Suppliers and packagers for scenesse

scenesse

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797	NDA	CLINUVEL INC.	73372-0116-1	1 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS	2019-12-31

Last updated: August 8, 2025

ppliers for the Pharmaceutical Drug: SCENESSE

Introduction
SCENESSE (targeted for the treatment of erythropoietic protoporphyria, EPP) is a critical pharmaceutical product developed by Swedish Orphan Biovitrum (Sobi). As an innovative therapy, its production hinges on a complex supply chain, involving multiple specialized suppliers across the globe. Ensuring consistent supply, quality control, and regulatory compliance for SCENESSE requires a detailed understanding of its sourcing framework and supply chain partners.

Active Pharmaceutical Ingredient (API) Suppliers

The core of SCENESSE’s production is its active pharmaceutical ingredient, afamelanotide, a synthetic analogue of alpha-melanocyte stimulating hormone (α-MSH). The API’s quality and purity are pivotal to product efficacy and safety. Sobi, the manufacturer, partners with specialized chemical synthesis firms, primarily based in regions like Europe, North America, and Asia, which are equipped for high-quality peptide synthesis and scale-up.

While Sobi maintains strict control over its API suppliers for confidentiality and quality assurance, publicly available information indicates that afamelanotide is synthesized by multiple contract manufacturing organizations (CMOs) with expertise in peptide manufacturing, such as those in Switzerland, Germany, and the United States. These regions are known for compliance with Good Manufacturing Practice (GMP) standards, critical for pharmaceutical substances.

Formulation Manufacturers

The formulation of SCENESSE involves integrating the API into a biodegradable subdermal implant. The companies responsible for formulation development and manufacturing are typically specialized biotechnology and pharmaceutical firms with experience in implant technology, including biocompatible polymers and drug delivery systems. Sobi collaborates with these formulators to ensure consistency, stability, and bioavailability of the implant.

European, North American, and Asian biotech firms with experience in implantable drug delivery devices are potential formulators. Many of these manufacturers have the necessary GMP certifications and experience handling sensitive biologics such as afamelanotide.

Device Suppliers

The SCENESSE implant device itself is produced by specialized medical device manufacturers. These firms are responsible for fabricating the biodegradable implant carriers that deliver afamelanotide subdermally. The implant’s device components—such as biodegradable polymers like poly(lactic-co-glycolic acid) (PLGA)—are sourced from raw material suppliers with stringent quality standards.

Major global suppliers of biodegradable polymers have facilities in North America, Europe, and Asia, with companies like Evonik, BASF, and Corbion offering high-quality raw materials. Device manufacturing firms typically operate under ISO 13485 standards, ensuring regulatory compliance in Europe and the United States.

Packaging and Cold Chain Logistics

Given the sensitivity of afamelanotide, packaging and cold chain logistics form a crucial part of the supply chain. Packaging suppliers provide tamper-proof, sterile packaging solutions compatible with the implant. Logistics providers with expertise in cold chain management ensure transport under controlled temperature conditions, typically around 2-8°C, across the global distribution network.

Major logistics providers that specialize in temperature-sensitive pharmaceutical distribution, such as DHL Life Sciences, FedEx Custom Critical, and UPS Healthcare, act as critical partners in maintaining the integrity of SCENESSE during transit.

Regulatory and Quality Assurance Partners

Suppliers must adhere to rigorous regulatory standards, including those set by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Typically, Sobi’s supply chain partners are certified with GMP, ISO 13485, and other relevant certifications.

Third-party quality assurance organizations conduct audits and inspections of suppliers, ensuring compliance and consistent quality across the supply chain. This network maintains SCENESSE’s high standards, addressing the complexity of peptide synthesis, device manufacturing, and raw material procurement.

Key Challenges and Strategic Sourcing Considerations

Global supply chains for complex biologics like SCENESSE are vulnerable to disruptions from geopolitical tensions, raw material shortages, and logistical constraints. Sobi mitigates these risks by diversifying its supplier base, engaging multiple qualified manufacturers for key components, and maintaining buffer stock where feasible.

Furthermore, sourcing from regions with robust regulatory environments and established GMP manufacturing capabilities ensures compliance and reduces approval hurdles. The importance of integrating suppliers with advanced quality systems cannot be overstated to meet global regulatory expectations.

Future Outlook and Evolving Supplier Landscape

As demand for SCENESSE continues to grow, particularly with expanded approvals and indication expansions, Sobi is likely to engage additional suppliers to scale production. The shift toward more sustainable, high-quality raw materials and innovative drug delivery technologies may also influence future supplier selection, emphasizing environmentally responsible materials and advanced manufacturing processes.

Emerging players in peptide synthesis and advanced biomaterials may offer opportunities for strategic partnerships, ensuring resilience and innovation within the supply chain. Increased digitization and supply chain transparency will remain central to maintaining the integrity of this complex ecosystem.

Conclusion

The supply chain for SCENESSE encapsulates a multidisciplinary network of API manufacturers, formulation specialists, device producers, packaging providers, and logistics carriers. Ensuring a steady, high-quality supply involves rigorous qualification processes, adherence to regulatory standards, and strategic diversification to mitigate risks. As the landscape evolves, proactive engagement with innovative suppliers and a focus on supply chain resilience will be critical in supporting the sustained availability of this vital therapy.

Key Takeaways

• SCENESSE’s supply chain hinges on specialized peptide synthesis, device manufacturing, and Cold Chain logistics, each managed by GMP-compliant, globally recognized firms.
• Diversification of suppliers and rigorous quality standards are essential to minimize risks related to raw material disruptions and regulatory hurdles.
• Strategic partnerships with innovative suppliers will be crucial to meet increasing demand and incorporate new technologies in the future.
• Robust logistics, especially temperature-controlled transportation, ensures the integrity of the sensitive implant throughout the distribution process.
• Continuous supplier qualification, compliance audits, and embracing supply chain transparency are vital in maintaining the high standards required for SCENESSE.

FAQs

Q1: Who are the primary API suppliers for SCENESSE?
A1: Sobi sources afamelanotide from multiple contract manufacturing organizations specializing in peptide synthesis, primarily based in Europe and North America, adhering to GMP standards. Specific supplier identities are proprietary, but they possess expertise in peptide and biologic manufacturing.

Q2: What are the main raw material sources for the SCENESSE implant components?
A2: The biodegradable polymers, such as PLGA, are sourced from suppliers like Evonik, BASF, and Corbion, which supply high-quality raw materials suitable for medical device manufacturing under strict quality controls.

Q3: How does Sobi ensure the quality and regulatory compliance of its supply chain?
A3: Through strict qualification processes, regular audits, and certifications such as GMP and ISO 13485, Sobi ensures its suppliers meet high standards. Additionally, third-party inspections and quality assurance protocols uphold compliance.

Q4: What logistics partners are involved in distributing SCENESSE globally?
A4: Leading cold chain logistics providers like DHL Life Sciences, FedEx Custom Critical, and UPS Healthcare facilitate temperature-sensitive transportation, maintaining the integrity of the product during transit.

Q5: Are there any emerging suppliers or technologies that could impact the SCENESSE supply chain?
A5: Yes, advancements in peptide synthesis, biodegradable materials, and device manufacturing by North American, European, and Asian firms are anticipated to enhance supply resilience and innovative drug delivery options in the future.

References

1. Swedish Orphan Biovitrum (Sobi). (2023). SCENESSE (afamelanotide) Prescribing Information.
2. European Medicines Agency (EMA). (2022). Guidelines on Good Manufacturing Practice (GMP).
3. U.S. Food and Drug Administration (FDA). (2022). Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality.
4. Market Reports. (2022). Global Peptide Market and Supply Chain Dynamics.
5. Industry Publications. (2023). Innovations in Biodegradable Polymers for Implantable Devices.