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Suppliers and packagers for generic pharmaceutical drug: inotersen sodium
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inotersen sodium
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172 | NDA | Akcea Therapeutics, Inc. | 72126-007-01 | 4 TRAY in 1 CARTON (72126-007-01) / 1 SYRINGE in 1 TRAY (72126-007-02) / 1.5 mL in 1 SYRINGE | 2018-10-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Inotersen Sodium
Introduction
Inotersen sodium is a groundbreaking antisense oligonucleotide used primarily to treat hereditary transthyretin amyloidosis (hATTR amyloidosis), a rare, life-threatening genetic disorder. Developed by Ionis Pharmaceuticals and marketed under the brand name Tegsedi, inotersen sodium has gained prominence due to its targeted mechanism of action and clinical efficacy. As demand for this drug increases globally, understanding its supply chain, including key suppliers, is crucial for stakeholders such as healthcare providers, pharmaceutical companies, and investors.
Overview of Inotersen Sodium
Inotersen sodium functions by selectively binding to transthyretin (TTR) mRNA, limiting the production of misfolded TTR proteins that cause amyloid deposits. Given its complex synthesis, procurement, and regulatory considerations, identifying reliable suppliers is vital for ensuring consistent manufacturing and distribution.
Manufacturers and Key Suppliers
1. Ionis Pharmaceuticals
- Role: Developer and initial manufacturer of inotersen sodium.
- Contribution: Ionis Pharmaceuticals designed the antisense oligonucleotide technology underpinning inotersen. They possess the proprietary synthesis platform necessary for producing high-quality, clinical-grade inotersen.
- Global Reach: Besides research, Ionis collaborates with manufacturing partners for large-scale production, ensuring supply continuity for clinical trials and commercial distribution.
2. Lonza Group
- Position: Primary Contract Manufacturing Organization (CMO) Partner.
- Manufacturing Capacity: Lonza is one of the leading providers of oligonucleotide synthesis, offering scale-up manufacturing for pharmaceutical-grade antisense drugs.
- Facilities: Operating advanced facilities in Switzerland and the United States capable of producing inotersen with strict compliance to Good Manufacturing Practices (GMP).
- Significance: Lonza's involvement ensures the scalability necessary for global distribution, adhering to quality standards essential for injectable therapies.
3. Sarepta Therapeutics (Collaborator and Distributor)
- Partnership Role: While Ionis originally developed inotersen, Sarepta has entered into collaborations for manufacturing and distribution, particularly in markets outside the U.S.
- Distribution: Sarepta handles logistics, regulatory compliance, and supply in several regions, including Europe, thus serving as a key conduit in the supply chain network.
Secondary Suppliers and Raw Material Providers
4. Oligonucleotide Raw Material Suppliers
The synthesis of inotersen sodium requires specialized phosphoramidites, modified nucleotides, and purification materials. Leading suppliers include:
- Carbosynth: Supplies specialized chemicals and nucleotides used in oligonucleotide synthesis.
- Sigma-Aldrich (Merck KGaA): Provides reagents for chemical modifications essential in antisense oligonucleotides.
- ChemGenes: Supplies custom phosphoramidites and oligonucleotide building blocks tailored for inotersen production.
5. Packaging and Storage Suppliers
To maintain stability and efficacy, proper packaging is critical:
- Norden Packaging: Provides sterile, tamper-evident vials compatible with injectable drugs.
- Daikyo: Supplies pharmaceutical-grade glass vials ensuring high purity and stability.
Regulatory and Supply Chain Considerations
The manufacturing of inotersen sodium involves complex regulatory oversight, with strict adherence to GMP standards in all supplier facilities. Regulatory agencies like the FDA, EMA, and PMDA require comprehensive audits of manufacturing sites, especially for active pharmaceutical ingredient (API) producers.
Ensuring supply chain robustness entails dual sourcing strategies for critical raw materials, maintaining inventories, and establishing contingency plans for unforeseen disruptions. The reliance on specialized CMO partners like Lonza underscores the importance of strategic supply agreements to mitigate risks.
Emerging and Future Suppliers
Given the limited number of facilities capable of producing antisense oligonucleotides at scale, the pharmaceutical industry is exploring new partnerships:
- Thermo Fisher Scientific: Potential new entrant expanding oligonucleotide manufacturing capacity.
- CDMO Expansion: Several Contract Development and Manufacturing Organizations are investing in dedicated oligonucleotide facilities to meet increasing demand.
These developments aim to diversify sources, enhance supply resilience, and reduce bottlenecks as inotersen’s market expands.
Conclusion
The supply landscape for inotersen sodium is characterized by specialized players, primarily Ionis Pharmaceuticals and strategic partnerships with CMOs like Lonza. Raw material suppliers and packaging firms form the critical backbone of the supply chain, ensuring product integrity from synthesis to delivery. As demand grows, collaboration among these stakeholders, coupled with regulatory rigor, will be pivotal in maintaining steady supply, safeguarding patient access, and supporting future innovation in antisense therapeutics.
Key Takeaways
- Strategic Partnerships Are Central: Lonza and Ionis Pharmaceuticals are key to inotersen’s production, leveraging advanced oligonucleotide manufacturing capabilities.
- Robust Supply Chain Infrastructure Is Vital: Secondary suppliers of raw materials and packaging components are crucial to maintaining manufacturing scalability and product stability.
- Regulatory Compliance Matters: All suppliers must adhere to GMP standards, with ongoing audits and quality assessments integral to supply security.
- Market Expansion Drives Demand for New Suppliers: As inotersen’s use broadens, emerging CDMOs and raw material suppliers are likely to enter the market, enhancing supply resilience.
- Supply Chain Risks Require Proactive Management: Dependence on limited suppliers emphasizes the importance of diversification and contingency planning.
FAQs
1. Who are the primary manufacturers of inotersen sodium?
Ionis Pharmaceuticals developed the molecule, with large-scale manufacturing conducted through contract manufacturers like Lonza, which operate GMP-certified facilities for commercial production.
2. How is raw material sourcing managed for inotersen production?
Raw materials, including phosphoramidites and nucleotides, are supplied by specialized chemical suppliers such as Carbosynth and Sigma-Aldrich, which provide high-purity reagents compatible with GMP standards.
3. What role does Lonza play in the supply of inotersen sodium?
Lonza serves as a contract manufacturing organization responsible for scaling up and producing clinical and commercial quantities of inotersen sodium under strict regulatory compliance.
4. Are there risks associated with the current supply chain?
Yes, given the specialized nature of antisense oligonucleotide manufacturing, reliance on limited suppliers introduces risks. Diversification of suppliers and strategic inventory management are essential for supply stability.
5. What future developments could impact the supply of inotersen sodium?
Emerging manufacturing technologies, new CDMO investments, and regulatory changes could influence the supply landscape. Expansion of oligonucleotide production facilities worldwide will likely improve supply security.
References
- [1] Ionis Pharmaceuticals: Inotersen Development and Manufacturing Capabilities.
- [2] Lonza Group: Manufacturing Expertise for Oligonucleotide Drugs.
- [3] Regulatory Guidelines for GMP Compliance in Oligonucleotide Production.
- [4] Chemical Suppliers for Oligonucleotide Synthesis: Carbosynth, Sigma-Aldrich.
- [5] Industry Reports on Supply Chain and Manufacturing of Antisense Drugs.
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