Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme

Hydrolytic Lysosomal Triacylglycerol-specific Enzyme

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-8"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL) that is a lysosomal glycoprotein enzyme produced by recombinant DNA technology in the egg white of eggs laid by genetically engineered chickens.  Purified sebelipase alfa is a monomeric glycoprotein containing 6 N-linked glycosylation sites and has a molecular mass of approximately 55 kDa. The amino acid sequence for sebelipase alfa is the same as the amino acid sequence for human LAL. The specific activity of sebelipase alfa is 195 to 345 units/mg. One unit is the amount of enzyme activity that catalyzes the hydrolysis of 1 micromole of the synthetic substrate 4-methylumbelliferyl oleate per minute at 37°C under specified assay conditions.</p><p>KANUMA (sebelipase alfa) injection is supplied as a sterile, preservative-free, non-pyrogenic clear to slightly opalescent, colorless to slightly colored aqueous solution in single-dose vials for intravenous infusion. Each vial contains sebelipase alfa 20 mg/10 mL. Each mL of solution contains sebelipase alfa (2 mg), citric acid monohydrate (1.57 mg), Human Serum Albumin (10 mg), and trisodium citrate dihydrate (13.7 mg) at pH 5.9.</p></section>

KANUMA

sebelipase alfa

10 ML sebelipase alfa 2 MG/ML Injection

Kanuma

10 ML sebelipase alfa 2 MG/ML Injection [Kanuma]

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