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Overview
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Pegylated L-Asparaginase offering extended half-life for effective leukemia treatment
Product characteristics
• Pegaspargase (CAS Number 130167-69-0) is a PEGylated form of L-Asparaginase, wherein L-Asparaginase is glycol conjugated with mono-methoxy polyethylene glycol (mPEG)
• Pegaspargase exhibits higher catalytic activity and stability with low hypersensitivity
• Molecular weight of Pegaspargase is in the range of 450 to 550 kDa with 90 to 100% PEGylation
• Pegaspargase improves the circulation time in blood and shows resistance to proteolytic reactions
THERAPEUTIC PROPERTIES
• Pegaspargase is used in the treatment of acute lymphocytic leukaemia (ALL), Non-Hodgkin’s lymphoma and when hypersensitive to another form of L-Asparaginase
Product Features
• L-Asparaginase manufactured in the in-house WHO-GMP certified facility is used in the Pegaspargase manufacturing
• Mono-methoxy Polyethylene glycol (mPEG) used is sourced from GMP and ISO 9001-2021 certified facility
• Purity levels ≥95%, confirmed by orthogonal quality control tests
• Process and product related impurities such as bacterial endotoxins and PEG-derived impurities comply to limits set by competent authorities
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 guidelinePlease contact us at for specific academic pricing.
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Overview