GMP radiopharmaceuticals for molecular diagnostics: PET tracers, Formula magistralis and dangerous goods transport Class 7
SWAN Isotopen AG
Bern (3010), SwitzerlandNew on Amplifa
About SWAN Isotopen AG
SWAN Isotopen AG is a certified radiopharmaceutical company located on the campus of Inselspital (Bern University Hospital). The company operates a professional, commercial radiopharmaceutical production facility and manufactures GMP radiopharmaceuticals for molecular diagnostics, including PET tracers such as FDG (Flu-SWAN), SWAN-PSMA-1007, SWAN-Choline and Neuraceq (Florbetaben 18F) as well as preparations under Formula magistralis with gallium-68 and lutetium-177. The products are manufactured in accordance with international GMP guidelines and distributed in accordance with GDP standards; distribution is to nuclear medicine centres in Switzerland. The main fields of application are oncology (tumour diagnostics and therapy monitoring) and neurology (e.g. amyloid imaging in Alzheimer's work-up). As one of only a few companies in Switzerland and the only one in the Espace Mittelland region, SWAN also offers a transport service for radioactive materials (dangerous goods class 7) as well as external dangerous goods safety advisory services. In collaboration with the University of Bern (radiochemistry and high-energy physics), the company develops targeted radiopharmaceuticals.
- Site
- Bern
- Processes
- GMP radiopharmaceutical production ([18F]-Fludeoxyglucose, Flu-SWAN, 185 MBq/ml), GMP radiopharmaceutical production ([18F]PSMA-1007, SWAN-PSMA-1007, 222 MBq/ml), GMP radiopharmaceutical production ([18F]-Fluoromethylcholine, SWAN-Choline, 222 MBq/ml), Radiodiagnostic Florbetaben (18F), Neuraceq, 300 MBq/ml, Manufacture of radiopharmaceuticals under Formula magistralis (Gallium-68), Manufacture of radiopharmaceuticals under Formula magistralis (Lutetium-177), Transport service for radioactive materials / dangerous goods transport Class 7 /, Dangerous goods safety adviser Class 7 (external handling of transports of radioactive substances)
- Materials
- [18F]-Fludeoxyglucose (FDG), [18F]PSMA-1007, [18F]-Fluoromethylcholine, Florbetaben (18F), Gallium-68, Lutetium-177, Fluorine-18, Fluorine-18 ([18F]-Fludeoxyglucose, [18F]PSMA-1007, [18F]-Fluoromethylcholine)
- Certificates
- GMP (Good Manufacturing Practices), GDP (Good Distribution Practices)
- Founded
- 2007
- Employees
- 40
- Industries
- Nuclear medicine, Radiopharmacy, Oncology, Neurology, Pharmaceutical manufacturing
- 01
Cyclotron-based radionuclide production
- 02
Radiopharmaceutical synthesis under GMP
- 03
Quality control and release
- 04
Distribution in accordance with GDP
- 05
Transport service for radioactive materials (Class 7)
Products and Radionuclides
Fluorine-18 ([18F]-Fludeoxyglucose, [18F]PSMA-1007, [18F]-Fluoromethylcholine)
Tracer isotope for PET diagnostics in oncology and neurology, calibrated at 185–300 MBq/ml.
Gallium-68
Radionuclide for the manufacture of radiopharmaceuticals under Formula magistralis.
Lutetium-177
Radionuclide for the manufacture of radiopharmaceuticals under Formula magistralis.
Locations
Bern (Inselspital Campus)
CHProduction site and headquarters
- Lot size
- 1 ml to 10 ml vials (222–2222 MBq per vial for SWAN-PSMA-1007)
- Materials
- Fluorine-18, Gallium-68, Lutetium-177
- Cyclotron
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| GMP radiopharmaceutical production ([18F]-Fludeoxyglucose, Flu-SWAN, 185 MBq/ml)Plastics | – | – | – | – | [18F]-Fludeoxyglucose, Sodium chloride, Ethanol 0.5% |
| GMP radiopharmaceutical production ([18F]PSMA-1007, SWAN-PSMA-1007, 222 MBq/ml)Plastics | – | – | – | 1 ml – 10 ml (222–2222 MBq per vial | [18F]PSMA-1007 |
| GMP radiopharmaceutical production ([18F]-Fluoromethylcholine, SWAN-Choline, 222 MBq/ml)Plastics | – | – | – | – | [18F]-Fluoromethylcholine, Sodium chloride, Water for injection |
| Radiodiagnostic Florbetaben (18F), Neuraceq, 300 MBq/mlPlastics | – | – | – | – | Florbetaben (18F) |
| Manufacture of radiopharmaceuticals under Formula magistralis (Gallium-68)Plastics | – | – | – | – | Gallium-68 (Ga-68) |
| Manufacture of radiopharmaceuticals under Formula magistralis (Lutetium-177)Plastics | – | – | – | – | Lutetium-177 (Lu-177) |
| Transport service for radioactive materials / dangerous goods transport Class 7 /Engineering | – | – | – | – | radioactive materials |
| Dangerous goods safety adviser Class 7 (external handling of transports of radioactive substances)Engineering | – | – | – | – | – |
| Development of targeted radiopharmaceuticals (with University of Bern, radiochemistry andEngineering | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Cyclotron | – | – | – | – | Inselspital Campus, Freiburgstrasse 38, Bern |
Additional services
Reference customers
Quality and Certification
The products are manufactured in accordance with international GMP guidelines (Good Manufacturing Practices); distribution is carried out in accordance with international GDP standards (Good Distribution Practices). Swissmedic (SMC) marketing authorisation numbers exist, among others, for Flu-SWAN (61546), SWAN-PSMA-1007 (67370), SWAN-Choline (66087) and Neuraceq (66210).
| Evidence | Bern (Inselspital Campus) |
|---|---|
| GMP (Good Manufacturing Practices) | |
| GDP (Good Distribution Practices) |
History
- 2006
Konrade von Bremen takes over the concept development of the initial project idea
- 2007
Founding of SWAN Isotopen AG in Bern
- 2026
Leadership change: Peter Huggler (CFO) and Giovanni Roncolato (COO) become Co-Managing Directors as of 1 October 2026; Dr. Konrade von Bremen retires after 20 years
- 2026
Founding member of the association "Nuclear Medicine Switzerland"