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Description
OK432 is an immunomodulatory agent produced through the lyophilization of Group A Streptococcus pyogenes.
It activates neutrophils, enabling them to effectively kill tumor cells pretreated with IFN-γ or TNF-α. This cytotoxic effect is mediated by the interaction between CD11b/CD18 on neutrophils and ICAM-1 expressed on tumor cells.
Furthermore, OK432 stimulates monocytes to enhance their tumoricidal activity against autologous cancer cells.
In lymphocytes, OK432 induces lymphokine-activated killer (LAK) cell activity, which demonstrates potent cytotoxicity even against NK-resistant tumor cells.
Due to its immunomodulatory and antitumor properties, OK432 is suitable for the development and production of cell-based therapeutics.
OK432 is standardized in Klinische Einheit (KE), a clinical unit of biological activity. The potency is defined such that 1 KE is equivalent to 0.1 mg of the lyophilized bacterial product.
Specifications
| Product | Parameter | Specification | Results |
|---|---|---|---|
| GMP-TL107-0100 | Appearance | Freeze-dried preparation, the form should be white loose body | Compliance |
| Visible Particle | Should be no visible particle | Compliance | |
| Moisture | ≤4.0% | 1.7% | |
| pH | 6.5~7.5 | 7.2 | |
| Mycoplasma | Should be negative | Negative | |
| Sterility | No growth | No growth | |
| GMP-TL107-0500 | Appearance | Freeze-dried preparation, the form should be white loose body | Compliance |
| Visible Particle | Should be no visible particle | Compliance | |
| Moisture | ≤3.0% | 1.3% | |
| Sterility | No growth | No growth | |
| Abnormal Toxicity | Should comply with the regulations | Compliance | |
| Concentration Determination | The difference between bottles shall not exceed ±15% | 1.1% | |
| The average content shall not exceed 90% - 110% of the labeled amount | 97.6% | ||
| Tumor Suppression Test | The life extension rate should not be less than 50% | 91% | |
| Relative Content Determination of Penicillin-thiazole Protein | It shall be less than 0.03% | Compliance | |
| NK Cell Activity Assay | Cytotoxic index T-C by ≥10% | 21.0% |
Features
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Lyophilized Bacterial Immunomodulator
OK432 is produced through lyophilization of Group A Streptococcus pyogenes and supplied as a white, fluffy lyophilized powder.
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Standardized Biological Potency (KE Unit)
Activity is standardized in Klinische Einheit (KE), where 1 KE corresponds to 0.1 mg of the lyophilized bacterial product.
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NK Cell Activation Activity
OK432-activated NK cells exhibit a cytotoxicity index (T–C) ≥15%, with batch result reaching 21.0% in NK cell activity assay.
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Quality-Controlled Safety Profile
Complies with specifications for appearance, moisture (1.7% / 1.3%), pH (6.5–7.5 range), sterility (no growth), mycoplasma negative, and abnormal toxicity testing (where applicable).
Applications
Neutrophil Tumor Cytotoxicity
Activates neutrophils to kill tumor cells pretreated with IFN-γ or TNF-α via CD11b/CD18–ICAM-1 interaction.
Monocyte Antitumor Activation
Stimulates monocytes to enhance tumoricidal activity against autologous cancer cells.
LAK Cell Induction
Induces lymphokine-activated killer (LAK) cell activity in lymphocytes, demonstrating cytotoxicity against NK-resistant tumor cells.
NK Cell Function Studies
Can be used to activate NK cells for cytotoxicity enhancement in in vitro immune function studies.
Stability & Storage
- Lyophilized powder: Stable for 24 months at 2–8°C in the original.
- Reconstitution: Dissolve in sterile Water for Injection, 0.9% NaCl, or PBS (pH 7.4) maintaining final concentration ≥100 µg/mL to prevent adsorption.
- Handling: Aliquot to avoid repeated freeze-thaw cycles.
Cautions
• Research Use Only: This product is not intended for diagnostic or therapeutic use.
• Handling: Prepare solutions using sterile technique. Avoid microbial contamination to maintain activity.
• Storage: Follow recommended storage conditions. Repeated freeze–thaw cycles may reduce performance.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.

