Suppliers and packagers for generic pharmaceutical drug: zilucoplan sodium

zilucoplan 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
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834	NDA	UCB, Inc.	50474-990-80	4 CARTON in 1 BOX (50474-990-80) / 7 SYRINGE, GLASS in 1 CARTON / .416 mL in 1 SYRINGE, GLASS	2024-01-03
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834	NDA	UCB, Inc.	50474-991-80	4 CARTON in 1 BOX (50474-991-80) / 7 SYRINGE, GLASS in 1 CARTON / .574 mL in 1 SYRINGE, GLASS	2024-01-03
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834	NDA	UCB, Inc.	50474-992-80	4 CARTON in 1 BOX (50474-992-80) / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS	2024-01-03

Suppliers for the Pharmaceutical Drug: ZILUCOPLAN SODIUM

Last updated: July 29, 2025

Introduction

Zilucoplan sodium is an investigational peptide-based complement inhibitor primarily developed for the treatment of autoimmune and neuromuscular disorders, including generalized myasthenia gravis (gMG). As a peptide therapeutic targeting the complement component C5, zilucoplan offers a promising alternative to monoclonal antibody-based complement inhibitors. Its manufacturers and suppliers are integral to its clinical development, commercialization, and supply chain dynamics. This analysis explores the current landscape of suppliers and manufacturing partners for zilucoplan sodium, focusing on contract manufacturing organizations (CMOs), chemical suppliers, and proprietary synthesis facilities involved in its production.

Manufacturing and Supply Chain Landscape

1. Development and Manufacturing Status

Zilucoplan sodium remains in the developmental phase, with clinical trials assessing its safety, efficacy, and pharmacokinetics. Prominent biotech firms such as Ra Pharmaceuticals (now part of UCB) originally advanced zilucoplan through clinical stages. UCB maintains ownership rights and may establish or outsource manufacturing operations for commercial supply, depending on regulatory approvals and market strategy (source: UCB pipeline overview).

2. Key Suppliers and Contract Manufacturing Organizations (CMOs)

Given the peptide's complex synthesis and stability requirements, pharmaceutical companies depend heavily on specialized CMOs for manufacturing. Several notable players in peptide synthesis and biologics manufacturing are involved or have the potential capacity to supply zilucoplan sodium:

a) Chemical Synthesis Suppliers

• Peptide Synthesis Specialists:
  Peptides like zilucoplan are produced through solid-phase peptide synthesis (SPPS), a process requiring high precision and quality control. Companies such as Bachem AG, GeneDesign, and CPC Scientific are leading providers of custom peptide synthesis. Bachem, in particular, has a history of producing therapeutic peptides at GMP standards, making it a likely partner or supplier for researchers and developers working on zilucoplan.

• Raw Material Suppliers:
  The amino acid precursors and coupling agents necessary for peptide synthesis are procured from suppliers like Ajinomoto, Corbion, and Chem-Impex. These suppliers provide high-purity reagents critical for GMP-compliant manufacturing.

b) Contract Manufacturing Organizations (CMOs)

• Lonza:
  A global leader in biologic and peptide manufacturing, Lonza offers scalable peptide synthesis and formulation services suitable for clinical and commercial supplies. Their facilities are FDA- and EMA-approved, with capabilities aligning with the strict quality standards needed for immunomodulatory drugs.

• Samsung Biologics:
  Known for large-scale biologics production, Samsung has the capacity to produce complex peptides and biologics, potentially serving as a partner for later-phase manufacturing.

• Boehringer Ingelheim:
  Boehringer Ingelheim offers peptide synthesis and biologics manufacturing, with extensive experience in immunomodulatory drugs, aligning with zilucoplan’s therapeutic profile.

3. Quality and Regulatory Considerations

Manufacturing partners must comply with Good Manufacturing Practices (GMP) standards overseen by regulatory agencies such as the FDA and EMA. Quality control involves rigorous purity assessments, peptide characterization, and stability testing.

4. Procurement and Supply Chain Risks

Current reliance on specialized peptide synthesis firms introduces risks related to supply chain disruptions, scale-up challenges, and regulatory approvals. Ensuring diversified supplier relationships and capacity planning remains essential as zilucoplan advances through clinical phases toward possible commercialization.

Market Dynamics and Strategic Implications

1. Partnerships and Licensing Agreements

Development firms often establish strategic partnerships with CMOs to secure supply during late-phase trials and beyond. For zilucoplan, UCB's collaborations and licensing arrangements likely include manufacturing agreements with experienced peptide producers.

2. Scaling and Commercial Production

Post-approval, scale-up entails securing partnership agreements with large-scale biologics manufacturers like Lonza or Samsung. The complexity of peptide synthesis can affect manufacturing timelines and costs, influencing pricing and market penetration strategies.

3. Emerging Suppliers and Innovation

Innovations in peptide synthesis, such as automated solid-phase synthesis and continuous manufacturing, could facilitate more efficient production of zilucoplan in the future. Emerging biotech manufacturers may enter the supply chain, offering cost and quality advantages.

Regulatory and Patent Considerations

The proprietary nature of zilucoplan’s sequence and synthesis process protects its intellectual property (IP). Suppliers involved in manufacturing are often bound by confidentiality agreements and licensing rights that restrict disclosure of detailed processes. Regulatory approval depends on demonstrating consistent quality and supply chain robustness.

Conclusion

The supply chain for zilucoplan sodium encompasses specialized peptide synthesis firms, GMP-grade chemical suppliers, and expert CMOs capable of producing complex biologic peptides at scale. Companies such as Bachem, Lonza, and Samsung Biologics currently represent the backbone of the manufacturing infrastructure. Ensuring diversified supply relationships and adherence to regulatory standards is critical for advancing zilucoplan toward commercialization.

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Key Takeaways

• Specialized peptide synthesis firms like Bachem are central suppliers capable of producing zilucoplan sodium at GMP standards.
• Major CMOs such as Lonza and Samsung Biologics play pivotal roles in scaling production for clinical trials and commercial supply.
• The supply chain’s complexity necessitates rigorous quality control, regulatory compliance, and risk mitigation through diversified supplier relationships.
• Strategic partnerships and licensing agreements underpin the manufacturing process, influencing cost, capacity, and timeline considerations.
• Advances in peptide manufacturing technology could reshape the supply landscape, offering efficiency gains and cost reductions.

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FAQs

1. Who are the primary manufacturers of zilucoplan sodium?
While specific manufacturing partners for zilucoplan are not publicly disclosed, leading peptide synthesis and biologics CMOs like Bachem, Lonza, and Samsung Biologics are probable suppliers given their expertise in GMP-grade peptide production.

2. What challenges exist in sourcing zilucoplan sodium?
Challenges include ensuring supply chain stability for complex peptides, maintaining GMP compliance, manufacturing scale-up from clinical to commercial quantities, and managing costs associated with peptide synthesis.

3. How do regulatory requirements impact suppliers of zilucoplan?
Suppliers must adhere to stringent GMP standards, conduct rigorous quality control, and maintain traceability of raw materials and processes to meet FDA and EMA regulations, which directly influence legitimacy and market access.

4. Are there alternative suppliers or emerging players in zilucoplan's manufacturing?
Emerging biotech firms with novel peptide synthesis technologies may enter the supply chain, offering potential cost and efficiency advantages, though they must meet regulatory standards.

5. How does the manufacturing landscape affect the drug’s commercialization prospects?
A robust, flexible manufacturing infrastructure ensures supply stability, minimizes delays, and supports scale-up, directly impacting price, market competitiveness, and patient access.

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Sources:

1. UCB. Pipeline Overview. UCB.com.
2. Bachem AG. Peptide Manufacturing Capabilities. Bachem.com.
3. Lonza Group. Peptide and Biologics Manufacturing. Lonza.com.
4. Samsung Biologics. Capabilities and Services. Samsungbio.com.