is issued for every lot and provided on request. Requests are reviewed for NPI-verified practices in the practitioner portal.
Regulatory & handling
Cold-chain shipped frozen. Stored at −20°C long term and 4°C once thawed, per the manufacturer's handling instructions. Supplied for topical aesthetic use by licensed practitioners, as labeled by the manufacturer, and for laboratory and IND-authorized clinical research. Not sold for injection, infusion or any other route into the body, and not intended to diagnose, treat, cure or prevent any disease.
Frequently asked questions
- What distinguishes Luxir from the other Kimera families?
- Luxir is the Kimera flagship: purified MSC exosomes in normal saline, without the additional carriers or higher microvesicle loading that distinguish the other families. Each lot is characterized by NanoSight NTA, dSTORM, HPLC and RNA quantification, and those figures appear on the lot's Certificate of Analysis.
- What documentation ships with an order?
- Every vial carries its lot number, and a Certificate of Analysis is issued for every lot and provided on request. Practices with their own documentation requirements should raise them at account setup so we can confirm what we are able to supply before a first order ships.
- How should this material be handled on arrival?
- Check the temperature indicator included with the shipment before the vials go into storage, and move them to their storage condition promptly. If the indicator reads outside range, contact us before use rather than storing the shipment. Storage and handling conditions follow the manufacturer's handling instructions, which ship with each order.
- Who can open a wholesale account?
- NPI-verified licensed practitioners. Verification happens before pricing is released, and professional licensure is confirmed for the destination state before a first order ships.
- What is the regulatory status of this material?
- No exosome product has been approved by the FDA for administration to humans. Material is supplied for topical aesthetic use in clinics and for medical, molecular biology and biochemistry research applications, and is not a tissue product as defined by FDA guidelines. Whether and how it is used in a given session is the licensed practitioner's decision.
Ready to order Luxir?
NPI-verified wholesale accounts unlock full pricing across every format. Request a quote for any format above or apply for a full wholesale account.