Commissioned Production

Pharmaceuticals

Commissioned Production

Cyclotron and Synthesis Modules

At our location, we have a GE PETtrace cyclotron which is used to manufacture the radionuclide fluorine-18 (in the form of 18F-fluoride and 18F-fluorine gas) using 16 MeV protons.

The following synthesis modules are currently available for the production of radiopharmaceuticals in accordance with GMP:

  • 3 GE FASTlab synthesis modules
  • 2 Scintomics GRP synthesis modules
  • 1 GE Tracerlab Fx synthesis module
  • 1 Eckert & Ziegler Pharmtracer synthesis module
  • 1 IBA Synthera synthesis module
  • 1 Synthra synthesis module
     

Our facility comprises clean room areas totaling more than 400 m2 with three production rooms for radiopharmaceuticals.

These production rooms are equipped with three dispensing units for the aseptic filling of the various different radiopharmaceuticals.

Our largest production room for the manufacture of 18F-radiopharmaceuticals has a total of nine lead cells.

 

Quality Standards

In the business unit Pharmaceuticals, we have many years of expertise in the area of pharmaceutical production and quality control in accordance with GMP guidelines.

The ultimate goal of our activity is quality. Due to our extensive certifications and accreditations, our work is subject to the permanent control of national and international inspectors.

 

GMP-Certification

  • Production of pharmaceuticals
  • GMP-operating license and BASG certificate in accordance with the EU Directive 2001/83/EC, 2001/20/EC, 2003/94/EC and AMG and AMBO 2009

 

Certification EN ISO 9001 in the current version

 

PET Tracer Alzheimer

In Austria, about 100,000 people already suffer from dementia. Due to demographic trends, the number of people affected will rise to about 230,000 by the year 2050. The majority of these dementias are based on Alzheimer's disease.
 

Tracer for Alzheimer's the diagnosis of Alzheimer’s disease

The business unit Pharmaceuticals of Seibersdorf Labor GmbH provides radioactive drugs (tracers) for the diagnosis of Alzheimer's disease using PET (positron emission tomography). These diagnostic tools are highly likely to predict Alzheimer's disease well before the onset of symptoms.

For many years, the pharmaceutical industry has been researching a drug therapy for Alzheimer's. With tracers made by Pharmaceuticals, which visualize biochemical processes in the living organism, the search for appropriate drugs for therapy will progress more rapidly.

 

Production of Tracers

Our diagnostic tracers use fluorine-18 as a radionuclide, which is manufactured directly at our company site using a cyclotron (GE PETtrace). Due to the half-life of fluorine-18 (110 minutes), the transport of these products is also possible over longer distances.

In cooperation with an external transport company, we organize the reliable, fast and punctual delivery of our products within the European Union and Switzerland.

Our business unit Pharmaceuticals business has many years of experience in the field of radiopharmacy and produces to the highest pharmaceutical quality standards.
 

Our range of products and services

  • Tracer for Alzheimer's diagnosis
  • GMP-compliant contract manufacturing custom production under aseptic conditions
  • Delivery within the EU and Switzerland

 

Your advantages

  • high flexibility
  • short reaction times
  • many years of long-standing experience in drug production
  • and in quality control

 

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