Stability Study Services of Radioconjugates
Rdcthera is a leading radiopharmaceutical CRO specialising in the advancement of precision medicine through the provision of a comprehensive suite of services for the development and evaluation of radioconjugates, tailored to meet the specific requirements of each client. We have excellent analysis platform and standard procedures to provide cost-effective and customized complement radioconjugate stability study services for global clients.
Overview of Radioconjugate Stability Studies
Radioconjugates work by delivering a cancer-killing radioisotope combined with a targeting agent that seeks out cancer cells. Stability studies of radioconjugates are critical to their effectiveness and safety in clinical applications. Due to their complex nature, these compounds are susceptible to degradation over time, thus affecting their therapeutic potential. Stability studies allow researchers to gain insights into the chemical and physical changes that occur in radioconjugates under various conditions, thus optimising the chelates, the mode of administration.
Fig. 1. RP-HPLC radiochromatograms (System 3) of the stability studies. (Masłowska K, et al., 2022)
Our Services
Rdcthera provides stability analyses in different media, including in human serum and phosphate buffered saline. We are also able to provide activity concentration assays for defined periods of time as well as distribution assessments. With our comprehensive range of methods for the stability study of radioconjugates, enabling clients to choose the most appropriate method for their specific project needs.
- Real-time Stability Testing
- Long-term Stability Studies
- Accelerated Stability Testing
- Forced Degradation Studies
- In Vivo Stability Testing
- In Vitro Stability Testing
ICH Guidelines
Our team, proficient in the relevant ICH guidelines, ensures we deliver stability data driven by regulations, suitable for your biopharmaceuticals and regulatory submissions.
Custom Solutions
Each radioconjugate and each project's needs are unique, so we offer our clients a customised service to ensure that the conditions for stability studies are reasonable. Whether your needs include rapid stability testing, compatibility analysis with different excipients, or evaluation under simulated physiological conditions, our team can tailor a detailed solution to the specific situation.
Cutting-edge Equipment and Platforms
Rdcthera is equipped with industry-leading technologies to facilitate rigorous stability analyses. Our arsenal ranges from HPLC systems to advanced imaging technology, providing the essential tools for comprehensive and accurate assessments of radioconjugates.
Stability Test Programme Design
- Stability study time points
- Time limit for completion of testing after removal of stability samples
- The time limit for the sample to be taken out of the stability box and handed over to the inspection post
- Selection of stability test conditions
- Placement of the product in the stability test
If you are interested in our radioconjugate stability study services, please contact us now and our team of experts will be happy to answer any questions you may have and learn how Rdcthera can support your research and development needs.
Reference
- Masłowska K, Witkowska E, Tymecka D, et al. (2022). Synthesis, Physicochemical and Biological Study of Gallium-68- and Lutetium-177-Labeled VEGF-A165/NRP-1 Complex Inhibitors Based on Peptide A7R and Branched Peptidomimetic. Pharmaceutics. 14(1):100.
For research use only. Not intended for any clinical use.
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