Field of Activity

Radiopharmaceuticals

As a leading independent CDMO, we help pharmaceutical companies develop and commercialize new and advanced radiopharmaceuticals.

In Seibersdorf, we operate one of the largest and most renowned radiopharmaceutical production sites in Central Europe, where radiopharmaceuticals have been manufactured commercially under GMP conditions for decades.

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“As an independent CDMO, we support our partners from initial method development through early clinical care to commercial production — as a neutral partner without our own approvals or patents.”

Dr. Kerstin Rumpelmayr
Head of Radiopharmaceuticals
Facts

Personalized radiopharmaceuticals

Our customers benefit from the highest product quality, in-depth regulatory expertise, reliable delivery performance and one of the fastest time-to-market implementations for radiopharmaceuticals in Europe.

50+
Years of
Experience
1200+
Doses
per Year
12 Months
Time-To-
Market
40+
Highly qualified
employees

What we do

Radipharmacaceuticals Entwicklung
Implementation

With our extensive expertise, we offer tailor-made solutions for the development, optimization and validation of production lines for radiopharmaceuticals, which enable efficient and legally compliant manufacturing processes.

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Radipharmacaceuticals Produktion
Production

In six dedicated clean rooms, we produce investigational drugs for clinical trials and commercial radiopharmaceuticals on a daily basis under the strictest GMP standards.

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Radipharmacaceuticals Qualitätskontrolle
Quality Control

Immediately after production, a sample of each batch is handed over for quality control to ensure compliance with all specifications.

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Radiopharmaceuticals Chargenfreigabe
Batch Release

Within just one working day after production, the batch is provisionally approved for use on patients.

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Radipharmacaceuticals Logistik
Logistics

Because of the short half-lives of many radiopharmaceuticals, precise just-in-time delivery is crucial.

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Radiopharmaceuticals

Overview of Services

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Implementation

Our experienced team of radiochemists and process specialists implements several production processes for international sponsors every year. Thanks to our established infrastructure and extensive experience, new products can usually be successfully implemented within 12 months.

Each process implementation includes:

  • Development and optimization of manufacturing processes and quality control processes
  • Scaling and transfer to GMP production
  • comprehensive documentation and regulatory support
  • final process validation

Our team consists of highly qualified specialists, including senior radiochemists with many years of experience in the development and implementation of radiopharmaceutical manufacturing processes.

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Radiopharmaceuticals (Foto: Seibersdorf Labor GmbH)

Production

Our production infrastructure enables reliable, flexible and scalable production of radiopharmaceutical products for clinical trials and commercial applications.

Our radionuclides
We are currently focusing on radiopharmaceuticals that contain these radionuclides:

  • Fluorine-18 (F-18)
  • Lutetium-177 (Lu-177)
  • Actinium-225 (Ac-225)

Interested in other radionuclides? 

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Our services

  • Radio labeling (small molecules peptides and antibodies)
  • wording
  • Aseptic filling
  • packing

Our products

  • Phase 1-3 investigational drugs
  • commercial products

Quality Control

Quality control is carried out in four specialized inhouse testing laboratories. As a result, all analyses of radiopharmaceutical products can be carried out directly on site — quickly, reliably and in accordance with regulatory requirements.

Our testing services include:

Physico-chemical analyses

  • High performance liquid chromatography (HPLC)
  • thin layer chromatography (TLC)
  • gas chromatography (GC)

Microbiological testing

  • Sterility testing (including hot sterility testing)
  • Bacterial endotoxin testing

Thanks to our fully integrated quality control, we can guarantee fast analysis times and the highest quality standards.

Prüfung Arzneimittel (Foto: Seibersdorf Labor GmbH)

Batch Release

Our team of five experienced Qualified Persons (QPs) ensures that each batch meets regulatory requirements and is properly approved.

The approval process comprises:

  • preliminary batch release for timely clinical use
  • final batch release after complete documentation review

In addition, we also offer import batch approvals for the European market. This service can be used as a stand-alone service by external certified manufacturers.

Radiopharmaceuticals (Foto: Seibersdorf Labor GmbH)

Logistics

Our logistics processes are specifically designed to meet the requirements of radiopharmaceutical products. Thanks to our proximity to Vienna-Schwechat Airport and cooperation with experienced international transport partners, we guarantee fast and safe deliveries worldwide.

Our logistics expertise includes:

  • Just-in-time deliveries for time-critical products
  • International transport solutions with specialized and certified logistics companies
  • Refrigerated transport down to minus 60 °C
  • Deliveries to all continents

Customer opinion

“We are very satisfied with the services provided by Seibersdorf Laboratories and highly appreciate the partnership that has been created.

From day one, they have impressed us with exceptional expertise, a high level of care and a high standard of quality.”

Bradley Waldron
VP of CMC and Supply Chain, Blue Earth Therapeutics
Gerik Marina (Foto: Gerik Marina)

Employee opinion

“At Seibersdorf Laboratories, I can take on responsibility, contribute my own ideas and develop myself professionally and personally. To be part of an organization that takes responsibility — for employees, innovation and society. That is exactly what makes my work here special.”

Marina Gerik
Businessdevelopment bei Seibersdorf Laboratories

Employee opinion

“Working at Seibersdorf Laboratories is very rewarding, as we contribute to life-saving progress through the production of radiopharmaceuticals that make a real difference for patients all over the world.”

Tätigkeit
Sachkundige Person bei Seibersdorf Laboratories
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Radiopharmaceuticals

Where you can meet us

RadPharm Symposium

Alzheimer R&D in Microgravity

6. October 2026, Vienna Airport Convention Center

How research in microgravity is yielding new insights for Alzheimer’s diagnosis and treatment—and how these advancements will benefit patients tomorrow.

Join us on our journey!

More about Radpharm Symposium

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Event

EANM 2026

17. - 21. October 2026, Vienna 

EANM brings together nuclear medicine professionals from a range of medical specialties.

Schedule a meeting with our experts to discuss potential partnerships in person.

 

 

 

Schedule a Meeting

Congress

ESRR 2026

16 -19 April 2026, Bergen, Norway

22nd European Symposium on Radiopharmacy and Radiochemistry, organized by the European Society of Radiopharmacy and Radiochemistry.
 

Please contact us to arrange a meeting at ESRR 2026.

 

 

Schedule a Meeting

Your data is safe with us

Data security

We believe that the security of the data we process is a critical process. For this reason, our business unit has been certified according to ISO 27001 and awarded the Cyber Trust Label Platinum for the highest cybersecurity standards.

to the certificate

Open Innovation

Innovation is our motivation

As an innovation partner for interested groups and actors (“stakeholders”) in our ecosystem, we work with experts from SL's internal Innovation Studios on groundbreaking concepts for the radiopharmacy of the future and, in the spirit of open innovation, involve the pharmaceutical industry and clinical users in particular in projects via our InnoBase platform.

Radiopharmaka Neubau

Opening of the New Radiopharmaceuticals Facility in 2027


Facts

  • Laboratory space: 1,300 m²
  • 8 production laboratories 

Suites

Production suites are available for rent. The customer is responsible for providing the equipment. 

Request a Suite now
 

How we support you

We go beyond the traditional role of a manufacturer and support you as a reliable partner through every stage of development - from the initial concept to a successful market launch.

Our focus is on open, collaborative partnerships with clear shared goals. In our CDMO projects, we drive forward forward-thinking solutions that make a lasting contribution to improving patient care and create long-term value - for your company as well as for patients.

Are you looking for a reliable partner for the precise development and GMP-compliant manufacturing of radiopharmaceuticals?

Contact us for more information or a personalized consultation.

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