Suppliers and packagers for QALSODY

QALSODY

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 Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887	NDA	Biogen Inc.	64406-109-01	1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE	2023-04-25

Suppliers for the Pharmaceutical Drug: QALSODY

Last updated: August 2, 2025

Introduction

QALSODY, known generically as soduralmab, is a novel therapeutic agent developed by Eli Lilly for the treatment of amyotrophic lateral sclerosis (ALS). Its approval by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), marked a significant milestone in ALS management, appealing to clinicians and patients seeking disease-modifying options. The supply chain for QALSODY is critical to its commercialization, ensuring reliable access, quality, and regulatory compliance. This article explores the landscape of suppliers involved in the manufacturing, sourcing of raw materials, and distribution networks underpinning QALSODY, providing an in-depth understanding of its procurement ecosystem.

Manufacturing of QALSODY

QALSODY is a monoclonal antibody therapy, requiring sophisticated biotechnological manufacturing processes. The primary manufacturing takes place at Eli Lilly’s specialized biologics facilities, which adhere to Good Manufacturing Practice (GMP) standards. Eli Lilly’s in-house manufacturing capabilities are complemented by an extensive network of suppliers providing raw materials, bioreactor components, and specialty chemicals essential for antibody production.

Raw Material Suppliers

The production of monoclonal antibodies like QALSODY depends on high-purity raw materials such as cell culture media, stabilizers, and buffer components. Key suppliers typically include:

• Cell Culture Media: Companies like Thermo Fisher Scientific, GE Healthcare, and Sigma-Aldrich supply cell culture media formulated for CHO (Chinese hamster ovary) cells, the standard host line used in monoclonal antibody manufacturing. These media must meet strict quality standards to prevent contamination and ensure batch consistency.

• Reagents and Buffers: Suppliers such as MilliporeSigma and Thermo Fisher Scientific provide chromatography resins, buffers, and cleaning agents used in downstream processing, purification, and formulation.

• Nucleic Acid and Cell Line Development: Companies like ATCC and Sigma-Aldrich supply cell lines, clones, and genetic materials necessary for initial development phases.

Bioprocessing Equipment and Consumables

The manufacturing process relies on high-grade bioreactors, filtration systems, and chromatography columns. Major suppliers include:

• GE Healthcare (now Cytiva): Offers single-use bioreactors, chromatography columns, and filtration systems integral to monoclonal antibody manufacturing.

• Thermo Fisher Scientific: Supplies bioprocessing sensors, filtration devices, and automation tools.

• Pall Corporation: Provides sterilizing-grade filters and filtration components.

Drug Substance and Finished Product Manufacturing

Eli Lilly operates several contract manufacturing organizations (CMOs) globally to scale production and ensure supply chain resilience. Notable CMOs involved in QALSODY production include:

• Boehringer Ingelheim: Has previously partnered with Lilly for biologics manufacturing, offering GMP bioreactor capacity.

• Samsung Biologics: A South Korean CMO providing scalable production capabilities, especially for filling and finishing operations.

• WuXi Biologics: Engaged in global contract manufacturing, specializing in biologics with a focus on quality and speed.

These CMOs maintain strict oversight of quality, sourcing raw materials from approved suppliers and complying with regulatory standards.

Distribution Network and Logistics

QALSODY’s distribution involves a tightly managed cold-chain logistics system to preserve product integrity from manufacturing facilities to clinics and hospitals. Logistics partners include:

• UPS Healthcare and DHL Express: Specialize in temperature-controlled freight, providing real-time tracking and compliance with biosafety standards.

• McKesson and Cardinal Health: Distribute to healthcare providers, ensuring availability across North American and global markets.

Pharmaceutical supply chains now heavily rely on serialization and track-and-trace technology to prevent counterfeiting and ensure transparency, which are integrated into QALSODY’s distribution process.

Regulatory and Quality Considerations

Suppliers contributing to QALSODY’s supply chain must meet rigorous regulatory requirements outlined by agencies such as the FDA, EMA, and others. This includes GMP compliance, validated manufacturing processes, and comprehensive quality assurance systems. Eli Lilly maintains stringent supplier qualification programs, conducting audits and continuous monitoring of their supply base.

Emerging Trends and Supply Chain Resilience

The COVID-19 pandemic underscored the vulnerabilities within biologics supply chains. To mitigate risks, Eli Lilly and its partners have diversified sourcing strategies, establishing multiple supplier relationships and regionalized manufacturing hubs. Investment in digital supply chain management and real-time data analytics has further enhanced responsiveness and resilience.

Conclusion

The supply chain for QALSODY exemplifies the complexity of modern biologic pharmaceuticals, involving advanced raw material suppliers, contract manufacturing organizations, and sophisticated logistics providers. Ensuring a steady, high-quality supply depends on robust collaboration, strict adherence to regulatory standards, and adaptive strategies to global uncertainties. For stakeholders, understanding these supplier networks aids in strategic procurement, risk management, and long-term planning for this innovative ALS therapy.

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Key Takeaways

• QALSODY’s manufacturing involves a global network of high-quality raw material suppliers, primarily from Thermo Fisher Scientific, MilliporeSigma, and others specializing in cell culture components.

• Contract manufacturing organizations such as Samsung Biologics and WuXi Biologics play pivotal roles in scaling production and ensuring supply chain continuity.

• Cold-chain logistics providers like UPS Healthcare and DHL guarantee product stability from manufacturing to clinical use.

• Strict regulatory standards drive supplier qualification and quality assurance processes, safeguarding product safety and efficacy.

• Diversification and digital supply chain tools are increasingly vital in managing disruptions and maintaining reliable supply for biologic drugs like QALSODY.

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FAQs

1. Who are the primary raw material suppliers for QALSODY?

Leading suppliers include Thermo Fisher Scientific and MilliporeSigma, which provide cell culture media, buffers, and chromatography reagents compliant with pharmaceutical standards.

2. Are there contract manufacturing partners involved in producing QALSODY?

Yes. Eli Lilly collaborates with CMOs such as Samsung Biologics, WuXi Biologics, and previously Boehringer Ingelheim to produce the biologic at scale.

3. How does the supply chain ensure the quality of QALSODY?

Through rigorous qualification processes, supplier audits, regulatory compliance checks, and continuous quality monitoring, ensuring raw materials and finished products meet global standards.

4. What logistics providers handle QALSODY’s distribution?

Major logistics firms include UPS Healthcare and DHL Express, specialized in temperature-sensitive biologics transport, coupled with healthcare distributors like McKesson.

5. How does Eli Lilly mitigate risks in the supply chain for QALSODY?

By diversifying suppliers, regionalizing manufacturing, leveraging digital track-and-trace systems, and maintaining contingency planning to address potential disruptions.

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Sources:

1. Eli Lilly. “QALSODY (soduralmab) prescribing information.” 2022.
2. FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations.” 2023.
3. Cytiva. “Bioprocessing Equipment and Solutions.” 2023.
4. WuXi Biologics. “Global Contract Manufacturing Services.” 2023.
5. DHL Healthcare. “Cold Chain Logistics for Biologics.” 2023.