GMP & GLP Solutions

CMC mainly refers to pharmaceutical research data such as production process, impurity research, quality research, and stability research, which is an important aspect of drug research and development.United Well Radiochemistry CMC laboratory has strict management. The procurement, approval, import/export ledger, financial bills, and experimental operation records of reagents and consumables required for radiopharmaceutical labeling and synthesis are in accordance with the CMC declaration requirements, to ensure the safety, effectiveness, and consistency of radiopharmaceuticals between batches, and to ensure that the manufacturing process, product characteristics, product testing and other methods are correctly defined.

Main functions

This is a complex and challenging process in which the radiochemical CMC laboratory provides comprehensive support for the radiopharmaceutical research and development process, and the chemical, biological, drug substance and preparation manufacturing in the laboratory. If you need a reliable partner to fully support your project, we can provide radiopharmaceutical analysis services for radiopharmaceutical registration, including method development and method validation, analytical testing and release, stability studies, mass separation, and compilation of CMC declaration documents.

Development of radioisotopes

With the rapid development of radioisotope tracing in the fields of biochemistry and molecular biology, the excellent performance of radioisotope-labeled molecular probes in revealing the physicochemical processes in vivo and in cells has opened up a new way for human to understand the basic phenomena of life. Given the foreseeable industry opportunities and unlimited future possibilities, United Well began to develop medical radiolabeled compound preparations that meet the requirements of radiochemical purity and radionuclide purity, stable composition, uniform physiological and pharmacological behavior, as well as the requirements of drug use in vivo, and are suitable for the diagnosis and treatment of human diseases. With reference to the Medium-to-Long Term Development Plan for Medical Isotopes (2021-2035) just released by the state, this work is of great significance not only to us, but also to the country.

Cyclotron productionTarget technology Separation and purification technologyDevelopment of nuclide generator

Development of target drugs

United Well has cooperated with many universities in China and has accumulated a wealth of valuable experience in the R&D of radiopharmaceuticals. The difference between radiopharmaceuticals and other drugs lies in that the radionuclides contained in the radiopharmaceuticals can emit radiation. With the use of appropriate detection means such as PET, SPECT and other detection equipment, we can make early and accurate diagnosis of some critical diseases such as cancer, tumor and inflammation, or evaluate and stage the treatment effect in the middle of the disease, and accurately treat the disease with radiation.

Preparation of radiopharmaceutical label ligands

The vast majority of radiopharmaceuticals are composed of two parts: radionuclides and radionuclide-labeled drugs, whose comprehensive reflection are the radiopharmaceuticals. The labeled drugs can be various forms of substances with certain physiological activity—new chemical entities (NCEs), such as polypeptides, proteins, hormones, blood components, antibodies, bioactive organic molecules, and so on. These new chemical entities have important specific biological targets for diseases, and these specificities bring new hope for United Well to develop new radiopharmaceuticals. After labeled with radionuclides, they can become radiopharmaceuticals with diagnostic or therapeutic effects.

Radiochemical quality control

United Well has established a set of strict radiopharmaceutical quality control system so far. This system is established to ensure a variety of effective and safe measures for radioactive labels in their application, which is characterized by the implementation of the overall process, the whole staff ‘s participation and flexible use of various scientific methods of comprehensive quality management. This is also the basis of radiopharmaceutical quality control. Our quality control of radiopharmaceuticals includes quality control of raw materials, quality control of design and trial production processes, quality control of production processes and auxiliary processes, product quality inspection, packaging quality control, storage and transportation quality control, and use process quality management, etc.

Activity meterRadioactive HPLC systemradioactive TLC, etc

Radiation protection

Because of the special properties of radionuclides, their properties can be utilized to carry out extensive and in-depth research in medicine. It is also because of their special nature that appropriate shielding of radioactive radiation is required during research to protect the life safety of researchers. Effective protection against various types of rays emitted by radionuclides is required.

Radioisotope development

United Well has carried out close cooperation with many universities and research institutions in China for many years. At present, we are making every effort to explore new nuclear reactions or preparation methods that can be used for the preparation of radioisotopes, develop new methods or technologies that can be used for the separation of radioisotopes, conduct research on the separation principles or mechanisms, and improve the varieties of radiopharmaceuticals.

Radiopharmaceutical development

The development of radiopharmaceuticals in China is slow, and the independent and original radiopharmaceuticals are scarce. The majority of radiopharmaceuticals used in clinical practice are foreign generic drugs. The research on radiopharmaceuticals mainly focuses on two parts: radionuclides and labeled bioactive substances. Screening suitable bioactive substances for labeling from the aspects of precision diagnosis and treatment is one of the focuses of our research and development of radiopharmaceuticals, including: peptides, proteins, hormones, blood components, antibodies, bioactive organic molecules, and so on. Screening suitable labeling ligands from these compounds has become the research focus of United Well researchers.

At present, United Well is conducting research on the technology and mechanism of the combination of radiopharmaceuticals, immunotherapy and chemotherapy, to improve the effect of the use of radiopharmaceuticals, to speed up the control technology of new intervention drug delivery technologies and preparations, to enhance the efficacy of radiopharmaceuticals and to perfect the varieties of radiopharmaceuticals.

Radiochemical quality control and CMC test analysis

As the qualitative, quantitative and standard process after the synthetic labeling of radiopharmaceuticals, the quality control of radioactive products mainly involves the quality control of raw materials, design and trial production, production and auxiliary processes, product quality inspection, packaging quality control, storage and transportation quality control, and use process quality management, etc. United Well has formed an effective and repeatable process flow, namely radiochemical quality control system.

At the same time, we can also provide all-round test analysis support for R&D AND production technology of radiopharmaceuticals:

Development, validation and verification of analysis methods Analysis method transferStandardization of reference substanceStability study of radiopharmaceuticalsStructure identification and purity characterization of impuritiesMethod development and verification of genotoxic impuritiesQuantitative analysis and CoA of toxic impuritiesTrace metal analysis and method developmentGMP release testing of drug substance or preparationProcess control strategy and QC support productioncGMP NMR chemical process support service and Q-NMR bulk drug quantitative analysisStudy on the solubility, dissolution, disintegration and permeability of agentsMicrobial limit test and CoA