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Jan 04,2022
Medicilon Bacterial Endotoxin Testing Solutions
Bacterial Endotoxin Test Procedure Bacterial endotoxin method development (sample volume 3 bottles/batch, one batch) Bacterial endotoxin method verification (sample volume 3 bottles/batch, three batches) Bacterial endotoxin test (sample volume 3 bottles/batch, three batches) Bacterial endotoxin is one of the components of the cell wall of Gram-negative bacteria: LPS Released after the bacteria die Bacterial endotoxinRead more
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Nov 26,2021
FDA Launches Online Center for Biocompatibility Testing
Recently, the FDA launched the Medical Device Biocompatibility Evaluation Resource Center, an online system designed to help users better understand and complete the biocompatibility evaluation of medical devices. This system is not intended to replace the international standard ISO 10993-1 “Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process,”, butRead more
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Nov 25,2021
Reagent Stability Testing of In Vitro Diagnosis
Stability research is an important content that runs through the entire IVD product development phase and supports the post-market research of IVD products. It is the basis for setting the product validity period. It can be used to judge the rationality of product production technology, formula selection, and packaging material selection. It is also AsRead more
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Nov 25,2021
The Failure of LC-MS Bioanalytical Research Method
A successful LC-MS bioanalysis method transfer can increase the confidence of the sender and recipient laboratories. However, because the transfer of LC-MS bioanalysis methods involves preliminary preparation, communication, and acceptance, and the content of each process is numerous, the negligence of individual details during the method transfer may cause the transfer to fail, and theRead more
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Nov 03,2021
Abnormal Result Caused by Hemolysis of Blood Samples
⑴ Influence on biochemical results: Specimen hemolysis is the most common interference and influencing factor in clinical biochemical tests. Hemolysis has an impact on a considerable part of biochemical testing items. Among them, total bilirubin (TBIL), aspartate aminotransferase (AST), total protein (TP), and albumin (ALB) are significantly increased after hemolysis; significant after hemolysis The itemsRead more
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Nov 03,2021
Common Biological Experiment Testing Items
Biological Test Items Under GLP Regulations: Single and multiple dose toxicity test (rodent)Single and multiple dose toxicity test (non-rodent) Reproductive toxicity test (I, II)Genetic toxicity test (Ames, micronucleus, chromosome aberration) Local toxicity test (allergic, irritation, hemolysis) Immunogenicity/Immune toxicology test Safety pharmacology test Toxicokinetic test Carry out systematic pharmacokinetic studies according to the requirements of theRead more
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Oct 12,2021
Understand Whether the Structure of the Synthetic API is Correct
The preparation and research of APIs is at a critical position in the chemical drug R&D process, and the structure of the prepared compounds is consistent to ensure that subsequent quality control studies, pharmacology and toxicology studies, and clinical studies are meaningful. Through the structure of the synthesized APIs Confirmation can characterize whether the structureRead more
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Sep 17,2021
Cytotoxicity-based Activity Test Method for Antibody Biotherapeutics
Antibody drugs refer to protein drugs containing antibody gene fragments. The specificity, safety and effectiveness of binding to target antigens have enabled them to achieve rapid development in some major clinical diseases. Before studying how antibody drugs affect the human body, it is necessary to investigate the effects of drugs on the interior of cells.Read more
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Aug 20,2021
What is pharmacokinetics?
In drug development, various parameters need to be established in preclinical trials before the drug is approved for preliminary testing in human subjects. Pharmacokinetics is an area of ​​research that helps scientists understand how molecules behave in the body. Overview of Pharmacokinetics Pharmacokinetics, sometimes referred to as PK (Pharmacokinetic), is a branch of pharmacology thatRead more
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Jul 31,2021
Bioanalytical Research Method
With the rapid development of the pharmaceutical industry, the research of biotechnology drugs has also entered a higher level of platform. Biotechnology drugs refer to therapeutic drugs produced through recombinant DNA technology or other innovative biotechnology-based biotechnology, which mainly include cytokines, plasminogen activators, recombinant plasma factors, growth factors, antibodies, vaccines and oligonucleotide drugs It isRead more
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Jul 31,2021
Biological analysis challenges of chemical drugs
New drug research and development is accompanied by high risks, high investment, and low returns. During this period, two important issues must be repeatedly verified: Is it safe and effective? Pharmaceutical R&D workers need to conduct systematic research on drugs through various preclinical and clinical trials to reveal or confirm the effects of test drugs,Read more
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Jul 22,2021
What is Accelerated Stability Testing?
The accelerated stability test places perishable products under stress to estimate the shelf life under normal conditions. In this test, the company encourages the product to fail in a short period of time in harsh environments, and use this to estimate what might happen under normal conditions. This eliminates the need to store the productRead more
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Apr 12,2021
What is Preclinical Testing of Vaccines​?
What is the Main Purpose of Preclinical Testing? Pre-clinical testing must be performed before clinical trials. The purpose of pre-clinical trials is to use human cell cultures or animals to evaluate the potential toxicity of a new therapeutic drug before the “in vivo” test is performed by human participants. The main goals of preclinical studiesRead more
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Apr 09,2021
What are Preclinical Trials?
Preclinical research refers to chemical synthesis or natural product purification research, drug analysis research, pharmacodynamics, pharmacokinetics and toxicology research, and pharmacy research conducted before the drug enters clinical research. Preclinical trials Content Preclinical research of drugs for drug registration, including drug synthesis technology, extraction methods, physical and chemical properties and purity, dosage form selection, prescriptionRead more
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Apr 02,2021
Details of success or failure in ELISA experiment operation
Enzyme-linked immunosorbent assay (ELISA) is widely used in the determination of various antigens and antibodies in clinical testing because of its high sensitivity and strong specificity. Although the ELISA operation is simple, there are also big articles in the small experiment. Each link of the ELISA operation has a great influence on the detection effectRead more
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Mar 25,2021
LC-MS/MS for Quantitative Analysis
After a century of development, LC-MS/MS has become more and more widely used in various fields such as medicine, food, environment, forensic medicine, and clinical medicine. Especially suitable for clinical testing, the scope of application far exceeds the scope of radioimmunoassay and chemical testing, which is unmatched by other methods. LC-MS/MS has the characteristics ofRead more
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Mar 24,2021
Comparative Analysis of LC-MS and LC-MS/MS
Liquid chromatography mass spectrometry (LC-MS) and liquid chromatography mass spectrometry (LC-MS-MS) are both precision testing instruments in the laboratory. The two are very similar, but there are also big differences. LC-MS can obtain total ion chromatograms by collecting mass spectra. Because electrospray is a soft ionization source, there are usually few or no fragments. ThereRead more
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Mar 12,2021
What is Preclinical in Vitro and in Vivo Research
Before testing candidate drugs in humans, their safety and efficacy (effectiveness) must be explored in preclinical studies. These studies can be “in vitro”, which means “in a container” in Latin, which refers to research using cell culture in vitro, or “in vivo”, which means “in vivo” in Latin. Refers to the research conducted inside theRead more
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Feb 26,2021
New drug toxicity testing service (European GLP/GCP standard)
The well-known European Institute of Toxicology and Experimental Medicine (Institut Toxikologie und Experimentelle Medizin, ITEM) is one of the most famous toxicology research institutions in Europe, and enjoys a world reputation especially in the research of respiratory toxicology. ITEM looks forward to cooperating with Chinese drug research and development institutions (pharmaceutical companies) in the safetyRead more
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Feb 18,2021
Analysis on the method of immunogenicity detection of biotechnology drugs
Immunogenicity refers to the nature of drugs that stimulate the body to form specific antibodies or sensitized lymphocytes. In the development of biotechnology drugs, immunogenicity testing is an important task. For patients, immunogenicity will affect the safety and effectiveness of drugs, and even cause life-threatening dangers to patients because of the crossover of anti-drug antibodiesRead more
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