Applications
Glatiramer Acetate is used in pharmaceutical research and drug development across multiple therapeutic areas.
Glatiramer Acetate — Pharmaceutical Peptide API
High-purity peptide API for drug development, clinical research, and regulatory applications
Product Overview
Glatiramer Acetate is Immunomodulatory peptide for multiple sclerosis. It is widely used in pharmaceutical research, drug development, and clinical applications.
Zhaoke Biotech produces Glatiramer Acetate via advanced solid-phase peptide synthesis (SPPS) with stringent quality control. Each batch undergoes HPLC purity analysis, LC-MS identity confirmation, and comprehensive analytical testing to meet research and regulatory-grade standards.
Product Identification and Specifications
| Product Name | Glatiramer Acetate |
| CAS Number | 147245-92-9 |
| Synonyms | Copaxone, Copolymer 1 |
| Molecular Formula | Contact for details |
| Molecular Weight | Contact for details |
| Sequence | Contact for details |
| Sequence Length | Contact for details |
| Homology | N/A |
| Key Modification | N/A |
| Solubility | Soluble in dilute acetic acid and aqueous buffers (pH 2-8); sparingly soluble in neutral water |
| Pharmacological Class | Neurological / CNS Peptide Agent |
| Indications | Relapsing-Remitting Multiple Sclerosis, Clinically Isolated Syndrome |
| Appearance | White to off-white lyophilized powder |
| Purity | ≥99% |
| Grade | Research Grade / RUO |
| Administration Route | Subcutaneous injection (daily) |
Mechanism of Action
Glatiramer acetate is a synthetic polypeptide mixture composed of random sequences of four amino acids designed to mimic myelin basic protein. It acts as an immunomodulator by shifting the T-cell response from pro-inflammatory Th1 to anti-inflammatory Th2 phenotype, inducing antigen-specific regulatory T-cells, and competitively binding to MHC class II molecules. These mechanisms reduce autoimmune demyelination in multiple sclerosis without causing generalized immunosuppression.
Key Features and Benefits
| Feature | Description | Benefit | |
|---|---|---|---|
| GMP-Compliant Manufacturing | Produced under cGMP conditions with full batch records and validated analytical methods per ICH Q7 guidelines | Ensures regulatory compliance for global pharmaceutical markets and accelerates drug approval timelines | |
| ≥99% HPLC Purity | ≥99% purity by HPLC with single impurity ≤0.5%, meeting USP/EP pharmacopeial standards | Meets stringent quality requirements for API registration and commercial drug production | |
| Complete Analytical Package | Full COA with HPLC, LC-MS, AAA, endotoxin, and microbial testing; method validation reports available | Supports regulatory submissions and reduces analytical method development time | |
| DMF/ASMF Available | Drug Master File and Active Substance Master File available for FDA/EDQM submission | Accelerates product registration in US, EU, and other major markets | |
| Scalable GMP Supply | Production capacity from gram to multi-kilogram batches with flexible scheduling | Supports clinical phases through commercial launch without supply interruption | |
| Global Cold Chain Logistics | Validated cold chain with temperature monitoring and compliant documentation for all major markets | Ensures product integrity from production to delivery worldwide |
Suitable Dosage Forms
Quality Standards and COA Specifications
| Test Item | Specification | Method |
|---|---|---|
| Appearance | White to off-white lyophilized powder | Visual Inspection |
| Identity (HPLC) | Retention time matches reference standard | RP-HPLC |
| Identity (MS) | Molecular weight matches theoretical | MALDI-TOF/ESI-MS |
| Peptide Purity (HPLC) | ≥99.0% | RP-HPLC |
| Related Substances | Total impurities ≤1.0%; Single impurity ≤0.5% | RP-HPLC |
| Water Content | ≤5.0% | Karl Fischer |
| Bacterial Endotoxins | <10 EU/g (GMP grade) | LAL Test (USP) |
| Microbial Limits | TAMC ≤100 CFU/g; TYMC ≤10 CFU/g | USP <61> |
| Residual Solvents | Compliant with ICH Q3C | GC-HS |
| Assay (Content) | 95.0% - 105.0% (on anhydrous basis) | HPLC |
Full batch-specific COA provided with each shipment. Contact us for historical COA requests.
Packaging and Storage
Packaging Details
Storage and Handling
Regulatory Documentation Support
DMF/ASMF
Type II Drug Master File available for US FDA submission; ASMF for EDQM submission
CEP (Certificate of Suitability)
CEP available upon request for European Pharmacopoeia compliance
CMC Documentation Package
Complete Chemistry, Manufacturing, and Controls package including synthesis, specifications, stability data, and impurity profile
GMP Compliance
Manufactured in compliance with ICH Q7, EU GMP Part II, and PIC/S guidelines
Pharmacopeial Standards
Product meets USP, EP, and ChP monograph requirements where applicable
Method Validation Reports
Full analytical method validation reports per ICH Q2(R1) guidelines
Global Export Capabilities
| Region | Capabilities | Documentation |
|---|---|---|
North America (USA, Canada) | Direct shipment; DMF filing support for ANDA/NDA submissions | FDA-compliant COA, DMF Letter of Access, commercial invoice |
Europe (EU, UK, Switzerland) | Full customs clearance; CEP/ASMF support for EU MA applications | EDQM-compliant documentation, REACH statement, COA |
Asia-Pacific (Japan, Korea, Australia, India) | Regional warehouse coordination; NMPA/PMDA/MFDS compliance support | NMPA/PMDA-compliant packages, translated COA available |
Latin America (Brazil, Mexico, Argentina) | MOH registration support for ANVISA/COFEPRIS | Spanish/Portuguese COA translations, MOH registration dossier |
Middle East & Africa (UAE, Saudi, South Africa) | GCC/SFDA registration support; halal certification available | SFDA-compliant documentation, halal certificate, FSC |
One-Stop Supply Chain Services
| Service | Description | Value |
|---|---|---|
| API Sourcing | Direct access to cGMP manufacturing with validated peptide synthesis, purification, and analytical capabilities | Eliminates multi-vendor coordination; consistent quality across all batches |
| Quality Assurance | Independent batch release testing, full traceability, and comprehensive COA with every shipment | Reduces quality risk and supports regulatory inspection readiness |
| Regulatory Services | DMF/ASMF preparation, CMC documentation compilation, and regulatory filing assistance for major markets | Accelerates ANDA/MAA submission timelines and reduces regulatory burden |
| Technical Consultation | Dedicated account manager and technical team for formulation development, method transfer, and stability studies | Expert guidance from preclinical development through commercialization |
| Cold Chain Logistics | End-to-end validated cold chain with real-time temperature monitoring and customs brokerage | Ensures peptide stability and integrity throughout global distribution |
Frequently Asked Questions
Looking for a Complete Peptide Production Solution?
Beyond raw peptide supply, Zhaoke Biotech offers end-to-end production solutions — from custom synthesis and process development to scale-up manufacturing, QC testing, and regulatory documentation. Partner with us for a seamless peptide supply chain experience.
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