LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833	NDA	Advanced Accelerator Applications USA, Inc	69488-010-61	1 VIAL, GLASS in 1 PACKAGE (69488-010-61) / 7.5 mL in 1 VIAL, GLASS	2022-03-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Lutetium Lu-177 VIPIVOTIDE Tetraxetan is an innovative radiopharmaceutical primarily used in targeted cancer therapy, particularly for treating neuroendocrine tumors. As a specialized therapeutic agent, its manufacturing, distribution, and supply chain involve highly regulated processes governed by nuclear medicine standards. This article provides a detailed overview of the key suppliers involved in the production and distribution of Lutetium Lu-177 VIPIVOTIDE Tetraxetan, highlighting their roles, capabilities, and market significance.

Overview of Lutetium Lu-177 VIPIVOTIDE Tetraxetan

Lutetium Lu-177 VIPIVOTIDE Tetraxetan is a peptide-based radioligand linked to the radionuclide Lutetium-177 ($^{177}$Lu). It targets specific receptor sites on tumor cells, delivering localized radiation therapy that minimizes damage to surrounding healthy tissue. Its efficacy depends on advanced production techniques, high-quality radiochemical synthesis, and reliable distribution channels, making suppliers’ roles critical in ensuring consistent drug availability.

Manufacturers and Supply Chain Players

1. Radioisotope Production Suppliers

The foundation of Lutetium Lu-177 VIPIVOTIDE Tetraxetan's supply chain is the production of Lutetium-177 itself. Its availability hinges on nuclear reactors or particle accelerators capable of producing high-purity $^{177}$Lu.

IONIS Pharmaceuticals / Sophisticated Nuclear Reactor Operators
Historically, $^{177}$Lu has been produced via reactor irradiation of ytterbium-176 targets, mainly at facilities with the capacity for high-flux neutron irradiation and subsequent radiochemical processing. Leading suppliers include institutions operating in the United States (e.g., Oak Ridge National Laboratory), Europe (e.g., the Bruyères-le-Châtel facility in France), and Australia (e.g., ANSTO).
Key Attributes:
- High radiochemical purity (>99%)
- Availability of bulk irradiated targets
- Reliable supply chains capable of meeting global demand
Commercial Suppliers for $^{177}$Lu
Several commercial entities have emerged to commercialize $^{177}$Lu, including:
- ITM Isotopen Technologien München (ITM) — A prominent European producer supplying high-quality $^{177}$Lu for theranostic applications.
- Curium Pharma (partnered with IRE) in the US — Provides $^{177}$Lu as part of its radiopharmaceutical offerings.
- NTP Radioisotopes (South Africa) — Offers ^177Lu derived from MOX (Mixed Oxide) fuel reprocessing, emphasizing sustainable supply.

2. Peptide Synthesis and Conjugation

Beyond the radionuclide, the non-radioactive peptide VIPIVOTIDE requires synthesis with high purity and precise conjugation to the tetraketans (chelator molecules) that facilitate stable radiometal binding.

Specialized Biotech and Biopharma Manufacturers
Companies specializing in peptide synthesis and bioconjugation include:
- Peptide specialty firms like PolyPeptide Group and Thermo Fisher Scientific — Capable of synthesizing complex peptide sequences under GMP conditions.
- Custom bioconjugation service providers — Offering tethering of peptides to chelators in tailored manufacturing runs.

3. Radiolabeling and Final Product Manufacturing

The process of attaching $^{177}$Lu to the VIPIVOTIDE peptide involves specialized radiolabeling facilities compliant with nuclear regulatory standards. These facilities often belong to:

Pharmaceutical companies with radiopharmaceutical manufacturing capabilities
- Advanced Medical Isotope (AMI) — Developed radiopharmaceuticals in partnership with academic and industrial partners.
- Eckert & Ziegler — A leading global provider of radioisotope products and radiopharmaceutical services, including customized radiolabeling.
Third-party Contract Manufacturing Organizations (CMOs)
- Utilize GMP-compliant radiolabeling units ensuring batch consistency and regulatory compliance.

4. Distribution and Logistics

The short half-life (6.7 days) of $^{177}$Lu imposes logistical challenges, necessitating highly coordinated supply routes.

Specialized Radiopharmaceutical Distributors
- BIDMC Radiopharmacy (Boston, USA)
- Medi-Physics (UK-based)
- GRYFFIN RX — Provides tailored distribution solutions across Europe and North America.
- Atomic Energy of Canada Limited (AECL) — Involved in reactor-to-clinic supply chains.

These distributors must ensure timely delivery within radiation safety regulations, often leveraging courier networks with boosted security and compliance procedures.

Emerging and Alternative Suppliers

As demand for Lutetium-based therapies escalates, new entrants are advancing:

Commercial startups like Novartis and Curium are expanding their radiopharmaceutical portfolios.
Academic and governmental reactors are investing in newer, more economical production pathways like reactor-based neutron activation and cyclotron techniques for $^{177}$Lu, which may diversify the supplier landscape.

Regulatory and Quality Considerations

Suppliers must adhere to stringent regulatory standards, including GMP (Good Manufacturing Practice), ISO certifications, and licenses issued by agencies such as the FDA, EMA, and respective national regulatory bodies. The consistency of source material, purity, and radiochemical stability directly impacts product efficacy and safety.

Market Trends and Future Outlook

The global radiopharmaceuticals market, projected to reach over USD 10 billion by 2025, underscores the importance of scalable, reliable supply chains for Lutetium-177 based therapies. Supply constraints and regulatory hurdles remain, but technological advances in cyclotron production and target recycling promise to broaden the supplier base.

Key Takeaways

High-capacity radioisotope manufacturers such as ITM and NTP are central to Lutetium Lu-177 VIPIVOTIDE Tetraxetan supply.
Specialized radiolabeling facilities and GMP-compliant CMOs ensure the final product’s quality and regulatory compliance.
The successful distribution of Lutetium Lu-177 VIPIVOTIDE Tetraxetan depends on efficient logistics capable of handling short-lived isotopes.
Market expansion hinges on advancing alternative production methods, including cyclotron-based $^{177}$Lu, which may diversify supply sources.
Stakeholders should prioritize quality assurance, regulatory adherence, and logistical robustness to mitigate shortages and ensure steady access.

FAQs

1. What are the primary challenges in sourcing Lutetium Lu-177 VIPIVOTIDE Tetraxetan?
Supply shortages due to limited reactor capacity, regulatory hurdles, and logistical complexities stemming from the isotope's short half-life.

2. How do manufacturers ensure the purity of Lutetium-177 used in therapy?
Through rigorous radiochemical processing, quality control testing for radionuclidic purity, and adherence to GMP standards.

3. Are there alternative suppliers for Lutetium-177, and how reliable are they?
Yes, newer suppliers using cyclotron-based methods are emerging. Their reliability depends on scale-up success, regulatory approvals, and technological maturity.

4. What role do distribution logistics play in the availability of Lutetium-based therapies?
Critical, as timely delivery within the isotope’s decay window is essential for maintaining therapeutic efficacy and patient safety.

5. How is the industry planning to address future demand for Lutetium Lu-177 therapies?
By investing in new production facilities, expanding reactor capacity, developing cyclotron methods, and improving supply chain logistics.

References

[1] European Medical Isotope Programme, European Commission (2022). “Supply Chain and Production of Lutetium-177.”
[2] IRE (2008). “Development of $^{177}$Lu Radiopharmaceuticals for Targeted Therapy.”
[3] NTP Radioisotopes (2021). “Global Supply of Medical Isotopes and Future Strategies.”
[4] Eckert & Ziegler (2022). “Radiopharmaceutical Manufacturing Capabilities.”
[5] Market Research Future (2023). “Global Radiopharmaceuticals Market Analysis and Forecast.”

Suppliers and packagers for generic pharmaceutical drug: LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN