L-Asparaginase (E. coli)

Product characteristics
• L-Asparaginase (CAS Number 9015-68-3) is an enzyme catalyses the hydrolysis of asparagine amino acid into aspartic acid and ammonia
• Biologically active in its tetramer form, which consists of four identical subunits, this enzyme has a molecular weight of approximately 141 kDa

THERAPEUTIC PROPERTIES
• L-Asparaginase is used as a therapeutic agent to treat acute lymphoblastic leukaemia in paediatric and adult patients

Product Features
• L-Asparaginase is manufactured using E.coli fermentation and purified through series of chromatography methods
• Purity levels ≥99%, confirmed by orthogonal quality control tests
• Process and product related impurities such as bacterial endotoxins and host cell derived impurities comply with pharmacopeial limits

GMP Quality Statement
• Personnel training records
• Manufactured and tested under GMP guidelines
• Batch-to-batch consistency
• Testing and traceability of raw material
• Documentation of QA, QC and Production
• Records of the maintenance and equipment calibration
• Stability monitors of product shelf life
• Antibiotic-free and solvent-free manufacturing process
• Animal origin free raw materials
• TSE/BSE free certified and comply with IP/USP/EP/BP
• Following ICH Q7 principles to meet international standards
• Drug Master File (DMF) as per ICH M4 guideline

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