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Safety & quality

Safety, by design.

A manufacturing environment built to the Standards for Biological Raw Materials, culture without animal-derived components, lot-by-lot safety testing, and third-party verification. TechnoCell's safety program is the sum of design choices that prevent incidents. Serious safety incidents since our founding: 0.

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  • 0incidents

    Serious safety incidents (since founding)

  • 100%

    Lots tested before release

  • 8items

    Safety tests and issued documents (secretome)

  • 12items

    Quality tests (β-NMN)

Our commitment — Stem cell secretome

Three Pillars of Safety

Safety for our stem cell secretome rests on three pillars: the manufacturing environment, the culture method, and the specialists who manufacture it.

10,000

Cleanroom cleanliness class

Manufacturing environment

Products are manufactured in Class 100 biosafety cabinets installed inside a Class 10,000 cleanroom, in compliance with the environmental standards recommended for the manufacture of regenerative medicine products.

  • Class 10,000 cleanroom
  • Class 100 biosafety cabinets
  • Compliant with manufacturing standards for regenerative medicine products

0

Animal-derived components and medium-derived proteins

Culture method

Fully xeno-free culture with no animal-derived components. The collection medium is protein-free, containing no medium-derived proteins, and our proprietary medium keeps impurities out from the manufacturing stage onward.

  • Fully xeno-free
  • Fully protein-free
  • Zero impurities through a proprietary medium

10+ years

Research experience at research institutions (all manufacturing staff)

Manufacturing specialists

Every member of our manufacturing staff holds a doctorate in medicine or pharmaceutical sciences, with more than 10 years of research experience at national universities and other research institutions.

  • Doctorates in medicine or pharmaceutical sciences
  • Backgrounds at national universities and research institutions
  • More than 10 years of research experience

Our commitment — β-NMN

Three Principles of Quality Control

β-NMN quality is controlled to a medical grade under three principles: manufacturing in Japan, third-party testing, and a completely additive-free product.

Japan

Place of manufacture (Nihon Sogo Iryo Seiyaku)

Made in Japan, low-temperature process

Manufactured at a facility in Japan under a low-temperature process. Binder-free technology means no binders or excipients are used.

  • Made in Japan (Nihon Sogo Iryo Seiyaku)
  • Quality preserved by a low-temperature process
  • Binder-free technology

Every lot

Third-party Certificate of Analysis issued

Third-party verification

Testing is commissioned to Japan Food Inspection Corporation, a testing laboratory registered with the Ministry of Health, Labour and Welfare (MHLW), and to Japan Food Research Laboratories (JFRL), so results are certified by independent bodies rather than in-house testing alone.

  • Japan Food Inspection Corporation (MHLW-registered laboratory)
  • Japan Food Research Laboratories (JFRL)
  • Certificate of Analysis issued for every lot

99.0%+

Purity specification (measured values stated on the Certificate of Analysis)

Additive-free, pure material

A pure material containing no additives, excipients, or preservatives. Purity is specified at 99.0% or higher (measured value on the Certificate of Analysis: 100.4%). All four heavy metals — arsenic, total mercury, lead, and cadmium — are confirmed below detection limits.

  • Purity 99.0% or higher (specification)
  • All 4 heavy metals not detected
  • Endotoxin below 0.15 EU/mL

Safety testing

Safety Testing by Product

Every product is tested in accordance with the Standards for Biological Raw Materials. Tests are performed on each manufacturing lot, and a Certificate of Analysis is issued.

Stem Cell Secretome

Freeze-driedLiquid-frozen

8 items

Adipose-derived / deciduous tooth pulp-derived / umbilical cord-derived

ItemWhat is verified
Issued documents
SDS (Safety Data Sheet)A safety data sheet covering composition, handling, and emergency measures is issued for every product.
Safety tests
Sterility testingConfirms the product is free of bacteria, fungi, and other microorganisms.
Mycoplasma testingConfirms the absence of mycoplasma, a contamination risk specific to cell cultures.
Endotoxin testingConfirms that pyrogens derived from Gram-negative bacteria (endotoxins) are below the specified limit.
Patch testingSkin safety confirmed by a patch test against a control product (24-hour continuous application).
Viral infection screeningConfirms negative results for HIV-1 / HIV-2 / HBV (hepatitis B) / HCV (hepatitis C) / HTLV-1 and -2 / syphilis / human transmissible spongiform encephalopathy.
Cytokine analysisQuantifies key cytokines including EGF, VEGF, TGF-α/β, and IGF, and confirms that inflammatory cytokines (IL-6, TNF-α) are below the limit of quantification.
Exosome analysisAnalyzes the miRNA content of exosomes to obtain supporting data on composition.

β-NMN

Freeze-driedMade in Japan

12 items

β-nicotinamide mononucleotide

Test item (method)SpecificationResult
Quality and physical properties
Purity (high-performance liquid chromatography)≥99.0%100.4%Measured value on the Certificate of Analysis / Japan Food Inspection Corporation, Report No. 722G040810-001
Appearance (organoleptic testing)White to pale-yellow crystalline powderConforms
Moisture content (infrared heating evaporation method, 105℃ × 25 min)≤1%0.60% (conforms)
pH (pH meter method)3.0–4.5 (1.0g/100mL)Conforms
Bulk density (fixed-volume method, untapped)≥0.6 g/mL0.61 g/mL (conforms)
Microbiology
Coliforms (BGLB method)NegativeConforms (negative)
Total viable count (standard plate count agar method)≤100 CFU/gConforms
Mold and yeast counts (potato dextrose agar method)≤100 CFU/g eachBoth conform
Heavy metals
Arsenic (ICP optical emission spectrometry)≤0.5 ppm (detection limit 0.2 ppm)Not detected (conforms)
Heavy metals and cadmium (ICP optical emission spectrometry / sodium sulfide colorimetry)≤5.0 ppm as lead, cadmium ≤0.5 ppmNone detected (conforms)
Total mercury (gold amalgam atomic absorption spectrophotometry)≤0.5 ppm (detection limit 0.01 ppm)Not detected (conforms)
Endotoxin
Endotoxin, freeze-dried (gel-clot method)In accordance with the General Tests of the Japanese Pharmacopoeia, 18th EditionBelow 0.15 EU/mL (conforms)Commissioned laboratory: Japan Food Research Laboratories (JFRL). Performed on a freeze-dried lot (Lot No.NMNF1).

* Certificates of Analysis issued by: Nihon Sogo Iryo Seiyaku Co., Ltd., Japan Food Research Laboratories (JFRL), and Japan Food Inspection Corporation (a testing laboratory registered with the Ministry of Health, Labour and Welfare).

* Only products that pass all of the above tests are supplied. Test results may vary from lot to lot.

Safety record

Zero serious safety incidents
since our founding.

In the stem cell conditioned medium market, incidents caused by improper product management have been reported. TechnoCell has not had a single serious safety incident since its founding. Cleanroom manufacturing, lot-by-lot safety testing, and oversight by doctorate-holding specialists — a design philosophy of preventing incidents runs through every step of our process.

0incidents

Serious safety incidents

Not a single incident since our founding.

7screens

All infectious disease screens negative

HIV-1 and -2 / HBV / HCV / HTLV-1 and -2 / syphilis (stem cell secretome). Human transmissible spongiform encephalopathy is also confirmed negative.

4metals

Heavy metals: none detected

Arsenic, total mercury, lead, and cadmium (β-NMN)

* About incidents reported in the market: In November 2023, an industry association reported a fatality associated with the use of stem cell conditioned medium. The cause was attributed to product contamination and improper management; the case is unrelated to TechnoCell products. We take it seriously and continue to strengthen our quality controls.

Documents

Test Reports and Composition Data

Certificates of Analysis, composition data, and SDS for each product are available to medical institutions on request.

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