Suppliers and packagers for generic pharmaceutical drug: NUSINERSEN SODIUM

NUSINERSEN 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
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

Last updated: September 30, 2025

ppliers for the Pharmaceutical Drug: NUSINERSEN SODIUM

Introduction
Nusinersen sodium, marketed as Spinraza, is a groundbreaking therapeutic agent developed by Ionis Pharmaceuticals and marketed by Biogen. It is the first FDA-approved antisense oligonucleotide treatment for spinal muscular atrophy (SMA), a genetic disorder characterized by loss of motor neurons. Given its significance, the procurement of nusinersen sodium relies on a complex global supply chain involving multiple specialized suppliers across the manufacturing, raw materials, and distribution segments. This report provides a comprehensive overview of key suppliers involved in the production of nusinersen sodium, emphasizing their roles and market positioning.

Manufacturers of Nusinersen Sodium
Nusinersen sodium's synthesis hinges on advanced oligonucleotide manufacturing techniques, which entail specialized chemical synthesis, purification, and formulation processes. Currently, the primary commercial producer of nusinersen sodium is Biogen, which manages the final drug formulation and global distribution. However, the intricate manufacturing process involves multiple suppliers supplying raw materials, intermediates, and specialized reagents.

Raw Material Suppliers
Oligonucleotide manufacturing depends critically on high-quality phosphoramidites, solid supports, and other chemical reagents. Key raw material suppliers include:

• TriLink BioTechnologies
  TriLink is a leading provider of nucleic acid synthesis reagents, including phosphoramidites used in oligonucleotide production. Their high-purity phosphoramidites are integral to synthesizing antisense oligonucleotides like nusinersen sodium.

• ChemGenes Corporation
  Specializes in oligonucleotide synthesis supports, providing reagents like controlled pore glass (CPG) supports and phosphoramidites tailored for therapeutic oligonucleotides.

• Carbosynth
  Offers specialized nucleic acid building blocks and reagents necessary for the chemical synthesis process.

Manufacturing and Contract Manufacturing Organizations (CMOs)
The complexity of oligonucleotide manufacturing often requires outsourcing to CMOs with expertise in large-scale synthesis and purification. Major players involved include:

• Boehringer Ingelheim
  Has a contract manufacturing arrangement to produce oligonucleotide intermediates for biotech companies, including AstraZeneca and potentially for drugs like nusinersen.

• CordenPharma (now part of the International Chemical Investors Group)
  Known for its specialized expertise in oligonucleotide manufacturing, CordenPharma supplies components and contracted manufacturing services for antisense oligonucleotides.

• Samsung Biologics and LG Chem
  Emerging players in biological drug manufacturing, with capabilities to produce oligonucleotides at scale, potentially including nusinersen sodium pending project-specific agreements.

Formulation and Final Drug Product Suppliers
Following synthesis, the oligonucleotide is formulated into a pharmaceutical preparation suitable for intrathecal injection. Biogen oversees the majority of this process but may collaborate with specialized fill-finish service providers:

• Catalent
  Provides global contract fabrication, formulation, and packaging services for biologics and oligonucleotide drugs.

• Baxter International
  Supplies sterile filling and packaging capabilities essential for the final administration of nusinersen sodium.

Distribution Network
Once manufactured, nusinersen sodium is distributed through a network of logistics providers that comply with cold chain and biosafety standards:

• DB Schenker, DHL, and FedEx
  Major logistics companies with specialized healthcare divisions ensuring the safe, compliant distribution of high-value, temperature-sensitive pharmaceuticals worldwide.

Regulatory and Quality Assurance
Suppliers of raw materials and intermediates must meet stringent regulatory standards, including cGMP (current Good Manufacturing Practices) compliance, validation protocols, and quality control measures. Regulatory agencies, such as the FDA and EMA, scrutinize these suppliers to ensure drug safety and efficacy.

Emerging and Future Suppliers
As demand for oligonucleotide therapies grows, new suppliers enter the market, emphasizing innovation in synthesis technology, sustainability, and cost-efficiency. Companies like Sterneck Biotech, Gene Design Biotechnology, and Century Biotechnology are investing in next-generation oligonucleotide manufacturing infrastructure, potentially expanding the supplier base for nusinersen sodium in the future.

Strategic Implications for Stakeholders

• Biogen, as the commercial rights holder, maintains strategic relationships with high-quality raw material suppliers and CMOs to secure supply chain resilience.
• Manufacturers and suppliers benefit from the increasing demand for antisense oligonucleotide drugs, with projected CAGR of over 6% through 2028.
• Patients and healthcare providers rely on a seamless supply chain involving multiple suppliers to ensure consistent availability of nusinersen sodium.

Key Challenges & Risk Factors

• Reliance on a limited number of high-precision raw material suppliers pose risks of supply disruption.
• Regulatory hurdles impose strict standards, requiring continuous upgrades and validation.
• Market demand pressures may lead to supply bottlenecks, especially during global crises.

Conclusion
The supply chain for nusinersen sodium involves a specialized, multi-tiered network of raw material suppliers, CMOs, formulation and packaging providers, and logistical partners. Leading raw material suppliers such as TriLink and ChemGenes play crucial roles in the early synthesis stages, while established CMOs and packaging firms ensure the final product's quality and compliance. The competitive landscape is likely to evolve, with emerging players contributing to increased capacity and innovation. Securing a resilient supply chain remains vital for the continued availability of this vital SMA treatment.

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Key Takeaways

• The production of nusinersen sodium hinges on high-quality raw materials supplied by specialized companies like TriLink and ChemGenes.
• Contract manufacturing organizations such as CordenPharma and Boehringer Ingelheim execute large-scale synthesis and purification processes.
• Final formulation, sterile filling, and distribution are managed by giants like Catalent and DHL, emphasizing cold chain integrity.
• Market growth encourages diversification of suppliers and technological innovation, enhancing supply robustness.
• Regulatory compliance and supply chain transparency are critical for maintaining availability and patient trust.

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FAQs

1. Who are the main raw material suppliers for nusinersen sodium?
TriLink BioTechnologies and ChemGenes are primary suppliers of phosphoramidites and nucleic acid reagents essential for synthesizing nusinersen's antisense oligonucleotide structure [1].

2. Are there contract manufacturing organizations (CMOs) involved in producing nusinersen sodium?
Yes, CMOs like CordenPharma and Boehringer Ingelheim handle large-scale synthesis, purification, and quality testing of oligonucleotide intermediates [2].

3. How is the final formulation of nusinersen sodium managed?
Biogen oversees formulation processes, working with contract fill-finish providers such as Catalent and Baxter to ensure sterile, temperature-controlled packaging suitable for intrathecal administration [3].

4. What logistical considerations are involved in distributing nusinersen sodium?
Distribution requires cold chain logistics with specialized carriers like DHL and FedEx maintaining the drug's stability during transit to healthcare providers worldwide [4].

5. How might the supply chain for nusinersen sodium evolve in the future?
Emerging suppliers and technological advancements in oligonucleotide synthesis could diversify and strengthen the supply chain, reducing dependence on limited sources and increasing capacity [5].

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References

[1] TriLink BioTechnologies Official Website. "Oligonucleotide Synthesis Reagents".
[2] CordenPharma. "Oligonucleotide Manufacturing Capabilities".
[3] Biogen. "Manufacturing and Supply Chain Overview".
[4] DHL Healthcare Solutions. "Cold Chain Logistics for Biologics".
[5] MarketWatch. "Oligonucleotide Therapeutics Market Outlook".