tegsedi: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172	NDA	Akcea Therapeutics, Inc.	72126-007-01	4 TRAY in 1 CARTON (72126-007-01) / 1 SYRINGE in 1 TRAY (72126-007-02) / 1.5 mL in 1 SYRINGE	2018-10-05
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Overview of TEGSEDI

TEGSEDI (inotersen) is a groundbreaking therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hereditary transthyretin amyloidosis (hATTR amyloidosis) with polyneuropathy. Developed by Akcea Therapeutics, a subsidiary of Ionis Pharmaceuticals, TEGSEDI is a once-weekly subcutaneous antisense oligonucleotide therapy. Its approval marked a significant advancement in precision medicine, targeting the genetic underpinnings of rare, life-threatening neurodegenerative conditions.

The innovative mechanism of TEGSEDI involves reducing transthyretin (TTR) production in the liver, thereby preventing amyloid fibril formation that damages nervous and cardiac tissues. Given its niche application and complex manufacturing requirements, TEGSEDI requires a specialized supply chain with high-quality standards to ensure consistent efficacy and safety.

Manufacturing and Supply Chain Overview

The primary manufacturer of TEGSEDI is Ionis Pharmaceuticals, in collaboration with Akcea Therapeutics. The production process is highly intricate, involving the synthesis of antisense oligonucleotides (ASOs), which demand advanced chemical, biochemical, and quality control processes to meet stringent regulatory standards.

Ionis Pharmaceuticals’s facilities in the United States are responsible for the synthesis, purification, and formulation of TEGSEDI. Their manufacturing sites are Good Manufacturing Practice (GMP)-certified, ensuring compliance with global quality standards. Once produced, TEGSEDI is distributed to licensed specialty pharmacies, which are authorized to dispense this exclusive therapy to approved patients.

Key Suppliers of Raw Materials

The production of TEGSEDI relies on high-quality raw materials, primarily chemically synthesized nucleotides, phosphorothioate modifications, and other oligonucleotide synthesis reagents. The supply chain for these raw materials involves several specialized chemical suppliers worldwide.

1. Chemical Building Blocks Suppliers

Original Suppliers: Major providers include Thermo Fisher Scientific, Merck (MilliporeSigma), and ChemGenes Corporation. They supply phosphoramidites, nucleoside phosphates, and other core building blocks necessary for ASO synthesis.
Customization and Quality Control: Suppliers must deliver materials with ultra-high purity (>99.9%) to avoid impurities that could compromise therapeutic efficacy or safety.

2. Oligonucleotide Synthesis Reagents

Phosphorothioate Modifications: Critical for enhancing the stability and affinity of TEGSEDI. Key providers include TriLink BioTechnologies (a part of Merck), Sigma-Aldrich, and local specialized reagent firms.
Linkers and Conjugates: Suppliers of linkers and conjugation moieties ensure targeted delivery, although TEGSEDI primarily relies on its chemical modifications for stability.

3. Manufacturing and Formulation Equipment Suppliers

High-precision automated synthesizers from companies like Duwenzi or Multiplex provide the scale-up capabilities necessary for commercial production.

4. Contract Manufacturing Organizations (CMOs)

While Ionis Pharmaceuticals manages core synthesis, some manufacturing steps, such as formulation, fill-finish, and packaging, are outsourced to specialized CMOs. These include:

Catalent – for fill-finish operations at their sterile manufacturing facilities.
Baxter International – for sterile secondary packaging and distribution.

Distribution Channels and Supply Chain Partners

Specialty Pharmacies and Distributors: TEGSEDI is supplied only through certified specialty pharmacies due to its complex administration and monitoring requirements. Notable partners include:

Accredo (a subsidiary of CVS Health)
Kite Pharma (for personalized therapies)
Other designated specialty distributors that ensure temperature-controlled logistics and secure handling.

Logistics Providers: Temperature-sensitive transportation is critical. Leading cold chain logistics firms such as DHL Thermonet and FedEx Custom Critical handle shipping, ensuring the drug remains stable during transit.

Regulatory and Quality Assurance

Suppliers and distribution partners must adhere strictly to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Regulatory agencies such as the FDA, EMA, and other health authorities conduct audits and enforce compliance to prevent contamination, mislabeling, or supply shortages.

Emerging and Future Suppliers

As demand for TEGSEDI increases globally, suppliers are expanding capacity, and alternative raw material sources are being explored. Notably, several Chinese and Indian chemical manufacturers are investing in process improvements to meet international standards, potentially diversifying the supply base.

Furthermore, competition for raw materials, especially phosphorothioate oligonucleotides, could influence pricing and availability, necessitating proactive supplier relationship management.

Conclusion

The supply chain for TEGSEDI intertwines complex chemical manufacturing, stringent regulatory oversight, and specialized distribution channels. The key raw material suppliers, contract manufacturing organizations, and logistics providers play vital roles in ensuring this lifesaving therapy reaches patients reliably. As the market for antisense oligonucleotides expands, supply chain resilience and diversification will be essential for uninterrupted drug availability.

Key Takeaways

TEGSEDI’s manufacturing relies on high-purity raw materials from global chemical suppliers specializing in nucleotides and oligonucleotide modifications.
The production process involves state-of-the-art GMP facilities led by Ionis Pharmaceuticals, with outsourced formulating and packaging handled by select CMOs.
Distribution is tightly controlled through licensed specialty pharmacies and temperature-controlled logistics providers to maintain product integrity.
The evolving landscape of raw material suppliers, especially in emerging markets, presents opportunities and challenges in ensuring consistent supply.
Strategic supplier relationships, rigorous quality standards, and supply chain diversification are pivotal for delivering TEGSEDI to patients worldwide.

Frequently Asked Questions (FAQs)

Who manufactures TEGSEDI?
TEGSEDI is primarily manufactured by Ionis Pharmaceuticals in partnership with Akcea Therapeutics. The core synthesis occurs in GMP-certified facilities managed by Ionis.
What raw materials are critical for TEGSEDI production?
The therapy’s synthesis requires high-purity nucleoside phosphorothioate oligonucleotides, phosphoramidite building blocks, and specialized conjugates supplied by chemical manufacturers such as Thermo Fisher, Merck, and ChemGenes.
How is TEGSEDI distributed to patients?
It is distributed exclusively through licensed specialty pharmacies utilizing temperature-controlled logistics providers to ensure drug stability during transit.
Are there multiple suppliers for TEGSEDI’s raw materials?
While major suppliers are established, the ongoing need for raw materials encourages diversification to prevent supply disruptions, especially from emerging manufacturers in Asia.
What challenges does the TEGSEDI supply chain face?
Key challenges include ensuring raw material purity, managing global demand, maintaining cold chain logistics, and ensuring compliance across multiple regulatory jurisdictions.

Sources

Suppliers and packagers for tegsedi

tegsedi

Suppliers for the Pharmaceutical Drug: TEGSEDI