Share This Page
Suppliers and packagers for ONPATTRO
✉ Email this page to a colleague
ONPATTRO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922 | NDA | Alnylam Pharmaceuticals, Inc. | 71336-1000-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSE | 2018-08-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ONPATTRO
Introduction
ONPATTRO (patisiran) represents a groundbreaking advancement in the treatment of hereditary ATTR amyloidosis, marketed by Alnylam Pharmaceuticals. As an RNA interference (RNAi) therapeutic, ONPATTRO has reshaped options available for patients suffering from this rare, debilitating disease. This success depends not only on innovative drug design but also on a complex global supply chain that underpins manufacturing, raw material procurement, and distribution. Understanding the current suppliers involved in ONPATTRO’s production provides critical insights into manufacturing resilience, risk factors, and supply chain strategies in the biopharmaceutical industry.
Manufacturing and Active Pharmaceutical Ingredient (API) Suppliers
The core component of ONPATTRO is its active pharmaceutical ingredient (API), the synthetic siRNA molecules. These oligonucleotides are manufactured via highly complex processes requiring specialized raw materials, sophisticated synthesis, and stringent quality control.
API Manufacturing
Alnylam Pharmaceuticals, the developer and marketer of ONPATTRO, oversees the overall manufacturing process, but the actual production of siRNA APIs involves a network of specialized contract manufacturing organizations (CMOs). Several key players are associated with this supply chain:
-
Alnylam’s In-House Production Facilities: While the company maintains in-house capabilities for some manufacturing stages, it relies heavily on external partners to meet global demand [1].
-
Partnered CMOs: Multiple leading biotech manufacturing firms have been engaged to produce high-quality siRNA APIs, including but not limited to:
-
Synthego: Known for oligonucleotide synthesis, Synthego provides GMP-compliant oligonucleotides used as intermediates in API production.
-
Thermo Fisher Scientific: Provides manufacturing services including oligonucleotide synthesis and scale-up, contributing critical raw materials and synthesis steps [2].
-
Alnylam’s strategic manufacturing alliances with CDMOs such as Cytovance Biologics and Boehringer Ingelheim or Eurofins might be involved in various stages of production, although specific contractual details often remain confidential.
-
Raw Materials
The synthesis of siRNA, such as Patisiran, depends on sophisticated raw materials, including nucleotides, phosphoramidites, and specialized solvents:
-
Nucleotide Phosphoramidites: Suppliers like Carbosynth and ChemGenes provide these essential building blocks used in solid-phase oligonucleotide synthesis [3].
-
Modified Nucleotides and MS Components: For enhanced stability and targeted delivery, modified nucleotides are incorporated. Companies such as TriLink BioTechnologies supply these customized reagents vital for API efficacy.
-
Specialized Solvents and Reagents: Supplies from companies like Sigma-Aldrich and Fisher Scientific support synthesis and purification processes.
Delivery System and Formulation Suppliers
ONPATTRO uses lipid nanoparticle (LNP) delivery systems to facilitate siRNA delivery to hepatocytes. The formulation process involves complex lipid components obtained from specialized suppliers.
-
Lipid Components
-
Acuitas Therapeutics: A leading provider of LNP delivery systems, Acuitas supplies custom lipid formulations used in several clinically approved siRNA therapeutics. Their lipids include ionizable cationic lipids, cholesterol, DSPC (distearoylphosphatidylcholine), and PEG-lipids [4].
-
Lipid Manufacturers: Companies like Avanti Polar Lipids provide the high-purity lipids used in LNP formation, including DSPC and cholesterol.
-
-
Manufacturing of LNPs
- The assembly of LNPs is performed by specialized CMOs, which include companies like Alnylam’s partner Becton Dickinson (BD), which has capabilities for scalable lipid nanoparticle manufacturing.
Packaging and Distribution Suppliers
Once manufactured, ONPATTRO is packaged in sterile conditions, often involving:
-
Primary Packaging: Suppliers such as West Pharmaceutical Services and Stevanato Group provide vials, stoppers, and seals that meet pharmaceutical standards.
-
Distribution and Cold Chain Logistics
-
Global logistics providers like DHL and FedEx facilitate cold chain distribution, ensuring the drug’s integrity during transit.
-
Temperature Control Solutions: Specialized shippers with validated cold chain systems are often provided by companies such as World Courier.
-
Supply Chain Challenges and Strategic Considerations
The global supply chain for ONPATTRO reflects the complexity of biopharmaceutical manufacturing, especially for novel RNAi therapies. Challenges include:
-
Raw Material Scarcity: Limited supplier bases for high-purity nucleotides and lipids can lead to bottlenecks.
-
Manufacturing Capacity: Scaling production quickly to meet increasing demand requires multiple reliable partners.
-
Quality Assurance: Maintaining stringent quality standards across diverse manufacturing sites is critical to prevent regulatory issues.
-
Geopolitical and Trade Factors: Cross-border dependencies can introduce risks, particularly in the context of international supply chain disruptions.
Alnylam and its partners mitigate these issues through diversified supplier networks, strategic inventory management, and flexible manufacturing arrangements.
Future Outlook
As demand for RNAi therapeutics like ONPATTRO expands, the supply chain ecosystem is expected to evolve:
-
Vertical Integration: Increasing in-house manufacturing capabilities by Alnylam could reduce reliance on third-party CMOs.
-
New Supplier Relationships: Expanding the supplier base for key raw materials and lipids enhances resilience.
-
Innovations in Delivery: Development of next-generation LNPs and alternative delivery systems may shift supply chain dynamics.
-
Sustainable Sourcing: Growing emphasis on environmentally sustainable suppliers can influence procurement strategies.
Key Takeaways
-
Multiple specialized suppliers are involved in the production of ONPATTRO, ranging from raw material providers to lipid nanoparticle manufacturers.
-
Strategic partnerships with CMOs like Cytovance and Acuitas are essential for scalable, high-quality production.
-
Supply chain resilience hinges on diversifying suppliers for raw materials such as phosphoramidites, lipids, and nucleotides.
-
Distribution networks rely heavily on cold chain logistics providers to maintain drug efficacy until administration.
-
Ongoing industry evolution aims to mitigate current bottlenecks, improve scalability, and bolster supply security for pioneering RNAi drugs like ONPATTRO.
FAQs
Q1: Who are the primary raw material suppliers for ONPATTRO’s API?
A1: Key suppliers include Carbosynth and TriLink BioTechnologies, providing nucleotides and modified building blocks critical for siRNA synthesis.
Q2: What companies manufacture the lipid nanoparticles used in ONPATTRO?
A2: Acuitas Therapeutics and Avanti Polar Lipids supply specialized lipids and formulations used in the LNP delivery system.
Q3: How does the supply chain ensure quality and compliance across different manufacturing partners?
A3: Through rigorous qualification, adherence to GMP standards, and regular audits by Alnylam and regulatory agencies.
Q4: What are the main logistical challenges in distributing ONPATTRO globally?
A4: Maintaining cold chain integrity, timely customs clearance, and coordinating with reliable logistics providers like DHL and FedEx.
Q5: Are there risks associated with supplier concentration in the ONPATTRO supply chain?
A5: Yes, reliance on limited suppliers for high-tech raw materials can lead to bottlenecks, emphasizing the need for diversifying supplier relationships.
References:
[1] Alnylam Pharmaceuticals. (2022). Operational Update and Quarterly Reports.
[2] Synthego. (2023). Oligonucleotide Manufacturing Capabilities.
[3] Carbosynth. (2023). Nucleotide Building Blocks for Oligonucleotide Synthesis.
[4] Acuitas Therapeutics. (2022). Lipid Nanoparticle formulations for RNA therapeutics.
More… ↓
