Crisantaspase is a recombinant enzyme formulation of L-asparaginase used as an antineoplastic agent. It hydrolyzes the amino acid L-asparagine into aspartic acid and ammonia, reducing extracellular asparagine available to leukemia cells that have limited capacity to synthesize asparagine.
Crisantaspase is a recombinant L-asparaginase enzyme produced using genetically engineered microorganisms. It belongs to the antineoplastic enzyme class and is used in combination chemotherapy for the treatment of acute lymphoblastic leukemia (ALL).
Crisantaspase is also known as calaspargase pegol in its pegylated pharmaceutical form. The enzyme component is L-asparaginase, while the pharmaceutical product incorporates polyethylene glycol (PEG) to modify the enzyme and influence its pharmacokinetic properties.
Crisantaspase catalyzes the hydrolysis of circulating L-asparagine to aspartic acid and ammonia. Depletion of extracellular asparagine limits protein synthesis in susceptible leukemia cells, contributing to inhibition of tumor-cell growth and survival.
Crisantaspase/calaspargase pegol is used as part of multi-agent chemotherapy for acute lymphoblastic leukemia (ALL). The specific approved indication, age group and formulation depend on the applicable regulatory jurisdiction and product.
Crisantaspase can be supplied for pharmaceutical development and manufacturing applications subject to applicable biological-product quality, regulatory and supply requirements.
As a recombinant biological enzyme, quality evaluation should focus on identity, enzymatic activity/potency, protein purity, aggregates, host-cell proteins, residual host-cell DNA, endotoxin, bioburden and other applicable critical quality attributes.
Final release specifications should be based on the approved product specification, validated analytical methods and batch-specific Certificate of Analysis (CoA).
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to Crisantaspase identity by validated biochemical, immunochemical and/or peptide mapping methods |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |