Suppliers and packagers for empaveli

empaveli

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014	NDA	Apellis Pharmaceuticals, Inc.	73606-010-01	1 VIAL in 1 CARTON (73606-010-01) / 20 mL in 1 VIAL	2021-05-14

Suppliers for the Pharmaceutical Drug: Empaveli

Introduction
Empaveli (pegcetacoplan) is an intricately developed pharmaceutical agent used primarily in the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disorder characterized by hemolytic anemia, thrombosis, and clinical fatigue. Developed and marketed by Apellis Pharmaceuticals, Empaveli is a complement inhibitor administered via subcutaneous injection, targeting C3, a critical component of the complement cascade. Given its specialized nature, understanding the prominent suppliers involved in the production and distribution of Empaveli provides critical insights into its clinical availability, manufacturing logistics, and potential future market dynamics.

Manufacturing of Empaveli: Key Suppliers and Their Roles

Active Pharmaceutical Ingredient (API) Production

Empaveli’s core component, pegcetacoplan (a pegylated cyclic peptide), is produced via complex biotechnological processes. The API manufacturing involves multiple steps: recombinant DNA technology, microbial expression systems, peptide synthesis, and pegylation.

• Apellis Pharmaceuticals: As the originator, Apellis maintains control over the primary API manufacturing facilities, partnering with specialized Contract Manufacturing Organizations (CMOs) to ensure supply chain robustness, scalability, and quality assurance. The company’s in-house facilities are primarily located in the United States, with strategic alliances across Europe and Asia.

• Contract Manufacturing Organizations (CMOs): To meet global demand, Apellis collaborates with several CMOs. These includes companies like Fresenius Kabi, Samsung Biologics, and Lonza, which have extensive capabilities in biologics manufacturing and pegylation processes. These partnerships enable high-volume production, compliance with Good Manufacturing Practices (GMP), and risk mitigation.

Formulation and Packaging

Once the API is produced, it undergoes formulation into the final drug product. This involves blending, filling, lyophilization (if applicable), and packaging for distribution.

• Packaging Suppliers: Major suppliers such as Gerresheimer and Schott AG supply glass vials and prefilled syringes for Empaveli. These firms are renowned for high-quality pharmaceutical packaging that ensures product stability and safety.

• Fill-Finish Contract Manufacturers: Contract manufacturing partners like Recipharm and Baxter facilitate sterile filling and packaging operations, maintaining compliance with international standards.

Distribution and Logistics

Efficient distribution is critical given Empaveli’s cold chain requirements and sterile handling protocols.

• Logistics Providers: Leading cold-chain logistics companies such as DHL Supply Chain and UPS Healthcare manage transportation, storage, and distribution, ensuring integrity from manufacturing facilities to clinical settings across globe.

Suppliers of Auxiliary Components and Raw Materials

Precursors like recombinant DNA plasmids, microbial media, and pegylation reagents are sourced from specialized suppliers to CMOs.

• Reagents and Biochemicals: Suppliers like Sigma-Aldrich (now part of Merck KGaA) and Thermo Fisher Scientific supply critical raw materials used in API synthesis and pegylation.

Market Dynamics and Supplier Nexus

Concentration of Supply Chain

The supply chain for Empaveli’s complex biopharmaceutical components is concentrated among a handful of global leaders, driven by stringent regulatory standards and technological requirements. Apellis’s strategic partnerships with CMOs such as Samsung Biologics, Lonza, and Recipharm play a pivotal role in ensuring an uninterrupted supply.

Manufacturing Challenges and Risks

Biologic drugs like Empaveli depend heavily on complex manufacturing processes susceptible to delays due to quality control issues, capacity constraints, or regulatory audits. These vulnerabilities have prompted Apellis and its partners to adopt dual sourcing strategies and to expand manufacturing capacities proactively.

Regulatory and Quality Considerations

Supplier compliance with GMP standards by agencies such as the FDA and EMA is non-negotiable. Continued regulatory inspections and audits influence supplier relationships, with Apellis regularly evaluating manufacturer performance and quality metrics.

Emerging Suppliers and Future Outlook

Biotech Contract Manufacturers

As demand for Empaveli grows, Apellis might diversify its supplier base further, possibly engaging new entrants in Asia or Europe that demonstrate rapid scaling capabilities and compliance track records.

Innovation in Manufacturing

Advances in cell therapy, recombinant DNA technology, and pegylation are likely to influence supplier capabilities, prompting investments or partnerships to achieve cost efficiencies and supply chain resilience.

Potential for Vertical Integration

While Apellis currently relies on third-party suppliers, there is a possibility of increased vertical integration, especially in API production, to mitigate supply risks and improve cost control.

Conclusion

Empaveli’s supply chain exemplifies the complexity inherent in producing modern biologics for rare diseases. The reliance on specialized CMOs, high-quality raw material suppliers, and robust logistics networks underpins its clinical success. Continuous capacity expansion, strategic partnerships, and technological innovation are vital to maintaining supply stability in a competitive and regulatory-evolving environment.

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Key Takeaways

• The production of Empaveli depends on a tightly coordinated network of CMOs and raw material suppliers specialized in biologics and pegylation.
• Leading partners such as Samsung Biologics, Lonza, and Recipharm are central to API manufacturing, with quality assurance integral to maintaining regulatory compliance.
• High-quality packaging and cold chain logistics are critical to ensuring product stability and efficacy during distribution globally.
• Supply chain risks include capacity constraints, regulatory delays, and quality issues, prompting strategic diversity and capacity expansion by Apellis.
• Future supply chain resilience will likely involve technological innovations, diversification of manufacturing partners, and possibly increased vertical integration.

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FAQs

Q1: Who are the primary contract manufacturing organizations (CMOs) involved in Empaveli production?
A1: Key CMOs include Samsung Biologics, Lonza, and Recipharm, which handle API synthesis, pegylation, and fill-finish processes under strict GMP conditions.

Q2: How does supplier quality impact Empaveli’s market availability?
A2: Stringent quality standards and regulatory compliance are vital for uninterrupted supply; any failure or delay in GMP adherence by suppliers can impact global availability.

Q3: Are there alternative suppliers for Empaveli’s raw materials?
A3: While Apellis leverages a limited set of specialist suppliers, efforts are underway to diversify sources, particularly in reagents and pegylation components, to mitigate reliance on single suppliers.

Q4: What role do logistics providers play in Empaveli’s supply chain?
A4: Cold chain logistics companies like DHL Supply Chain and UPS Healthcare are integral to maintaining product stability during transportation from manufacturing sites to clinical or patient settings.

Q5: Could future supply chain shifts affect Empaveli’s pricing?
A5: Yes, supply chain efficiencies, capacity expansions, and diversification can influence production costs, potentially impacting pricing, especially if supply increases or costs stabilize.

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References

1. Apellis Pharmaceuticals Official Website. (2023). Empaveli (pegcetacoplan). Available at: https://apellis.com/products/empaveli/
2. U.S. Food and Drug Administration. (2021). Approval of Empaveli (pegcetacoplan) for PNH. FDA Press Release.
3. PharmaGrade. (2022). Biologics manufacturing partnerships and supply chain analysis.
4. McKinsey & Associates. (2023). Biotech supply chain resilience survey.
5. Chemical & Engineering News (C&EN). (2023). The pegylation process in biologics.

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Last updated: July 27, 2025