Generic Drug Development Based on SPR Technology

The background of generic drug development

Generic drugs are the same as original drugs (or original drugs) in terms of dosage, safety and effectiveness, quality, effect, and indications. The goal of generic drug research is to achieve the "substitutability" of original research drugs in clinical applications. According to the US FDA,  the generic drug that can be approved must meet the following conditions. Firstly, it must contain the same active ingredients as the original research drug while the inactive ingredients can be different. Secondly, the generic drug must be consistent with the original drug's indications, dosage form, specifications, and route of administration. In addition, the quality standards of generic drugs need to meet the same GMP standard requirements as the original drugs. The development of generic drugs can provide more adequate clinical supplies and significantly reduce drug prices to ease the economic burden of patients. Generic drugs have important economic and social benefits such as reducing medical expenditures, improving the availability of medicines, and improving the level of medical services. Promoting the development of generic drugs is a boon for patients who suffer from rare diseases and other special diseases and who need more expensive original drugs. The most important part of the development process of a generic drug is that the evaluation of the active ingredient must be the same as that of the original drug. This is also the meaning of generic drugs.

Surface plasmon resonance (SPR) in the process of generic drug development

SPR technology can be applied to the development process of generic drugs and promote the entire development process with high efficiency. There are two most important steps in the development of generic drugs, as we can see in the figure below.

Fig.2 BIAchip™ in the process of generic drug development

Firstly, in the initial stage of the development of generic drugs, you need to determine the mechanism of action of the original drug in response to the corresponding diseases and the identification of the main active ingredients to lay the foundation for the subsequent development of generic drugs. The SPR technology platform can provide high-throughput affinity and kinetic testing to help you study the mechanism of action of the original drug. The active ingredients and the mechanism of action of the original drug are finally determined, which provides research ideas for the research of generic drugs.

Secondly, in the later stage of generic drug development, the most important step is to verify that the active ingredients and content of the generic drug are the same as the original drug, and the impurities must be non-toxic and harmless. This is the most important step in the listing of generic drugs-quality identification. The SPR technology platform can accurately determine the content of various ingredients in generic drugs, whether it is active ingredients or impurities, through high-throughput concentration analysis. The high-throughput analysis process of SPR technology can greatly promote your generic drug development process, and provide help for repeatability and parallel testing to reduce time-consuming. Based on the complex diversity of active ingredients to be tested and impurities, the flexibility of SPR technology allows Creative Proteomics to design and customize various types of chips for you to facilitate your generic drug development process.

Choosing the SPR technology platform of Creative Proteomics, you will greatly save time and money costs owing to high-throughput intermolecular interaction detection. All services are available on a 24/7/365 basis. If you have any questions or suggestions about our SPR services, please feel free to contact us right now.

For research use only. Not intended for any clinical use.