Active Pharmaceutical Ingredient

Cerliponase Alfa

Also known as: Brineura (brand)

CAS: 1465549-79-4 Enzyme Replacement Rare Disease Bulk Supply Available
Cerliponase Alfa API Manufacturer India | Mediocon Inc
Cerliponase Alfa — Pharmaceutical Grade API

Product Overview

CAS No: 1465549-79-4  |  MF: N/A (Recombinant Enzyme)  |  MW: ~66 kDa

Cerliponase Alfa is a recombinant form of human tripeptidyl peptidase 1 (TPP1) enzyme used for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), a rare and fatal lysosomal storage disorder in children. It is administered directly into the cerebrospinal fluid via intraventricular infusion. Mediocon Inc supplies pharmaceutical-grade Cerliponase Alfa API for biopharmaceutical manufacturers.

Key Features

  • Recombinant TPP1 enzyme replacement
  • IP/BP/EP/USP compliant quality
  • Treats CLN2 (Batten disease variant)
  • Intraventricular CSF administration

Applications

  • CLN2 neuronal ceroid lipofuscinosis treatment
  • Rare pediatric neurology
  • Intraventricular enzyme infusion
  • Biopharmaceutical formulation

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameCerliponase Alfa
Also Known AsBrineura (brand)
CAS Number1465549-79-4
Molecular FormulaN/A (Recombinant Enzyme)
Molecular Weight~66 kDa
CategoryEnzyme Replacement Therapy / Rare Disease
AppearanceLyophilized Powder / Solution
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Purity≥ 98% (by SEC-HPLC)
EndotoxinNMT 0.5 EU/mg
BioburdenComplies
IdentificationPeptide Mapping Compliant
Storage2–8°C
PackingAs per requirement
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