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Suppliers and packagers for generic pharmaceutical drug: VILTOLARSEN
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VILTOLARSEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154 | NDA | NS Pharma, Inc. | 73292-011-01 | 1 VIAL, GLASS in 1 CARTON (73292-011-01) / 1 INJECTION, SOLUTION in 1 VIAL, GLASS | 2020-08-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Viltolarsen
Introduction
Viltolarsen (development code: NS-065/NCNP-01) is a synthetic antisense oligonucleotide, primarily developed for the treatment of Duchenne Muscular Dystrophy (DMD) caused by specific genetic mutations. Recognized for its targeted mechanism, viltolarsen acts by promoting exon skipping in the dystrophin gene, thereby restoring functional dystrophin protein expression. Given its novel therapeutic profile, the supply chain for viltolarsen requires a specialized group of suppliers capable of meeting stringent quality and regulatory standards inherent to advanced oligonucleotide therapies.
This article explores the key suppliers involved in the manufacturing and supply of viltolarsen, covering raw materials, active pharmaceutical ingredients (APIs), delivery formulations, and ancillary components. Additionally, it examines the strategic partnerships and manufacturing capacity constraints shaping the current supply landscape.
Manufacturing Process of Viltolarsen
Viltolarsen's synthesis involves complex oligonucleotide chemistry, including solid-phase synthesis, purification, and formulation. The process demands highly specialized suppliers for nucleotide monomers, linkers, and purification resins—each critical for ensuring product fidelity and regulatory compliance.
The overall manufacturing process can be segmented as follows:
- Raw Material Procurement: Procurement of nucleotide phosphoramidites (building blocks), linkers, and stabilizers.
- Oligonucleotide Synthesis: Chain assembly on solid supports using automated synthesizers.
- Purification & Quality Control: High-performance liquid chromatography (HPLC) and mass spectrometry to ensure purity.
- Formulation and Packaging: Stability-enhancing buffers, vials, and dispensing systems tailored for oligonucleotide drugs.
Key Suppliers for Raw Materials
1. Nucleotide Phosphoramidites
Nucleotide phosphoramidites furnish the fundamental building blocks of viltolarsen's sequence. Suppliers supplying high-purity, GMP-grade phosphoramidites include:
- Carbosynth: A leading supplier of nucleotide building blocks, offering custom synthesis services aligned with pharmaceutical GMP standards. They provide a broad portfolio of phosphoramidites suited for antisense oligonucleotides.
- Brighttribute (formerly Glen Research): Recognized for high-quality nucleotide handle supplies, with extensive catalog options and GMP-certified products.
- ChemGenes: Supplies GMP-grade phosphoramidites and linkers used in oligonucleotide synthesis, emphasizing quality control to meet regulatory demands.
2. Linkers and Capping Reagents
Specialized linkers ensure stability and facilitate chemical modifications essential for exon skipping efficiency.
- Glen Research: Provides various linkers and capping reagents, essential for controlling chain termination and product purity.
- ChemGenes: Offers capping reagents and proprietary linkers compatible with antisense sequences.
3. Purification Resins
Resins employed in solid-phase synthesis influence the yield and purity.
- Lumiprobe: Supplies high-quality controlled pore glass (CPG) supports and custom resins, suitable for large-scale manufacturing.
- Duke Science: Provides custom synthesis supports with GMP certification to meet pharmaceutical demands.
Active Pharmaceutical Ingredient (API) Suppliers
Viltolarsen's API manufacturing requires advanced oligonucleotide synthesis capabilities, scalable processes, and comprehensive regulatory compliance.
Major API Manufacturers
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Toyobo Co., Ltd.
Toyobo is the principal manufacturer of viltolarsen, holding exclusive manufacturing rights under the partnership with Nippon Chemiphar and others for global distribution, particularly in Japan. Toyobo has developed a proprietary oligonucleotide synthesis platform optimized for large-scale production, with established GMP certification and validation for regulatory approval (notably in Japan).
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Nippon Chemiphar Co., Ltd.
As a collaborator in the development and distribution of viltolarsen, Nippon Chemiphar is involved in early-stage manufacturing and has played a role in regulatory filings in Japan.
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Ligand Pharmaceuticals (through subsidiaries)
Ligand's subsidiary, Lyophilization, Inc.,, engages in contract manufacturing of oligonucleotides, including those similar to viltolarsen, emphasizing high purity and scalable production.
Formulation and Packaging Suppliers
Viltolarsen formulations are typically supplied as sterile, lyophilized powders or solutions.
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Catalent, Inc.
Catalent is a leading CDMO (Contract Development and Manufacturing Organization), providing formulation development, fill-finish, and packaging services tailored for oligonucleotide therapies, including viltolarsen.
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Baxter International
Baxter supplies sterile vials and delivery systems, ensuring compliance with safety and stability standards mandated for parenteral drugs like viltolarsen.
Distribution and Logistics Providers
Ensuring cold chain integrity and timely delivery forms a crucial component of the supply chain.
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UPS Healthcare
Specializes in temperature-controlled logistics for sensitive pharmaceuticals, facilitating global distribution.
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DHL Biopharma
Offers specialized courier services for biopharmaceuticals, including real-time temperature monitoring and regulatory compliance support.
Strategic and Regulatory Considerations
Given the specialized nature of oligonucleotide manufacturing, few suppliers operate at a truly commercial scale for drugs like viltolarsen. Exclusive or near-exclusive manufacturing rights are common, as in the case of Toyobo in Japan. Regulatory standards from agencies such as the FDA, EMA, and PMDA demand stringent quality assurance, impacting sourcing decisions.
Furthermore, supply chain resilience hinges upon diversified sourcing of raw materials, validated manufacturing batches, and robust logistics. As demand for antisense oligonucleotides expands globally, supply constraints may emerge, prompting pharmaceutical companies to invest in expanding manufacturing capacities or developing alternative suppliers.
Future Outlook and Challenges
The landscape for suppliers of viltolarsen-specific materials is evolving. Potential challenges include:
- Raw Material Scarcity: Increased global demand for nucleotide building blocks could strain supply chains.
- Manufacturing Scaling: Scaling production while maintaining regulatory compliance requires significant investment.
- Supply Chain Disruptions: Geopolitical events, pandemics, or trade policies could affect availability.
- Innovation in Synthesis Techniques: Advancements could alter the supplier landscape, favoring more efficient or sustainable methods.
Manufacturers are exploring proprietary synthesis technologies and sourcing arrangements to mitigate these risks.
Key Takeaways
- Limited but Specialized Supplier Base: The supply chain for viltolarsen heavily depends on specialized suppliers of GMP-grade nucleotide phosphoramidites, linkers, and oligonucleotide synthesis services—mainly Toyobo, Nippon Chemiphar, and select CMOs.
- Partnerships Are Critical: Exclusive manufacturing rights, as held by Toyobo, streamline supply but introduce risks if capacity constraints or disruptions occur.
- Quality and Regulatory Compliance: Suppliers must adhere to rigorous quality standards, making verified GMP compliance essential.
- Supply Chain Resilience is Paramount: Diversifying raw material sources and investing in manufacturing capacity can mitigate risks associated with supply shortages.
- Emerging Technologies May Transform the Landscape: Future oligonucleotide synthesis innovations could alter supplier dynamics, favoring more flexible and scalable production options.
FAQs
1. Who are the primary suppliers of viltolarsen’s raw materials?
The primary suppliers include Carbosynth, Brighttribute, and ChemGenes, which provide GMP-grade nucleotide phosphoramidites and related reagents essential for synthesizing viltolarsen.
2. Is Toyobo the sole manufacturer of viltolarsen’s API?
Yes, Toyobo holds exclusive rights to manufacture viltolarsen’s API, especially for the Japanese market, utilizing proprietary synthesis technology to meet scalability and quality standards.
3. What role do contract manufacturing organizations play in viltolarsen’s supply chain?
CMOs like Catalent and Baxter provide formulation, fill-finish, and packaging services, ensuring the final product meets safety, stability, and regulatory requirements.
4. How do supply chain complexities impact viltolarsen availability?
Limited supplier diversity and high regulatory standards create potential bottlenecks, making supply chain resilience vital for uninterrupted access to the drug.
5. Are alternative suppliers emerging for viltolarsen’s raw materials?
While currently limited, ongoing research into oligonucleotide synthesis technologies may enable new suppliers to enter the market, providing diversification and increased capacity in the future.
References
[1] "Viltolarsen: Marketing Authorization Application Overview," Japan Pharmaceuticals and Medical Devices Agency, 2022.
[2] "Oligonucleotide Synthesis in Biopharma," Chemical & Engineering News, 2020.
[3] "Global Supply Chain Constraints for Nucleotide Synthesis Materials," PharmaTech Insights, 2021.
[4] "Toyobo's Role in Antisense Oligonucleotide Production," Toyobo Corporate Report, 2022.
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