Industrialization Progress of genetically modified pharmaceutical products

With the launch of Industrialization Progress of genetically modified pharmaceutical products in the EU and the US, the genetically modified pharmaceutical industry, as a new biopharmaceutical industry, has attracted more and more attention from Chinese pharmaceutical companies. Although there is an increase in related research in China, there are currently few genetically modified pharmaceutical products approved in the world, and the market is still in the cultivation stage. The research and application of genetically modified technology has a history of more than 30 years, but the emergence of genetically modified pharmaceutical products is a matter of recent years.

Definition

Genetically modified pharmaceutical products refer to drugs (such as insulin, interferon, interleukin, etc.) that use transgenic plants, animals and microorganisms obtained by transgenic technology as reactors to produce proteins needed by humans and animals. It is a single specific protein component, so genetically modified animals, plants and microorganisms are just a factory-like role, and the product is one of the required genetic components. The protein translated from exogenous genes. And it must also eliminate non-GMO ingredients as much as possible. Therefore, the main components of genetically modified pharmaceutical products are genetically modified proteins.

Genetically modified drugs already on the market

The transgenic goat milk developed by GTC Biotherapeutics of the US produces ATryn antithrombin, which was the first to be approved by the EMA in 2006. ATryn antithrombin is mainly used for the treatment of patients with surgical thromboembolism and is used for patients with congenital antithrombin deficiency. The FDA approved the product in the United States in 2009, and it is currently the only genetically modified drug sold in the EU and the US at the same time.

The recombinant human C1 inhibitor produced by transgenic rabbit milk developed by PharmingGroup NV in the Netherlands was approved by the European Food and Drug Administration in 2010. Indications for the treatment of genetic Angioedema have been applied for a new indication: delayed graft function ischemia reperfusion injury. This product is already available in the US.

Characteristics of Industrialization of Genetically Modified Drugs

On the whole, foreign genetically modified drug technology is relatively mature, policies and regulations are more complete, and regulatory measures are more standardized. The characteristics of its industrialization are as follows:

The host is dominated by animals that are easy to raise and produce more milk

Transgenic rabbits are becoming an increasing choice. It is easier to establish a closed and standardized feeding process for small animals that are easy to keep, such as rabbits. Most of the bioreactors are mammary gland reactors, because the drug is contained in the milk and will be excreted directly, causing less adverse reactions in transgenic animals, and the amount of rabbit milk can also meet commercial requirements. However, because plants are cheaper, research on genetically modified medicines using plants as hosts is increasing.

Proteins and active factors mostly concentrated in the blood

Genetically modified drugs are mostly common proteins or polypeptides. At present, it is not possible to perform glycosylation modification on protein drugs such as monoclonal antibodies. The main route of use of proteins or peptides is intravenous injection, so the transgenic drugs currently on the market and under development mostly focus on human blood proteases, plasma factors, peptides and vaccines. This is also determined by its clinical application characteristics.

Involve multiple regulatory authorities

Because genetically modified drugs involve both drugs and genetically modified animals and plants, the drug regulatory authorities must be integrated with specialized animal and plant regulatory authorities to provide services for the registration and review of genetically modified drugs, and to supervise the post-marketing genetically modified drugs . Currently in the United States, it is jointly reviewed by the FDA's Biological Drug Evaluation and Research Center and the Center for Veterinary Medicine. However, it is foreseeable that with the emergence of genetically modified drugs using genetically modified plants as hosts, corresponding regulatory regulations in the United States will also appear; similarly, Regulators will also adjust accordingly.

Conclusion

Genetically modified drugs have the advantages of low cost and high safety. The development of the genetically modified drug industry can not only reduce the cost of medicine in China and improve the quality of people's healthy life, but also regulate the industrial structure and promote the development of science and technology. Although China's research on genetically modified drugs started early, the industrialization of genetically modified drugs is lagging behind due to the lack of supervision in related fields in China and the lack of laws and policies.