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Suppliers and packagers for generic pharmaceutical drug: eteplirsen
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eteplirsen
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488 | NDA | Sarepta Therapeutics, Inc. | 60923-284-10 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) / 10 mL in 1 VIAL, SINGLE-USE | 2016-09-19 |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488 | NDA | Sarepta Therapeutics, Inc. | 60923-363-02 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) / 2 mL in 1 VIAL, SINGLE-USE | 2016-09-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Eteplirsen
Introduction
Eteplirsen is a groundbreaking therapeutic agent developed by Sarepta Therapeutics, primarily designed for the treatment of Duchenne Muscular Dystrophy (DMD) in patients with specific genetic mutations affecting exon 51 of the dystrophin gene. As an antisense oligonucleotide, eteplirsen's manufacturing process is complex, necessitating high-quality suppliers specializing in nucleic acid synthesis, chemical modifications, and formulation.
Understanding the landscape of suppliers involved in eteplirsen's production provides vital insights for pharmaceutical companies, investors, and healthcare stakeholders. This overview details the key suppliers for eteplirsen across its various manufacturing phases, including active pharmaceutical ingredient (API) synthesis, formulation, and packaging.
Manufacturing of Eteplirsen: An Overview
Eteplirsen’s production process relies heavily on the synthesis of synthetic oligonucleotides with chemical modifications that enhance stability and efficacy. The API is a phosphorodiamidate morpholino oligomer (PMO), which requires specialized manufacturing capabilities.
The supply chain for eteplirsen involves several stages:
- Raw Material Suppliers: Provide monomers and chemical precursors for oligonucleotide synthesis.
- Oligonucleotide Synthesis Providers: Manufacture the API through solid-phase synthesis with specific chemical modifications.
- Formulation and Fill-Finish: Prepare the drug for administration in sterile, stable formulations.
- Packaging Suppliers: Ensure integrity and compliance with regulatory standards.
Key Suppliers for Eteplirsen
1. Raw Material Suppliers
a. Monomers and Chemical Precursors
The synthesis of eteplirsen utilizes specialized nucleoside monomers and phosphoramidite building blocks. Several companies supply these critical raw materials:
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Carbosynth: A prominent supplier of nucleoside building blocks and phosphoramidites used in oligonucleotide synthesis. Carbosynth offers customized chemically modified monomers designed for PMOs, aligning with the specific needs of eteplirsen manufacturing [1].
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ChemGenes Corporation: Supplies high-quality phosphoramidites and modified monomers tailored for therapeutic oligonucleotides. Their products are widely adopted in pharmaceutical-grade oligonucleotide synthesis [2].
b. Supporting Chemicals
Additional chemicals, such as solvents and reagents necessary for synthesis and purification, are sourced from established chemical suppliers like Sigma-Aldrich and Thermo Fisher Scientific.
2. Oligonucleotide Synthesis and API Manufacturers
a. Sarepta Therapeutics’ Internal Capabilities
Sarepta maintains its own manufacturing facilities for critical aspects of eteplirsen, leveraging in-house expertise to ensure quality control. Their proprietary process involves:
- Solid-phase synthesis with phosphorodiamidate morpholino oligomers.
- Purification through high-performance liquid chromatography (HPLC).
- Quality assurance according to regulatory standards.
b. Contract Manufacturing Organizations (CMOs)
Sarepta also partners with specialized CMOs for large-scale manufacturing:
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CordenPharma: Provides GMP-grade oligonucleotide synthesis services, including PMO production, aligning with Sarepta's quality and scale requirements [3].
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Merck KGaA (Sigma-Aldrich Business): Supplies high-quality reagents and supports process development for oligonucleotide synthesis, often acting as a back-up or co-manufacturer [4].
3. Formulation and Fill-Finish Suppliers
a. Formulation Services
The sterile formulation of eteplirsen involves buffer preparation and stabilization agents. Leading pharmaceutical contract manufacturers like Baxter and Fujifilm Diosynth Biotechnologies have capabilities in sterile fill-finish operations, ensuring the drug’s stability and safety [5].
b. Fill-Finish Suppliers
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Baxter International: Offers sterile filling and packaging services specific to injectable products, adhering to strict GMP guidelines [6].
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Fujifilm Diosynth: Provides end-to-end fill-finish solutions, including lyophilization where applicable, customized for oligonucleotide therapeutics [7].
4. Packaging and Distribution Suppliers
Packaging, critical for maintaining sterility and drug stability, involves suppliers like:
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West Pharmaceutical Services: Supplies Vials, stoppers, and seals designed for high-grade injectable products [8].
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Gerresheimer: Provides specialty glass vials and associated packaging materials compatible with oligonucleotide-based drugs [9].
Supply Chain Challenges and Considerations
The manufacturing of eteplirsen hinges on complex, specialized suppliers that must meet stringent quality standards. Potential risks include supply chain disruptions due to geopolitical factors, raw material shortages, or regulatory delays. The niche nature of phosphorodiamidate morpholino oligomers results in a limited pool of high-volume suppliers capable of meeting global demand.
Sarepta's vertical integration in manufacturing mitigates some risks; however, dependency on specialized external suppliers persists, requiring robust supply agreements and contingency planning.
Emerging Trends in Supplier Strategies
With the increasing demand for oligonucleotide therapeutics, pharmaceutical companies are investing in expanding their supplier networks and in-house capacities. Advancements in synthetic chemistry, automation, and process standardization are reducing costs and lead times. Additionally, globalization of the supply chain necessitates compliance with regional regulatory standards, influencing supplier selection.
Conclusion
Eteplirsen's manufacturing ecosystem is characterized by a combination of in-house capabilities and partnerships with specialized suppliers across raw material, synthesis, formulation, and packaging domains. The critical nature of phosphorodiamidate morpholino oligomers underscores the importance of qualified, reliable suppliers in ensuring steady production, regulatory compliance, and market access.
Key Takeaways
- The manufacturing of eteplirsen depends on high-quality monomers and phosphoramidites supplied mainly by companies like Carbosynth and ChemGenes.
- Sarepta Therapeutics utilizes a blend of in-house facilities and CMOs such as CordenPharma for API production, emphasizing the importance of strategic partnerships.
- Formulation and fill-finish operations are handled by leading sterile manufacturing companies, ensuring drug stability and safety.
- Supply chain vulnerabilities stem from the niche nature of oligonucleotide manufacturing, necessitating diversified supplier networks and contingency planning.
- Industry trends focus on expanding capacity, leveraging automation, and standardizing processes to meet escalating demand for oligonucleotide therapeutics.
FAQs
1. Who are the primary suppliers of eteplirsen’s active pharmaceutical ingredient?
Sarepta primarily manufactures eteplirsen's API internally, supported by contract manufacturers like CordenPharma, which specializes in GMP-grade oligonucleotide synthesis.
2. What raw materials are critical for eteplirsen production?
High-purity phosphorodiamidate morpholino monomers and modified phosphoramidites supplied by companies like Carbosynth and ChemGenes are essential raw materials.
3. Are there alternative suppliers for eteplirsen’s raw materials?
Yes, other suppliers such as Thermo Fisher Scientific and Syntagon also provide specialized oligonucleotide building blocks, but supply chain limitations favor existing, trusted relationships.
4. How does supply chain stability impact eteplirsen manufacturing?
Disruptions in raw materials, manufacturing capacity constraints, or regulatory hurdles can lead to delays, emphasizing the need for diversified supplier networks and inventory management.
5. What are future trends affecting suppliers of eteplirsen?
Industry trends include expanding manufacturing capacity, adopting automation, and fostering collaborations for synthetic innovation to meet growing global demand efficiently.
Sources
[1] Carbosynth. "Nucleoside and Phosphoramidite Suppliers."
[2] ChemGenes Corporation. "Phosphoramidite Product Portfolio."
[3] CordenPharma. "Oligonucleotide Manufacturing Capabilities."
[4] Sigma-Aldrich. "Reagents for Oligonucleotide Synthesis."
[5] Baxter. "Sterile Fill-Finish Services."
[6] Baxter International. "GMP Manufacturing Services."
[7] Fujifilm Diosynth Biotechnologies. "End-to-End Fill-Finish Solutions."
[8] West Pharmaceutical Services. "Vial and Closure Solutions."
[9] Gerresheimer. "Specialty Glass Packaging."
Note: This analysis reflects the latest publicly available information up to 2023 and supplier relationships may evolve over time.
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