Suppliers and packagers for SYFOVRE

SYFOVRE

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	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171	NDA	Apellis Pharmaceuticals, Inc.	73606-020-01	1 VIAL, GLASS in 1 CARTON (73606-020-01) / 3 mL in 1 VIAL, GLASS	2023-02-17
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171	NDA	Apellis Pharmaceuticals, Inc.	73606-020-02	1 VIAL, GLASS in 1 CARTON (73606-020-02) / 3 mL in 1 VIAL, GLASS	2023-02-17
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171	NDA	Apellis Pharmaceuticals, Inc.	73606-020-11	1 VIAL, GLASS in 1 CARTON (73606-020-11) / 3 mL in 1 VIAL, GLASS	2023-02-17
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171	NDA	Apellis Pharmaceuticals, Inc.	73606-020-12	1 VIAL, GLASS in 1 CARTON (73606-020-12) / 3 mL in 1 VIAL, GLASS	2023-02-17

Suppliers for the Pharmaceutical Drug: Syfovre

Last updated: August 2, 2025

Introduction

Syfovre (pegcetacoplan) is a groundbreaking pharmaceutical primarily approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As a complement C3 inhibitor, Syfovre offers a targeted approach to a progressive and currently incurable condition, gaining significant interest within ophthalmology and pharmaceutical sectors. Given its novel mechanism, supply chain robustness is crucial for ensuring patient access and commercial success. This article explores the key suppliers involved in the manufacturing and distribution of Syfovre, examining the drug’s supply chain, manufacturing partners, raw material providers, and distribution channels.

Overview of Syfovre and its Manufacturing Landscape

Syfovre was developed by Apellis Pharmaceuticals, a specialty biopharmaceutical company focused on complement immunotherapy. Its approval by the U.S. Food and Drug Administration (FDA) in 2023 marked a milestone, positioning the drug as a leading treatment option for GA. Pharmacologically, the drug comprises pegcetacoplan, a PEGylated peptide that inhibits complement component C3, thereby reducing inflammation and tissue damage in AMD patients.

Manufacturing of Biologic Drugs

Given that Syfovre is a biologic, its production involves complex biopharmaceutical manufacturing processes. It requires highly specialized facilities capable of producing, purifying, and validating large protein molecules. Such facilities must adhere to stringent regulatory standards, notably current Good Manufacturing Practice (cGMP) compliance.

Key Suppliers in Syfovre’s Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

The core ingredient of Syfovre is pegcetacoplan, a PEGylated peptide produced through recombinant DNA technology. As a proprietary molecule, Apellis Pharmaceuticals oversees initial synthesis; however, it relies on specialized API suppliers for bulk production and raw materials:

• Biocompatible PEG Derivatization Suppliers: PEGylation involves attaching polyethylene glycol (PEG) molecules to peptides to enhance stability and pharmacokinetics. Leading suppliers in PEG derivatives include MEGGLE (part of the Cable Group), NOF Corporation, and Laysan Bio. These suppliers produce pharmaceutical-grade PEGs that meet strict purity standards.

• Recombinant Protein Expression Systems:
  The synthesis of pegcetacoplan involves cell culture systems—often Chinese Hamster Ovary (CHO) cells or other mammalian expression systems. Contract manufacturing organizations (CMOs) such as Samsung Biologics, Boehringer Ingelheim, or Lonza may be engaged to supply or produce the recombinant protein components.

2. Fill-Finish and Packaging Suppliers

Biologics require delicate fill-finish processes in sterile environments, which are often contracted out to specialized CMOs:

• Fill-Finish Contract Manufacturers:
  Companies like Belfast-based The Binding Site, Jubilant HollisterStier, and Recipharm are prominent in biologic fill-finish operations. They ensure the final drug vials are sterile and compliant with regulatory standards.

• Device and Packaging Suppliers:
  The syringes, vials, and packaging materials are supplied by firms such as Gerresheimer, Nipro, and Stevanato Group.

3. Raw Material Providers

The manufacturing of biologics like Syfovre depends heavily on high-quality raw materials, including:

• Cell Culture Media:
  Suppliers like Thermo Fisher Scientific and GE Healthcare provide media necessary for cell growth during manufacturing.

• Chromatography Resins and Purification Media:
  To ensure purity, chromatography resins from Cytiva (formerly GE Healthcare Life Sciences) are essential components in purification processes.

4. Distribution and Logistics Partners

Effective distribution is critical for maintaining drug efficacy, especially given the cold-chain requirements necessary for biologics:

• Cold Chain Logistics Providers:
  Companies such as FedEx Climate Delivers, DHL Good Distribution Practice (GDP) Certified Carriers, and UPS Healthcare facilitate global distribution, ensuring temperature-sensitive transport from manufacturing facilities to healthcare providers.

• Wholesalers and Distributors:
  Regional distributors and specialty pharmacies contract with Apellis Pharmaceutical to supply Syfovre to ophthalmologists and clinics.

5. Regulatory and Certification Vendors

Manufacturing and distribution entities must meet regulatory requirements, with suppliers such as SGS and Intertek providing quality assurance, testing, and certification services.

Supply Chain Challenges and Considerations

Supply Security

Given the complex manufacturing process for Syfovre's biologic, supply chain disruptions could impact drug availability. Dependence on few specialized suppliers for key raw materials and manufacturing capacity constrains flexibility.

Regulatory Compliance

Manufacturers and suppliers must maintain compliance with international standards, including FDA cGMP, EMA Good Clinical Practice (GCP), and ISO certifications, to prevent delays and ensure quality.

Global Expansion and Supply

Expanding distribution beyond North America involves navigating regional regulatory pathways, localized supply chain logistics, and regional manufacturing partnerships to meet demand effectively.

Future Outlook

Strategic collaborations and increased capacity from existing suppliers could enhance supply stability for Syfovre. Apellis Pharmaceuticals’ recent partnerships with CMOs like Samsung Bioepis and others reflect a proactive approach to scaling production. As global demand rises, diversifying supplier bases and investing in flexible manufacturing infrastructure will be vital.

Key Takeaways

• Specialized Suppliers: The supply chain for Syfovre involves high-precision raw material providers, CMOs for manufacturing, and logistics entities with cold-chain capabilities.
• Biologics Manufacturing Complexity: Given the peptide-based, PEGylated nature, production requires sophisticated facilities and compliant raw material sources, predominantly from established providers such as Thermo Fisher Scientific and Cytiva.
• Supply Chain Resilience: Maintaining diversified supplier relationships and investing in manufacturing capacity expansion are essential to mitigate production risks.
• Regulatory Alignment: Suppliers must adhere to stringent international quality and safety standards, ensuring uninterrupted supply and compliance.
• Global Distribution: Strategic logistics partnerships are crucial for timely delivery, especially to regions with varying regulatory landscapes and logistical infrastructure.

FAQs

1. Who are the primary manufacturers of Syfovre's active ingredient?
While Apellis internally develops pegcetacoplan, they may contract with CMOs like Samsung Bioepis or Lonza for large-scale recombinant protein production, leveraging their expertise in biologic manufacturing.

2. What raw materials are critical in Syfovre’s production?
High-purity PEG derivatives, cell culture media, chromatography resins, and sterile purification components are essential raw materials supplied mainly by Thermo Fisher Scientific, Cytiva, and other specialized providers.

3. How is the cold chain maintained during Syfovre distribution?
Third-party logistics providers such as FedEx and DHL, equipped with temperature-controlled containers, ensure that Syfovre remains stable during transit, preserving efficacy until reaching healthcare facilities.

4. Are there any notable suppliers involved in packaging Syfovre?
Yes, firms such as Gerresheimer and Stevanato Group supply sterile vials and specialized packaging components tailored for biologic drugs.

5. What are the key challenges in the supply chain for Syfovre?
Complex manufacturing processes, dependence on specialized raw material suppliers, potential capacity constraints, and regulatory compliance pose ongoing challenges for consistent supply.

Sources

[1] Apellis Pharmaceuticals. Syfovre (pegcetacoplan). Official product information.
[2] U.S. Food and Drug Administration. Syfovre Approval Letter. 2023.
[3] Cytiva. Chromatography Resins for Biopharmaceutical Production.
[4] Thermo Fisher Scientific. Cell Culture Media and Raw Materials.
[5] DHL Supply Chain. Cold Chain Logistics in Biologics.