Industry news_News_Qijian Bio-Pharmaceutical Co.,Ltd.

API (Butylphthalein) R&D Site, Production Site Verification and GMP Compliance Inspection of Jilin Qijian Bio-Pharmaceutical Co.,Ltd successfully passed.

26 2023/09

CPHI Worldwide will be held in Barcelona, Spain on October 24-26, 2023.Jilin Qijian Bio-Pharmaceutical Co.,Ltd will attend the exhibition, Booth No: 80Q19, welcome to visit us.

26 2023/09

Jilin Qijian Bio-Pharmaceutical Co., Ltd. participated in the 2023CPHI Southeast Asia Exhibition

CPHI South East Asia 2023 has been held at Queen Sirikit National Convention Center, Bangkok, Thailand from July 12-14, 2023.

17 2023/07

Jilin Qijian Bio-Pharmaceutical Co., Ltd. participated in the 2023CPHI Southeast Asia Exhibition

Qijian was invited to participate in "China Service Trade Fair 2021”

Our company was invited to participate in the "China Service Trade Fair 2021" which held in Beijing from September 4 to 7, 2021, Li Wei, Vice Governor of Jilin Province, visited Qijian 's booth, he encouraged us to strengthen exchanges and promote the development of service trade.

10 2021/09

Qijian was invited to participate in "China Service Trade Fair 2021”

Analysis of drug regulatory trends: more accurate, transparent and efficient!

After decades of hard work, a drug regulatory system that conforms to the development law of the drug industry and meets the public's needs for safe and effective drug use has basically been formed. The author believes that the future development of drug supervision will show a more accurate, transparent and efficient trend on the basis of the existing system. Increased proportion of technical supervision The continuous advancement of science and technology has made new technologies and new processes more widely used in the pharmaceutical industry, but this application has both legal and illegal applications. Therefore, the proportion of technical supervision in the process of drug supervision will continue to increase, and it will gradually transition from a supporting role to an important part of supervision, so as to adapt or promote the legal application of new technologies in the development of the pharmaceutical industry and combat illegal applications. ⒈ The drug standard system is continuously improved Since its establishment in 1953, the Pharmacopoeia has had ten editions. Since 1985, it has been revised every five years. Each revision will add new drugs and raise new standards. In the future, the 5-year revision system of the Pharmacopoeia will continue, and each revision will be carried out in accordance with the latest and strictest technical requirements, and more drugs will be included in the Pharmacopoeia. At the same time, a large number of the latest research results and supplementary testing methods formed by exploratory testing will continue to be supplemented and improved in the revision of the Pharmacopoeia and the revision of drug standards. In addition, the revision of other drug standards not included in the Pharmacopoeia has also been gradually normalized and institutionalized. The continuous improvement and enforcement of standards will continue to increase the safety and effectiveness of medicines, and will also provide more possibilities to combat and prevent technical fraud by exploiting standard loopholes and lag. The formulation and revision mechanism of drug standards will also change. More scientific research institutions, inspection institutions, colleges and universities and other technical organizations will participate in the formulation and revision of standards using more clinical practice and verified data. 2 The quality management system escorts the sea The management standard system composed of GMP, GSP, GLP, GCP, GAP, etc., was implemented in my country in the 1980s, which greatly promoted the development of the pharmaceutical industry and the improvement of the quality level. In the future, the quality management system will strictly revise the quality management practices and add appendices in accordance with international drug quality management standards and technical requirements, strictly implement certification and post-certification follow-up inspections, and adopt a combination of "dual random" and unannounced inspections to continuously increase the quality of the products. Great implementation efforts will truly realize the comprehensive and standardized management of drug quality from a technical point of view. 3 The monitoring effect of adverse drug reactions is effectively exerted In the future, the reporting channels for adverse drug reaction monitoring will be more extensive. In addition to the direct reporting points and sentinel institutions of professionals, the public platform for the society will be opened. The power of adverse reaction reporting will continue to expand, and the people involved in reporting are no longer limited to regulatory and medical technicians, and more pharmaceutical companies and drug consumers will participate. The review of adverse reaction reports has been continuously rigorous, and the screening rate of valid data has been greatly improved. The application of adverse reaction monitoring results continues to deepen, not only providing timely and accurate information for the control of harmful consequences such as market suspension and recall, but also feeding back monitoring data to production enterprises, research institutions and standards revision departments. 4. Drug sampling test has a stronger supporting effect As the most effective method for supervising the quality of post-marketing drugs, the intensity of drug sampling inspection will continue to increase, and the increased investment and planned volume of sampling inspection will be more suitable for the regulatory needs of marketed drugs. The subdivision support function of the random inspection function is more obvious, and the evaluation function of the national random inspection plan will emphasize the coverage sampling of the same batch of varieties in the whole region and all links. The supervisory function of the local inspection plan will place more emphasis on the pertinence of the inspection. Combined with law enforcement inspections,

28 2018/09

Analysis of drug regulatory trends: more accurate, transparent and efficient!

Bacteria's integrated protein assembly line revealed for the first time

Many processes that take place in cells are integral to life. As two of them, transcription and translation allow the genetic information stored in DNA to be decoded into the proteins that form the proteins of all organisms such as bacteria, plants and humans. Scientists have known for half a century that the two processes are coupled in bacteria, but until now, they didn't know how. Now, in a new study, researchers from the University of Wisconsin-Madison (UW-Madison) and the Max Planck Institute for Biophysical Chemistry in Germany have revealed that a so-called "expressome" the exact structure of the complex. The results of the study were published in the April 14, 2017 issue of Science, with the title "Architecture of a transcribing-translating expressome". The corresponding authors of the paper are Robert Landick, a professor in the UW-Madison Department of Biochemistry, and Patrick Cramer, director of the Max Planck Institute for Biophysical Chemistry. The researchers say the study using the model organism Escherichia coli could help to understand how the bacteria affect human health, including better understanding gene regulation and developing new antibiotics. Landick explained, "The existence of this complex in bacteria has been proposed based on evidence, but so far, no one has confirmed its existence. This study is the first to demonstrate the ability to harness these two already complex machines. (i.e. transcription complex, or transcription machinery; translation complex, or translation machinery) forms a larger supercellular machinery (i.e. expressosome)." The transcription process uses RNA polymerase to convert DNA into RNA. Following this process, another molecular machine called the ribosome translates this RNA (more specifically, signaling RNA, or mRNA) into a protein that the bacteria can use to function. Rachel Mooney, a researcher in UW-Madison's Department of Biochemistry, said that in bacterial expressosomes, RNA polymerase and ribosomes form a complex structure to carry out the two processes in a coupled fashion, and the newly resolved The expression body structure helps to understand how this happens. Transcription and translation also occur in animals and humans, but the two processes are not coupled as in bacteria. Instead, they occur in two physically distinct parts of the cell. If scientists can discover a way to disrupt this expressosome, they may be able to develop drugs that target bacteria but do not harm human cells, the researchers said. These findings also extend to the study of the microbiome (the population of microbes in and on the human body). Ongoing research demonstrates how important the microbiome is to human health, and understanding gene regulation in these microbial populations is a vital part of these efforts. Today, this expressosome structure is the basis for this understanding. "In human biology, we tend to think of what happens in human cells, but there are at least as many bacterial cells inside and on our bodies as there are human cells," Landick said. is not common, then we used it as a model organism to extend our research to other bacteria that are critical to human processes." Landick, Mooney (UW-Madison team) collaborated with Cramer and Rebecca Kohler (German team) on the study. Equipment provided by the German team assisted in deciphering the structure of the expressosome. This expression body contains RNA polymerase provided by the UW-Madison team. "Our study explains past observations that these two processes (transcription and translation) are coupled together in these bacterial cells," Cramer said. Researchers are also interested in the origin of this complex. Why these two processes are coupled in bacteria but not in organisms such as humans needs to be studied from an evolutionary perspective. Landick explained, "One of the arguments against it is to simply think that bacteria are far ahead of us in evolution. It's counterintuitive, but only technically, they have far more descendants than us. Bacteria The evolutionary pressures faced have led to this very integrated and very efficient approach to transcribing and translating DNA into protein."

28 2018/09

Bacteria's integrated protein assembly line revealed for the first time