Description

Picibanil is a lyophilized preparation derived from the low-virulence Su strain of *Streptococcus pyogenes* (group A), widely recognized for its potent immunomodulatory and anti-tumor properties. This product is critical for research and development in advanced immunotherapy, particularly for investigating non-specific immune stimulation and its effects on various malignancies. It serves as an essential biological response modifier for pharmaceutical developers, clinical researchers, and academic institutions focused on oncology and immunology. The material is supplied as a high-purity, standardized preparation to ensure consistent biological activity for experimental and developmental applications.

Application

• Oncology Research: Investigated as an immunotherapeutic agent for activating host immune defenses against solid tumors, including gastric, head and neck, and lung cancers.
• Immunology Studies: Used as a potent non-specific immunostimulant to study macrophage activation, natural killer (NK) cell enhancement, and cytokine induction.
• Pharmaceutical Development: Serves as a key active pharmaceutical ingredient (API) or reference standard in the development of novel cancer immunotherapies.
• Clinical Research: Employed in clinical trials exploring intratumoral or regional administration for localized anti-tumor effects.
• Combination Therapy Models: Studied in preclinical models in combination with chemotherapy, radiotherapy, or other immunotherapies to assess synergistic effects.
• Biological Standard: Acts as a reference material for quality control and potency assays of streptococcal-derived immunotherapeutic products.

Basic Information

Product Name	Picibanil
CAS No.	39325-01-4
Molecular Formula	N/A (Biological Preparation)
Molecular Weight	N/A (Biological Preparation)
Synonyms	OK-432; NSC-B116209; Penicillin-treated Su strain of Streptococcus pyogenes; Su strain lyophilized preparation; Streptococcal preparation OK-432; Picibanil OK-432; Immunomodulator OK-432
EINECS	Contact for details

Quality Control

Our Picibanil is manufactured under strict aseptic conditions and undergoes comprehensive quality testing to ensure batch-to-batch consistency, sterility, and specified biological potency. Each lot is released with a detailed Certificate of Analysis (COA) confirming identity, purity, sterility (according to USP <71>), endotoxin levels (LAL test), moisture content, and biological activity (potency assay). We adhere to current Good Manufacturing Practice (cGMP) guidelines for biological products. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in the original sealed vial within a tightly closed secondary container, protected from light. Store frozen at -20°C or below. This product is hygroscopic (moisture-sensitive). Avoid repeated freeze-thaw cycles. Under these conditions, the product is stable for the duration specified on the certificate. For long-term storage, maintain at -70°C or lower.

Specification

Item	Specification
Appearance	White to off-white lyophilized cake or powder
Identification (Bioassay/Immunological)	Conforms
Potency (KE Units/vial)	As per label claim
Sterility (USP <71>)	Sterile
Bacterial Endotoxins (LAL)	< 10 EU/mg
Moisture Content (Karl Fischer)	< 3.0 %
pH (Reconstituted Solution)	6.0 - 7.5
Protein Content	Reported on COA

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.