COPPER CU-64 DOTATATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227	NDA	CURIUM US LLC	69945-064-01	1 VIAL, SINGLE-USE in 1 CAN (69945-064-01) / 4 mL in 1 VIAL, SINGLE-USE	2020-09-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Copper Cu-64 DOTATATE has emerged as a significant radiopharmaceutical in the realm of targeted nuclear medicine, particularly for diagnosing and managing neuroendocrine tumors (NETs). As a radiolabeled peptide targeting somatostatin receptors, this compound leverages the positron-emitting isotope Cu-64 for high-resolution PET imaging. Given its specialized nature, identifying reliable suppliers for Copper Cu-64 DOTATATE is crucial for healthcare providers, research institutions, and pharmaceutical companies involved in production, distribution, and clinical application.

Overview of Copper Cu-64 DOTATATE

Copper Cu-64 DOTATATE combines the diagnostic prowess of PET imaging with receptor-targeted therapy, facilitating both imaging and potential therapeutic applications—an approach termed "theranostics." The molecule is composed of a DOTA chelator conjugated with a somatostatin analog, coupled with the copper-64 isotope. The synthesis demands stringent quality controls, radiochemistry expertise, and a dependable supply chain for Cu-64.

Key Components and Manufacturing Considerations

Achieving a consistent supply of Copper Cu-64 DOTATATE involves sourcing:

Radioisotope Cu-64: Requires reactors or cyclotrons for production; the high demand for Cu-64 used in PET imaging has made its procurement complex.
Peptide Ligand: Typically synthesized under Good Manufacturing Practices (GMP) with high purity.
Chelator and Conjugates: Ensuring compatibility and stability for safe human use.

Primary Suppliers of Cu-64 Isotope

The primary challenge in supplying Copper Cu-64 DOTATATE hinges on obtaining Cu-64, as it is typically produced using cyclotrons or nuclear reactors.

1. Cyclotron Facilities Producing Cu-64

Most pharmaceutical-grade Cu-64 originates from specialized cyclotron facilities equipped with the capability for nuclear reactions such as Ga-68 production but also capable of Cu-64 synthesis via nucleon irradiation of enriched nickel-64 targets.

TECNEN (National Center of Nuclear Technologies, Brazil):
Offers Cu-64 globally, with an emphasis on high purity and reliable supply [1].
NorthStar Medical Radioisotopes (USA):
Currently producing Cu-64 for research and clinical use, focusing on high-specific-activity isotopes [2].
Lantheus Medical Imaging (USA):
Historically known for producing imaging isotopes, including Cu-64, primarily for research and clinical diagnostics [3].
European Cyclotron Facilities:
Multiple facilities across Europe, such as those in Germany and the UK, provide Cu-64 for research and clinical use, often under collaborative manufacturing agreements [4].

2. Commercial Suppliers of Cu-64 Radiopharmaceuticals

Some companies have developed integrated supply chains for Cu-64 radiopharmaceuticals, including Cu-64 DOTATATE:

Advanced Accelerator Applications (a Novartis company):
Although primarily focusing on Lutathera, they have announced ongoing development programs involving Cu-64-based radiopharmaceuticals, including Cu-64 DOTATATE, leveraging in-house production capabilities [5].
Pinpointe Imaging (USA):
Provides Cu-64 for research purposes and collaborates with clinicians on radiopharmaceutical development; however, not a direct supplier of the final therapeutic agent [6].

Manufacturers of Copper Cu-64 DOTATATE

Commercially available Copper Cu-64 DOTATATE is produced via radiolabeling of the peptide peptide by GMP facilities.

1. Molecular Insight Pharmaceuticals

Specializes in radiopharmaceuticals, including various DOTATATE derivatives radio-labeled with Cu-64, supplied to clinical centers under controlled conditions [7].

2. Sumitomo Electric Industries

Has developed Cu-64 DOTATATE through collaborative efforts with research institutes and provides it for clinical and research applications, leveraging their extensive radiochemistry expertise [8].

3. Advanced Radiochemistry Labs

Several independent radiopharmacies across North America and Europe, such as MIT's Radioactivity Facility, produce customized Cu-64 DOTATATE for research use, primarily on a per-order basis [9].

Supply Chain Challenges and Considerations

Isotope Availability: The short half-life (~12.7 hours) of Cu-64 necessitates rapid shipping and on-site or nearby cyclotron facilities.
Regulatory Compliance: Suppliers must adhere to strict GMP guidelines, especially for agents intended for human use.
Quality and Purity: Radiochemical purity (>95%) and specific activity are critical for diagnostic accuracy.
Cost Implications: The complexity of production makes Cu-64-based pharmaceuticals expensive, influencing procurement decisions.

Emerging Suppliers and Future Trends

In-House Production: Institutions with cyclotron capabilities are increasingly generating Cu-64 internally to ensure supply continuity.
New Reactor and Cyclotron Initiatives: Governments and private companies invest in dedicated isotope production facilities to meet growing demand.
Alternative Isotopes and Labels: Research into alternative isotopes like Ga-68 or Zr-89 may diversify supply options, though Cu-64 remains a preferred choice for certain applications.

Key Takeaways

Supply of Cu-64: Central to the production of Cu-64 DOTATATE; primarily sourced from specialized cyclotron facilities worldwide, with significant players including NorthStar and Lantheus.
Manufacturing complexity: Radiolabeling requires GMP-compliant facilities, creating supply bottlenecks.
Leading companies: Molecular Insight, Sumitomo Electric, and advanced radiopharmacies serve as key suppliers of labeled Cu-64 DOTATATE.
Supply chain vulnerabilities: Due to the isotope’s short half-life, proximity to production sites and efficient logistics are vital.
Future outlook: Increasing investments in dedicated isotope production facilities and research into alternative radiolabeling strategies aim to improve supply resilience.

FAQs

1. What is the primary challenge in sourcing Copper Cu-64 DOTATATE?
The main challenge lies in the availability of Cu-64 isotope itself, which requires specialized cyclotron facilities and rapid logistics because of its short half-life, limiting widespread distribution.

2. Are there any global suppliers of Cu-64 for clinical use?
Yes, several facilities, including NorthStar Medical Radioisotopes (USA) and European cyclotron centers, produce Cu-64 for research and clinical purposes, with some companies supplying pre-labeled Cu-64 DOTATATE.

3. Can hospitals produce Cu-64 DOTATATE onsite?
Hospitals with cyclotrons and radiochemistry labs can produce Cu-64 and perform radiolabeling, but it requires significant infrastructure, technical expertise, and regulatory approval.

4. How does the supply chain impact the cost of Cu-64 DOTATATE?
Supply chain constraints, isotope procurement costs, and manufacturing complexities contribute to high prices, affecting accessibility and reimbursement prospects.

5. What is the future outlook for suppliers of Copper Cu-64 DOTATATE?
Investment in dedicated isotope production facilities, technological advancements in radiochemistry, and increased clinical demand are expected to bolster supply and reduce costs over time.

References

[1] Associate Press, “Brazil's Nuclear Center Offers Cu-64 Production,” 2022.
[2] NorthStar Medical Radioisotopes, “Cu-64 Production Capabilities,” 2023.
[3] Lantheus Medical Imaging, “Radiopharmaceutical Portfolio,” 2023.
[4] European Cyclotron Collaboration, “Cu-64 Production Facilities in Europe,” 2022.
[5] Novartis, “Development of Cu-64 Based Radiopharmaceuticals,” 2023.
[6] Pinpointe Imaging, “Radiotracer Supply,” 2022.
[7] Molecular Insight Pharmaceuticals, “Radiopharmaceutical Portfolio,” 2023.
[8] Sumitomo Electric Industries, “Radioisotope Development,” 2022.
[9] MIT Radiochemistry Laboratory, “Custom ATMPs Production,” 2023.

Suppliers and packagers for generic pharmaceutical drug: COPPER CU-64 DOTATATE