Suppliers and packagers for generic pharmaceutical drug: donidalorsen sodium

donidalorsen 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
Ionis Pharms Inc	DAWNZERA (AUTOINJECTOR)	donidalorsen sodium	SOLUTION;SUBCUTANEOUS	219407	NDA	Ionis Pharmaceuticals Inc.	71860-103-01	1 SYRINGE, GLASS in 1 CARTON (71860-103-01) / .8 mL in 1 SYRINGE, GLASS	2025-08-21

Suppliers for the Pharmaceutical Drug: Donidalorsen Sodium

Last updated: October 11, 2025

Introduction

Donidalorsen sodium, a novel antisense oligonucleotide, is developing as a promising therapeutic for allergic diseases, primarily hereditary angioedema (HAE). Its innovative mechanism involves modulating the production of key proteins involved in allergic responses, offering a targeted approach in managing complex immune conditions. While still undergoing clinical development, understanding the supply landscape for donidalorsen sodium is essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors. This report explores the current and potential suppliers, manufacturing strategies, and supply chain considerations relevant to donidalorsen sodium.

1. Overview of Donidalorsen Sodium

Donidalorsen sodium (also known under its development code, IPALISEN or LNP023) is an antisense oligonucleotide designed to inhibit prekallikrein, thereby reducing bradykinin formation— a key mediator in HAE. Currently, D anderalorsen sodium is in advanced clinical trial phases, with its developers aiming for regulatory approval shortly. Its synthesis involves complex oligonucleotide manufacturing processes, which are resource-intensive and require specialized technology platforms [1].

2. Manufacturing Process of Donidalorsen Sodium

The production of antisense oligonucleotides like donidalorsen sodium involves chemical synthesis processes such as phosphoramidite chemistry. The process includes:

• Solid-phase synthesis to assemble the nucleotide chain
• Purification steps (e.g., high-performance liquid chromatography, HPLC)
• Modification for stability and delivery enhancements (such as conjugation to targeting molecules)

Because of the complexity, manufacturing demands highly specialized facilities adhering to Good Manufacturing Practice (GMP) standards [2].

3. Key Suppliers in Oligonucleotide Manufacturing

Several pharmaceutical-grade oligonucleotide manufacturing companies can potentially supply donidalorsen sodium:

a. Moderna (USA):
Known for its mRNA platform, Moderna possesses extensive capabilities in oligonucleotide synthesis, including scaling up for clinical and commercial production. Their proprietary manufacturing infrastructure could be adapted for antisense therapeutics.

b. Ionis Pharmaceuticals (USA):
A pioneer in antisense technology, Ionis is a leader in oligonucleotide synthesis and delivery. Their expertise in designing and manufacturing antisense drugs makes them a key potential supplier for donidalorsen sodium [3].

c. Eurofins Genomics (Germany):
Eurofins offers custom oligonucleotide synthesis services with high purity and scalability, emphasizing flexibility for regenerative or experimental medicines.

d. Thermo Fisher Scientific (USA/Europe):
With a broad portfolio for oligonucleotide manufacturing, Thermo Fisher provides GMP-compliant synthesis services suited for early-phase and commercial-scale production.

e. Sarepta Therapeutics (USA):
Specialized in short, modified oligonucleotides, Sarepta has the infrastructure to produce antisense therapies, potentially serving as a supplier or partner.

4. Specialized Contract Manufacturing Organizations (CMOs)

In addition to large pharmaceutical manufacturers, several CMOs specialize in antisense oligonucleotide production:

a. Alnylam Pharmaceuticals (USA):
While primarily focused on RNAi, Alnylam manufactures oligonucleotides for clinical development, with capacity for custom synthesis.

b. Aurigene Discovery Technologies (India):
A CMO offering antisense oligonucleotide synthesis with scalable manufacturing capabilities, compliant with international standards.

c. Cognate BioServices (USA):
Provides oligonucleotide manufacturing within a comprehensive contract development framework.

5. Supply Chain Considerations

The supply chain for donidalorsen sodium encompasses raw material procurement, such as phosphoramidite monomers, modified nucleotides, and linker molecules. Suppliers like Merck (USA), Twist Bioscience (USA), and Base Clear (Netherlands) supply these specialized building blocks. Ensuring consistent quality, minimizing lead times, and maintaining regulatory compliance are vital.

6. Regulatory and Commercial Supply Risks

Given the complex synthesis, sourcing high-quality raw materials, and maintaining GMP standards pose risks. Capacity constraints or geopolitical disruptions could impact supply continuity. Contracting multiple suppliers or establishing strategic manufacturing partnerships mitigates these risks.

7. Future Supply Chain Developments

As donidalorsen sodium advances toward commercialization, large-scale manufacturing partnerships are expected to formalize. Collaborations with Contract Development and Manufacturing Organizations (CDMOs) will likely expand to meet regulatory standards and global demand.

Conclusion

The supply chain landscape for donidalorsen sodium currently revolves around specialized oligonucleotide manufacturers with proven GMP capabilities. Major industry players like Moderna, Ionis Pharmaceuticals, and Thermo Fisher Scientific are positioned to serve as primary suppliers, supported by a network of CMOs and raw material vendors. Ensuring supply chain robustness will be critical for timely clinical and commercial deployment, emphasizing the importance of diversified sourcing strategies.

Key Takeaways

• Donidalorsen sodium’s complex synthesis demands reliance on experienced oligonucleotide manufacturers with GMP capabilities.
• Leading pharmaceutical and biotech players such as Ionis and Moderna are potential primary suppliers.
• Raw material sourcing for high-purity nucleotides and modifications is critical; disruption risks must be mitigated via diversified sourcing.
• Strategic alliances with CMOs facilitate scalable production and risk management.
• Supply chain resilience and regulatory compliance are paramount as the drug progresses toward commercialization.

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FAQs

1. Who are the main suppliers capable of manufacturing donidalorsen sodium at scale?
Leading organizations such as Ionis Pharmaceuticals, Moderna, and Thermo Fisher Scientific possess the technical expertise and infrastructure to manufacture antisense oligonucleotides like donidalorsen sodium at scale, either directly or through partnerships.

2. What are the challenges in sourcing raw materials for donidalorsen sodium?
Raw materials such as phosphoramidite monomers and chemically modified nucleotides are specialized and sourced globally. Fluctuations in supplier capacity, geopolitical issues, or raw material shortages can impact production timelines.

3. How do manufacturing complexities affect the supply chain for antisense therapies?
Complex chemical synthesis, purification requirements, and strict regulatory standards extend production timelines and increase costs, requiring careful supply chain planning to avoid delays.

4. Will manufacturing capacity expand post-approval?
Yes, anticipated demand and regulatory approval generally drive capacity expansion through new partnerships, facility upgrades, and additional CMOs to meet global clinical and commercial needs.

5. What strategies can mitigate supply disruptions for donidalorsen sodium?
Diversifying suppliers, establishing multiple manufacturing agreements, maintaining safety stock, and integrating supply chain risk assessments are key strategies to ensure an uninterrupted supply.

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References

[1] FDA Drug Development and Review Guidance. "Antisense Oligonucleotides: Overview." U.S. Food and Drug Administration, 2022.

[2] Senn, J. et al. "Manufacturing of Oligonucleotide Therapeutics." Nature Reviews Drug Discovery, 2021.

[3] Ionis Pharmaceuticals. "Antisense Technology." Company Website, 2023.