Our core competencies are:
- GMP contract manufacturing of radiopharmaceuticals
- Development, optimization and validation of production lines for radiopharmaceuticals
- Contract testing of radiopharmaceuticals and starting materials for radiopharmaceuticals
As pure radiopharmaceutical CDMO (Contract Development and Manufacturing Organization) we offer all services related to radiopharmaceuticals from initial method development, early supply for clinical trials up to late commercial supply.
As independent contract manufacturer discretion as well as transparency for each and every customer are fundamental values for us. Also, as part of our pure CDMO philosophy we are not holding any marketing authorizations or intellectual properties related to radiopharmaceuticals.
GMP Contract manufacturing
Our main business is the routine Contract manufacturing of various parenteral radiopharmaceuticals under aseptic conditions in accordance with GMP regulations for human use. We are supplying radiopharmaceuticals throughout their complete product lifetime starting with pre-clinical studies and clinical trials until commercial supply.
Our in-house include not only production and complete quality but also batch release, stability testing and handling of orders and managing of transport logistics. Upon customer request we can cover all services related to the supply of radiopharmaceuticals from ordering to delivery. For shipments to clinical sites we use an extensive network of subcontracted external and qualified couriers.
For several ongoing clinical trials we offer our services as central EU radiopharmacy.
Our activities are focused on radiopharmaceuticals containing the following radionuclides:
Moreover, we are currently working on an extension of our radiation protection license for handling radiopharmaceuticals containing alpha emitting radionuclides, especially Actinium-225 (Ac-225).
For the purpose of developing, optimizing and validating of methods we are also working with the radionuclides Technetium-99m (Tc-99m) and Gallium-68 (Ga-68).
Besides the radionuclides mentioned above we also have handling licenses for handling of other radionuclides available upon customer request.
Most of the radiopharmaceuticals produced at our site are used within Europe. Therefore managing of transport logistics within the European Union and Switzerland are our daily business. Besides this we also have experience with internal transports to clinical sites in USA, South Africa and Australia.
We work with external transport companies to organize the reliable, rapid and on-time delivery of radiopharmaceuticals.
Decades of Experience
The business unit Pharmaceuticals of Seibersdorf Laboratories is a pure and independent radiopharmaceutical CDMO (Contract Development and Manufacturing Organization). Our production plant is one of the longest-standing and largest radiopharmaceutical manufacturing plants in Central Europe. Radiopharmaceuticals have been commercially manufactured at Seibersdorf for decades. Besides our experience customers also value our high flexibility and short reaction times.
Through consistent compliance with the highest quality standards, both in production and quality control, we have been ensuring the safety of patients and users for many years. Our highly experienced, qualified and motivated team is a crucial part of our success.