On November 16-18, 2020, Shimadzu made an appearance at the "Munich Shanghai Analytical Biochemistry Exhibition" with the theme of "Celebrating 50 Years of MS Innovation (1970-2020)".

Shimadzu is committed to promoting China's pharmaceutical industry/The development of the clinical industry actively supports various analytical and testing work in the fields of life sciences and biotechnology, new drug research, and generic drug evaluation, such as traditional Chinese medicine safety and evaluation, genetic toxicity impurities, packaging material compatibility, proteomics, genomics, and metabolomics.

In medicine/The clinical exhibition area will present to you the 2020 edition of the Chinese Pharmacopoeia, traditional Chinese medicine testing, vaccines, TDM, and biopharmaceutical solutions. In addition to the solutions, we will also present product introductions such as LC-40, LCMS-8045, GCMS-TQ8040NX, LCMS-8050CL, and Nexera UC Pre.

Solution Introduction

Part 01 2020 edition of the Chinese Pharmacopoeia

China is the hometown of natural medicines. With the development and research of traditional Chinese medicine resources, China has accumulated rich experience in the theory and clinical application of traditional Chinese medicine. For the treatment of many chronic diseases, the efficacy of traditional Chinese medicine is increasingly recognized by the Chinese people and well-known to the world. However, the barriers that prevent traditional Chinese medicine from breaking free not only include the difficulty in confirming the effective ingredients of traditional Chinese medicine, but also the excessive harmful residues in traditional Chinese medicine, such as pesticide residues and heavy metals, which have affected the reputation of traditional Chinese medicine in the world.

The 2020 edition of the Pharmacopoeia has added the "Fifth Method for the Determination of Multiple Residues of Prohibited Pesticides in Medicinal Materials and Herbal Pieces (Plants)" and revised the "0212 General Rules for the Inspection of Medicinal Materials and Herbal Pieces". *The inclusion of prohibited pesticide residue detection items, *, and detection methods into the four general rules has formed an overall inspection standard, which puts forward higher requirements for the safety control of traditional Chinese medicine.

target, aim at, address, focus on, in response toThe 2020 edition of the Chinese Pharmacopoeia will introduce the following solutions:

Chinese PharmacopoeiaInterpretation of the 2020 General Principles and Essays

Chinese Pharmacopoeia2020 version of the solution for banning pesticide residues and heavy metal detection in traditional Chinese medicine

Part 02 biopharmaceutical

Biopharmaceuticals have shown significant clinical advantages in the treatment of many life-threatening diseases, and major pharmaceutical companies at home and abroad have vigorously intervened in the research and development of biopharmaceuticals, and have achieved success in certain fields.

*Drug Evaluation Center（CDE released two guiding principles in October 2014 and December 2014, namely the draft guidelines for the development and evaluation of biosimilar drugs and the technical guidelines for stability research of biological products. In March 2015, CDE also released the trial guidelines for the development and evaluation of biosimilar drugs, aiming to provide more comprehensive guidance for the development and quality control of biological drugs. Referring to the guiding principles of important domestic and foreign institutions (such as NMPA, ICH, PIC/S), Shimadzu can provide a complete solution for the research and development, production, and quality control of biopharmaceuticals.

For biopharmaceuticals, the following solutions will be introduced:

Solution for Development and Clinical Trials of Shimadzu Protein Biopharmaceuticals

Part 03 Vaccine industry

Vaccines, as preventive drugs, provide the body with the ability to resist diseases before they occur, which is more significant than therapeutic drugs. Producing high-quality vaccines and strictly controlling the quality of vaccines is a major issue that concerns the survival and rise and fall of the nation. However, most of the existing problems with vaccines cannot be addressed by traditional physical and chemical testing methods such as liquid chromatography and ultraviolet spectrophotometry. The participation of modern and advanced physical and chemical technologies provides direction for solving existing vaccine problems.

Shimazu SelfSince 2017, we have collaborated with the China National Institute for Food and Drug Control and domestic vaccine companies. In addition to traditional physical and chemical detection methods such as liquid chromatography and ultraviolet spectrophotometry, we have also developed a comprehensive vaccine detection method from vaccine production to quality evaluation using technologies such as liquid chromatography-mass spectrometry, aggregate analysis, trace element analysis, electron probe, and MALDI-TOF. This method covers protein vaccines (such as pertussis), polysaccharide vaccines (such as 23 valent pneumococcal polysaccharide vaccines), viral vaccines (such as influenza vaccines), and polysaccharide conjugate vaccines (13 valent pneumococcal polysaccharide vaccines, meningitis vaccines, Hib vaccines).

For the vaccine industry, the following solutions will be introduced:

New Technical Scheme for Quality Evaluation of Shimadzu Vaccines

Product Information Introduction

In order to better and more intuitively understand the applications of various products, we will hold on-site technical exchange meetings and sincerely invite you to visit and exchange ideas.