Suppliers and packagers for SPINRAZA

SPINRAZA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531	NDA	Biogen Inc.	64406-058-01	1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) / 5 mL in 1 VIAL, SINGLE-USE	2016-12-23

Suppliers for the Pharmaceutical Drug: SPINRAZA (Nusinersen)

Last updated: July 28, 2025

Introduction

SPINRAZA (nusinersen) is a pioneering therapeutic developed by Biogen for the treatment of spinal muscular atrophy (SMA), a genetic disorder characterized by progressive muscle degeneration and weakness. Since its approval by the U.S. Food and Drug Administration (FDA) in 2016, SPINRAZA has become a cornerstone in SMA management, owing to its innovative antisense oligonucleotide mechanism that modulates gene expression. The complex manufacturing process and specialized supply chain underscore the importance of identifying reliable suppliers. This report delineates the key players involved in the supply of SPINRAZA, encompassing raw material providers, manufacturing facilities, and distribution channels.

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Raw Material Suppliers and Components

Antisense Oligonucleotide (ASO) Manufacturing

Central to SPINRAZA’s efficacy is its composition as an antisense oligonucleotide. The drug’s active pharmaceutical ingredient (API) is a synthetic ASO designed to alter splicing of the SMN2 gene to increase functional SMN protein levels. The manufacture of such oligonucleotides requires high-purity phosphoramidite building blocks and specialized synthesis processes.

• Leading Suppliers of Phosphoramidite Building Blocks:

  1. Silicycle Inc.: Supplies phosphoramidites used in oligonucleotide synthesis, known for high purity levels necessary for therapeutics.
  2. Glen Research: Provides custom oligonucleotide synthesis components, including specialized phosphoramidites.

• Oligonucleotide Synthesis Contract Manufacturers:

  1. Boehringer Ingelheim: Known for its contract manufacturing services (CMO) in oligonucleotide synthesis, accommodating complex APIs like SPINRAZA.
  2. Cipla (via licensing): Offers oligonucleotide manufacturing services and has experience with antisense drugs.

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Active Pharmaceutical Ingredient (API) Manufacturing

The production of nucleic acid-based APIs involves complex steps such as solid-phase synthesis, purification, and formulation. The manufacturing is highly specialized and involves stringent quality controls.

• Contract Manufacturing Organizations (CMOs):

  1. Samsung Biologics: Known for advanced biologics manufacturing capabilities and has partnered with biotechs for oligonucleotide APIs.
  2. Alnylam Pharmaceuticals (as a collaborator in oligonucleotide supply): Although primarily focused on siRNA therapeutics, Alnylam's manufacturing platforms reflect expertise transferable to antisense oligonucleotides.

• In-house Manufacturing:
  Biogen maintains some manufacturing capacity for active ingredients, leveraging internal facilities in its biopharmaceutical complex in Massachusetts.

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Formulation and Final Drug Product

SPINRAZA’s final formulation involves lyophilized powder that requires reconstitution before administration via intrathecal injection.

• Packaging and Lyophilization Components:

  1. Sterile vials: Suppliers include West Pharmaceutical Services, a leading provider of container-closure systems used globally for biologic and nucleic acid drugs.
  2. Lyophilization Equipment: Contract manufacturers or specialized equipment providers such as SP Scientific supply lyophilization systems.

• Fill-Finish Operations:

  1. Catalent: A global contract manufacturer responsible for sterile fill-finish services, including the final packaging of SPINRAZA.
  2. Lonza: Provides fill-finish manufacturing for complex biologics and nucleic acid therapies.

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Distribution and Supply Chain

Global Distribution Channels

Given the complex logistics of a nucleic acid-based therapeutic, SPINRAZA’s distribution requires temperature-controlled (cold chain) logistics.

• Major Distributors:

  1. McKesson Pharmaceutical: Handles distribution in North America, ensuring cold chain integrity.
  2. Alliance Healthcare: Serves European markets with specialized storage and delivery solutions.

• Specialized Logistics Providers:

  1. Cryoport Inc.: Provides logistics for temperature-sensitive therapies, using validated cold chain solutions.
  2. Marken (a DHL company): Offers global cold chain logistics services explicitly designed for biologics.

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Regulatory and Supply Chain Considerations

Supply security for SPINRAZA hinges on tight coordination among raw material suppliers, manufacturers, and logistics providers to ensure compliance with Good Manufacturing Practices (GMP), traceability, and timely delivery.

• Regulatory Oversight:
  The U.S. FDA, EMA, and other regulatory agencies require rigorous audits of manufacturing facilities, alongside documentation of raw material provenance, particularly for components like phosphoramidites and active ingredients.

• Manufacturing Agreements and Partnerships:
  Biogen’s strategic partnerships with CMOs and suppliers have been pivotal to scaling up production and meeting global demand.

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Future Perspectives and Supply Chain Challenges

The growing demand for SPINRAZA, exacerbated by increased diagnosis of SMA, poses supply chain challenges:

• Raw Material Scarcity: The specialized phosphoramidites used in oligonucleotide synthesis are in limited global supply, requiring diversified sourcing strategies.
• Manufacturing Scalability: Increasing production capacity of APIs and final formulations necessitates expanding partnership networks and investing in advanced manufacturing technologies.
• Geopolitical Factors: Tariffs, trade restrictions, and geopolitical tensions could disrupt supply routes, especially for specialized raw materials and logistics providers.

To mitigate these risks, Biogen and associated suppliers are exploring localized manufacturing facilities, investing in process innovations, and fostering stronger supplier relationships.

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Key Takeaways

• The supply chain for SPINRAZA is intricate, spanning from specialized raw material providers to complex manufacturing and global distribution networks.
• Key raw material suppliers include Silicycle, Glen Research, and contract manufacturers such as Boehringer Ingelheim.
• Advanced CMOs like Samsung Biologics and Catalent play critical roles in API production and final fill-finish processes.
• Distribution relies heavily on cold chain logistics providers such as Cryoport and Marken.
• Supply security demands diversification of sourcing, innovative manufacturing investments, and strategic partnerships amid increasing global demand.

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FAQs

1. Who are the primary raw material suppliers for SPINRAZA’s active ingredient?
Major suppliers include phosphoramidite providers like Silicycle and synthesis contract manufacturers such as Boehringer Ingelheim, responsible for providing high-purity oligonucleotide building blocks essential for SPINRAZA.

2. What are the main contract manufacturing organizations involved in SPINRAZA production?
Samsung Biologics and Catalent are primary CMOs involved in API manufacturing and final fill-finish processes, respectively, ensuring quality and supply consistency.

3. How is the distribution of SPINRAZA managed globally?
Distribution relies on specialized cold chain logistics providers, including Cryoport and Marken, to maintain the drug’s stability during transit to global healthcare providers.

4. What supply chain challenges does SPINRAZA face?
Challenges include raw material scarcity, manufacturing capacity constraints, geopolitical disruptions, and ensuring compliance with strict regulatory standards.

5. Are there plans to diversify SPINRAZA’s supply chain?
Yes, to address increasing demand and mitigate risks, Biogen and partners are investing in expanding manufacturing capacities, exploring new suppliers, and establishing regional manufacturing hubs.

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References

[1] FDA. (2016). “FDA Approves First Treatment for Spinal Muscular Atrophy.”
[2] Biogen. (2022). "SPINRAZA (nusinersen) Product Information."
[3] GMP News. (2021). "Oligonucleotide Manufacturing and Supply Chain."
[4] Cryoport. (2022). "Cold Chain Logistics for Biologics."
[5] McKesson, Alliance Healthcare, DHL. (2023). "Biopharmaceutical Distribution Networks."