Latest ArticlesThe research and development of monoclonal antibodies (mAbs) is a rapidly developing field. From the first generation of murine mAbs to the fourth generation of fully human mAbs, the efficacy and safety of mAbs in the treatment of various diseases have been continuously improved. In order to regulate the development and evaluation of mAbs, drug regulatory agencies and pharmacopeias of America and China have tried to issue feasible test procedures and acceptance criteria for quality evaluation of mAbs and biosimilars. Mass spectrometry (MS) technique with high sensitivity, resolution, selectivity, and specificity has become an important tool to evaluate the quality characteristics of monoclonal antibody-related products or specify mAb quality. The research of MS-based monoclonal antibody study involves structure characterization, impurity analysis, pharmacokinetics/pharmacodynamics (PK/PD), etc. This review focuses on the current quality control requirements of mAb related products and the development of MS technique for mAb quality characterization and specification. It is expected to provide information and references for evaluating the quality of monoclonal antibodies under research and development.
The major challenge in the development of recombinant biologics lies in generating and isolating rare high-producing stable single clone in a short period of time. The selection marker is an essential component of the plasmid vector, it plays an important part in the generation and screening of producing cell lines. Engineering the selection marker to enhance the stringency of selection for high producing cells is one of the most effective approaches to improve the cell line development process. Here, using Chinese hamaster overy (CHO) cells as an example, we introduce the application of selection marker for generation of recombinant biologics producing mammalian cell lines, methods of engineering the selection markers to enhance the selection stringency, and propose considerations on cell substrate stability and selection marker safety, in order to provide references for high-efficiency development of recombinant biologics.
Four cadinane-type sesquiterpenes were obtained from the petroleum ether of 95% ethanol extract of Eupatorium adenophorum Spreng by using an HP-20 macroporous resin column, silica gel, and semi-preparative HPLC. Their structures were determined by physical, chemical and spectroscopic methods and identified as eupatorinol (1), (+)-(5R, 7S, 9R, 10S)-2-oxocadinan-3, 6(11)-dien-12, 7-olide (2), (1S, 4R)-7-hydroxycalamenen-3-one(3) and (-)-(5R, 6R, 7S, 9R, 10S)-cadinan-3-ene-6, 7-diol (4). Among them, compound 1 is a new cadinane-type sesquiterpene, and compound 3 was isolated from this genus for the first time. In bioassay, none of these compounds displayed obvious cytotoxicity.
This paper showed bioprinted HepG2 tumor tissues used for studying the sonodynamic anticancer activity of chlorine e6 (Ce6). HepG2 cells were printed by using alginate/gelatin/hydroxyethyl cellulose composite biomaterial as bio ink and cell viability was detected with Live-Dead assay and MTT proliferation. The ultrasonic intensities of self-built micro ultrasonic device under different powers were estimated by using the temperature change caused by the conversion of acoustic energy to heat energy. Ce6 of 14.3 and 28.6 μg·mL-1 were acted on two-dimensional cultured and three-dimensional printed HepG2 cells, and the antitumor activity of Ce6 was detected by MTT method with ultrasound intensity of 0.15 W·cm2 for 60 s. The results showed that the activities of bioprinted HepG2 cells were as high as 95%, and tumor microspheres were formed after 7 days of culture. The ultrasound intensity was lower than 3 W·cm2, which belonged to low ultrasound intensity and had no damage to normal hepatocyte LO2 cells. By comparing the antitumor activity of Ce6 on 2D cultured and printed HepG2 cells, it was found that the anticancer activity of Ce6 on bioprinted HepG2 cells was 63.4% lower than that on 2D culture cells, indicating the acoustic drug resistance of three-dimensional tumor model. Bioprinted tumor tissues show the potential in the application of in vitro activity evaluation models for sonodynamic therapy.
Zika virus (ZIKV) is an emerging mosquito-borne virus that is associated with severe congenital brain malformations in the fetus and Guillain-Barré syndrome in adults. However, there are currently no drugs or preventive vaccines approved for ZIKV infection. Here, ciclesonide has been found significantly against ZIKV activity by plaque and cytotoxicity assays in vitro, and its 50% effective concentration (EC50) to ZIKV SZ01 and MR766 are (0.40±0.22) and (1.59±1.08) μmol·L-1, respectively. Its 50% cytotoxic concentration (CC50) to Vero cells are (64.70±7.33) μmol·L-1; Virus yield reduction and Western blot assays showed that ciclesonide can inhibit replication of ZIKV. In addition, ciclesonide can also inhibit the replication of ZIKV in A549 cells; the results of time of drug addition analysis indicated that ciclesonide mainly acts on the ZIKV RNA synthesis stage. Ciclesonide can also inhibit the internalization of ZIKV. These results indicated that ciclesonide is a potential drug against ZIKV.
The solubility/dissolution, hygroscopicity and mechanical properties of drug candidates have a profound effect on oral bioavailability, processability and stability. The physicochemical properties of crystalline drug are closely related to inner crystal structure. Crystal engineering technologies, as strategies of altering the crystal structure and tailoring physicochemical properties at molecular level, possess the potential of enhancing the pharmaceutical performance of product. The current article reviewed the modification of drug solubility/dissolution, hygroscopicity and mechanical properties by crystal engineering technologies through polymorphic selection, amorphization/co-amorphization, as well as co-crystallization, which provided a reference for the applications of pharmaceutical crystallography in improving physicochemical properties and druggability.
Salvia miltiorrhiza Bge. is one of the most important traditional Chinese medicinal plants and is used for a variety of diseases and disorders, including cardiovascular diseases, hepatocirrhosis, chronic renal failure, Alzheimer's disease, angina pectoris, myocardial ischemia, liver diseases, and diabetic nephropathy. In recent years, with the shortage of uncultivated resources and uneven product quality of cultivated germplasm, the biosynthesis and regulation of its main active ingredient has become a topic of interest. The use of a multi-omics approach with Salvia miltiorrhiza may provide genetic information as well as insights into the synthesis and regulation of the active ingredient at the molecular level. The paper presented a systematic review of the genomics, transcriptomics, proteomics and metabolomics associated with Salvia miltiorrhiza, summarized the advances in biosynthesis, regulation and related functional genes, and also put forward some scientific problems of Salvia miltiorrhiza that need to be further studied in the future.
Cannabis sativa, one of the ancient medicinal plants, has been used to alleviate pain and seizures. However, cannabinoids are often addictive, which limits their clinical use. Cannabidiol (CBD) as a non-psychoactive component of Cannabis sativa, has much weaker adverse effects than Δ9-tetrahydrocannabinol (THC) and therefore has received widespread attention. CBD has been found to ameliorate a variety of neuropsychiatric diseases, but the precise mechanism(s) of action are still unclear. Due to its low affinity for classical cannabinoid receptors current studies are focusing on other targets outside the endocannabinoid system. In the present review we mainly summarize the effects and molecular mechanisms of CBD in neuropsychiatric disorders, including epilepsy, neuropathic pain, anxiety, and depression.
3D printing technology has the advantages of accurate spatial distribution, accurate drug release and personalized drug dosage, which can make up for the shortcomings of traditional pharmaceutical technology. In recent years drop-on powder (DoP) 3D printing technology has been widely used in pharmaceutical preparation. Compared with other types of 3D printing technology, it is more simple, flexible and easy to operate. In 2015, Aprecia Pharmaceuticals announced that the US Food and Drug Administration (FDA) approves the launch of its first instant tablet Spritam® (levetiracetam) made with DoP 3D printing. After the first 3D printed medicine was launched, people also saw the unique advantages and broad prospects of DoP 3D printing technology platform in pharmaceutical preparation. This review focuses on the technical principles and key factors of DoP 3D printing, its application in the preparation field and its future development challenges.
We used the network pharmacology to explore the active ingredients and mechanism of action of Danqi tablets in the treatment of coronary heart disease, providing a theoretical basis for the treatment of clinical coronary heart disease. The TCMSP database was used to screen for active ingredients and targets in Danqi tablets; the predicted targets of coronary heart disease were screened through the GeneCards database; then, the intersection of the two targets was mapped; we used STRING database to construct a protein interaction network map and identified 65 cores targets; then, the DAVID database was used for enrichment analysis of gene ontology (GO) biological processes and KEGG signaling pathways, and finally the Cytoscape-3.6.2 software was used to construct a network diagram of traditional Chinese medicine-active ingredient-key targets-pathway. The H2O2-induced H9C2 cells injury model was used for experimental verification. The results suggest that Danqi tablets act on inflammatory factors and apoptosis-related pathways through quercetin, luteolin, tanshinone ⅡA, and other active ingredients, and improve proinflammatory or anti-inflammatory imbalances in the body and protect cardiomyocytes. This study confirms the multi-component and multi-target effects of Danqi tablets in the treatment of coronary heart disease, and provides an objective basis for their use in further experimental research and the clinical diagnosis and treatment of coronary heart disease.
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