Description

Alipogene Tiparvovec is a recombinant adeno-associated virus (AAV) vector-based gene therapy product. This advanced therapeutic is designed for the treatment of a specific genetic disorder, representing a significant innovation in the field of precision medicine. It is primarily utilized by biopharmaceutical manufacturers, clinical research organizations (CROs), and advanced therapy medicinal product (ATMP) developers engaged in gene therapy research, process development, and commercial manufacturing.

Application

• Active Pharmaceutical Ingredient (API) in gene therapy formulations for the treatment of lipoprotein lipase deficiency (LPLD).
• Reference Standard for analytical method development, validation, and quality control in biopharmaceutical labs.
• Process Development & Scale-Up for optimizing viral vector production, purification, and fill-finish processes.
• Pre-clinical and Clinical Research to study gene delivery mechanisms, efficacy, and long-term expression.
• Regulatory Submissions, providing the critical material for stability studies and Chemistry, Manufacturing, and Controls (CMC) documentation.

Basic Information

Product Name	Alipogene Tiparvovec
CAS No.	929881-05-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Glybera; AAV1-LPLS447X; alipogene tiparvovec; Adeno-associated virus serotype 1 vector containing the human lipoprotein lipase gene variant LPLS447X; AAV1-LPLS447X; LPL(S447X) gene therapy; AMT-011; AAV1-hLPLS447X
EINECS	Contact for details

Quality Control

Our Alipogene Tiparvovec is manufactured and controlled under a stringent quality management system. Each batch is subjected to comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting the exacting standards required for gene therapy applications. Specifications are aligned with ICH guidelines and relevant pharmacopoeial requirements. A comprehensive Certificate of Analysis (COA) detailing purity, titer, and impurity profiles is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at the recommended temperature (typically -65°C or below) to maintain stability and potency. Avoid repeated freeze-thaw cycles. Handle under appropriate biosafety conditions.

Specification

Item	Specification
Appearance	Clear to slightly opalescent liquid
Identification (qPCR/SDS-PAGE)	Complies
Assay (Vector Genome Titer)	≥ 1.0 x 10¹² vg/mL
Potency (Transduction Assay)	≥ 80% of reference
Purity (HPLC/SEC)	≥ 95.0%
Empty/Full Capsid Ratio (AUC/AEX-HPLC)	Report result
Residual Host Cell DNA	< 10 ng/dose
Residual Host Cell Protein	< 100 ng/dose
Endotoxin	< 5 EU/mL
Bioburden	Sterile
pH	7.0 - 8.0

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.