Radiopharmaceutical Bioanalysis
Advanced bioanalytical solutions for radiopharmaceutical drug and therapy development
Radiopharmaceutical Bioanalysis Solutions
For over 15 years, our GMP and GLP-accredited radiopharmaceutical facility in Turku, Finland (registered with the Finnish Radiation and Nuclear Safety Authority – STUK) has been providing radiobiological services including full radioactive sample management, radioimmunoassay method development & validation, clinical sample analysis, and more to advance customers’ radiopharmaceutical drug development.
Adhering strictly to regulatory standards for safety and efficacy, our team is licensed and experienced in handling a variety of key isotopes including Ac-225, Th-227, H-3, I-125, and I-131. We can also work with a wide range of other radioactive substances with expedited approval from Finnish authorities to meet sponsor needs.
Our Radiopharmaceutical Services:
Sample Management
Our facility is fully capable of receiving and storing radioactive samples. Samples are recorded and monitored for total radioactivity.
PK Sample Analysis
Multi-step approach using immunological and cell-based techniques for pharmacokinetic (PK) sample analysis.
Immunogenicity Testing
Plate and cell-based technologies to assess the immunogenicity of biological drugs and vaccines.
Assays & Platforms
Our expert team harnesses various assays and platforms for GMP/PK Analysis and Immunogenicity testing, including:
- ECL (MSD)
- Gyrolab
- ELISA
- SPR (Biacore)
- TR-FIA (Delfia) & TR-FRET
- AlphaScreen/AlphaLISA
- Cell-based assays
- Radioimmunoassays (RIA)
- Wizard2 gammacounters
- LC-MS/MS
Learn More in Our Webinar:
Gammacounting Technology
Combining outstanding sensitivity together with high-level security, connectivity and ease of use, the Wizard2® is Synexa’s gammacounting instrument of choice for radiopharmaceutical bioanalysis.
FAQ
What radiopharmaceutical services does Synexa provide?
We provide radiobiological services including full radioactive sample management, radioimmunoassay method development, validation and preclinical (GLP) & clinical (GCLP) sample analysis.
Which radioisotypes can Synexa work with?
Our team is licensed and experienced in handling a variety of key isotopes, such as Ac-225, Th-227, H-3, In-111, I-125, I-131. We can also work with a wide range of other radioactive substances with expedited (2-3 week) approval from authority to meet sponsor needs.
What regulations does Synexa follow with regard to handling radioactive samples?
Our GLP and GMP-accredited radiopharmaceutical facility in Turku, Finland is licensed and regulated by the Finnish Radiation and Nuclear Safety Authority – STUK.
Can Synexa work with "hot" samples?
Yes – a license is required to work when radioactivity of samples are above the free limits. Total radioactivity of samples at the site is closely monitored.
Which techniques does Synexa utilise for sample analysis of "hot" samples?
Our expert team harnesses various assays and platforms for PK sample analysis, immunogenicity & biomarker testing of radioactive samples in the GLP/ GCLP/GMP environment, including ECL (MSD), Gyrolab, ELISA, SPR (Biacore), TR-FIA (Delfia), AlphaScreen / AlphaLISA, cell based assays and radioimmunoassays (RIA).
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