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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 VILTOLARSEN
Viltolarsen (Brand: Viltepso) is an antisense oligonucleotide developed by Wave Life Sciences, approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the treatment of Duchenne muscular dystrophy (DMD) in boys. Its manufacturing involves specialized chemical synthesis, oligonucleotide production, and formulation.
Key Manufacturers and Supply Chain Components
Active Pharmaceutical Ingredient (API) Suppliers
The primary suppliers of viltolarsen's API are companies capable of synthesizing phosphorodiamidate morpholino oligomers (PMOs), the backbone chemistry of antisense drugs.
| Company | Location | Capabilities | Notes |
|---|---|---|---|
| Wave Life Sciences | Singapore, United States | In-house synthesis | Wave develops and manufactures its APIs for clinical and commercial use, maintaining proprietary technology. |
| Biontech SE | Germany | Custom oligonucleotide synthesis | Provides GMP-grade oligonucleotides for clinical trials but not confirmed as a supplier of viltolarsen API. |
| Syntagon AB | Sweden | Oligonucleotide manufacturing | Supplies custom oligonucleotides, including PMOs, under GMP conditions. |
Critical Quality Materials
Manufacturing viltolarsen requires high-quality phosphorodiamidate morpholino oligonucleotides and specialized chemistry reagents.
- Reagents: Suppliers include Thermo Fisher Scientific, Merck KGaA (Sigma-Aldrich), and others providing phosphoramidite building blocks.
- Modified Oligonucleotide Synthesis Equipment: Equipment providers include Danaher (e.g., GE Healthcare) and ChemGenes.
Formulation and Packaging
Post-synthesis, viltolarsen is formulated for injection; secondary suppliers include:
- Pfizer (contract manufacturing organizations for fill-finish processes)
- Sartorius (bioprocess equipment)
Manufacturing and Supply Chain Considerations
- GMP Certification: Suppliers must meet Good Manufacturing Practice standards, particularly critical for oligonucleotide synthesis.
- Supply Chain Risks: Limited number of companies capable of producing high-quality PMOs. Disruptions in raw material supply chains could impact production.
- Scaling: Wave Life Sciences has capacity for commercial-scale manufacturing but may engage multiple contract manufacturing organizations (CMOs) for different production stages.
Contract Manufacturing Organizations (CMOs)
Wave Life Sciences utilizes CMOs for late-stage manufacturing and supply:
| CMO | Location | Role | Notes |
|---|---|---|---|
| Samsung Biologics | South Korea | Commercial-scale fill-finish | Selected for its capacity in biologics and sterile filling. |
| Almac | United Kingdom | Fill-finish | Offers clinical and commercial manufacturing. |
Regulatory and Supply Chain Security
- Strategic partnerships extend to suppliers with validated GMP processes.
- Supply continuity relies on multi-source suppliers for raw materials to mitigate shortages.
- Quality control is standardized across suppliers to maintain consistency in potency and safety.
Summary
While Wave Life Sciences primarily develops and produces viltolarsen internally, it relies on multiple external suppliers for key raw materials, GMP-grade oligonucleotides, and formulation services. The limited number of specialized oligonucleotide producers and high regulatory standards narrow the supplier base.
Key Takeaways
- Wave Life Sciences manages API synthesis primarily in-house but collaborates with external GMP suppliers.
- Key raw material suppliers include Thermo Fisher and Sigma-Aldrich.
- Contract manufacturing agreements with Samsung Biologics and Almac ensure product fill-finish.
- Supply chain risks are mitigated through multi-sourcing and validated GMP processes.
- Limited global capacities for high-quality oligonucleotide production create potential bottlenecks.
FAQs
1. Who are the main API suppliers for viltolarsen?
Wave Life Sciences primarily manufactures the API internally. External GMP oligonucleotide suppliers include companies like Syntagon.
2. What raw materials are critical in viltolarsen production?
Phosphorodiamidate morpholino oligomers, phosphoramidite building blocks, and related reagents from Thermo Fisher and Sigma-Aldrich.
3. How is manufacturing capacity scaled for commercial supply?
Wave collaborates with CMOs like Samsung Biologics and Almac, which offer large-scale, GMP-compliant manufacturing and fill-finish services.
4. Are there risks associated with the supply chain?
Yes. Limited number of high-quality oligonucleotide producers and raw material suppliers increase dependency risks.
5. Can other companies produce viltolarsen?
Only those with specialized expertise and GMP-certified facilities in oligonucleotide synthesis, such as Wave or select contractors, can produce viltolarsen at scale.
References
- U.S. Food and Drug Administration. (2020). FDA approves first drug for Duchenne muscular dystrophy in more than 10 years. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-duchenne-muscular-dystrophy-more-10-years
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