As a precision-based and personalized emerging therapeutic approach, cell and gene therapy (CGT) has demonstrated significant therapeutic potential in addressing malignancies, rare genetic diseases, degenerative disorders, and other critical health challenges. However, the commercialization of CGT inChinafaces core bottlenecks, including high R&D and treatment costs, uncertainties regarding long-term efficacy, and lagging payment mechanisms. This article systematically reviews global CGT technological trends andChina's opportunities, while conducting an in-depth analysis of systemic challenges across key stages of CGT development inChina—ranging from product R&D and manufacturing to clinical research, market approval, and healthcare reimbursement. Building on this analysis, the study proposes integrated strategies to enhance clinical accessibility and sustainable industrial growth of CGT products under the premise of safety and quality control. Recommendations include strengthening tripartite healthcare coordination (integrating medical services, pharmaceuticals, and insurance), establishing a comprehensive regulatory framework, optimizing clinical research ecosystems, and innovating risk-sharing payment mechanisms. These measures aim to accelerate patient access to cutting-edge therapies and bolster the core competitiveness ofChina's biopharmaceutical industry.

There is disagreement over the evaluation of the emergency response plan and procedures for the laboratory biological incident and accidents. With the support of National Health Committee of PRC, the Committee of Laboratory Biosafety of China Medicinal Biotech Association organized an expert seminar to discuss issues related to the emergency response plan and disposal for biological incidents and accidents in the high-level biosafety laboratory. The experts conducted thorough discussions on issues such as the classification and grading of the biological incident and accident of classification, as well as the the elements of emergency plans. The feasibility of the technical specifications for incident and accidents emergency response was fully discussed, and an expert consensus was formed on specific technical measures and management models.

Objective  To establish a mouse colon 26 (C26) cachexia model and observe the time-course changes of blood parameters and inflammatory factors.

Methods  The C26 tumor fluid was inoculated subcutaneously into the right flank of BALB/c mice. When the tumor grew to a diameter of approximately10 mm, the mice were sacrificed to take out the tumor, and the tumor homogenate was diluted according to 1:60 after homogenization, and then the cell liquid was injected subcutaneously at 200 μL/mouse. After the tumor cells were transplanted into the mice, the body weight and tumor volume were examined. The animals were sacrificed on 12 d and 18 d after tumor inoculation, and then brown adipose tissue (BAT), epididymal white adipose tissue (WAT), quadriceps, gastrocnemius muscle, spleen, thymus and tumors were extracted for detection. After the tissue samples were obtained, the plasma samples were taken for cytokine detection. Blood cells were collected for differential analysis of blood types and CD4⁺/CD8⁺ lymphocytes. Pathological sections and HE staining were performed on adipose tissue.

Results  After the C26 tumor fluid was inoculated subcutaneously in BALB/c mice, the body weights of the mice in the tumor group were decreased significantly on 12 d and 18 d after tumor inoculation. The weights of BAT were decreased significantly at

12 d and 18 d, the lipid droplets in BAT became significantly smaller, and the cytoplasmic content of the lipid droplets were increased. The weights of the epididymis WAT were basically unchanged as compared with the control at 12 d after tumor inoculation, but the weights were significantly reduced after 18 d, and the lipid droplets of WAT were slightly smaller after 12 d of tumor inoculation, and significantly smaller at 18 d, and WAT was browned. The weights of the quadriceps and gastrocnemius muscles in the tumor group were also reduced as compared with the control group on 12 d or 18 d after tumor inoculation. The spleen volumes of the animals in the tumor group became larger, and the spleen weights were also increased significantly. Thymus weights were decreased at 12 d or 18 d after tumor inoculation. The results from flow cytometry showed that there was no statistically significant difference in the number of CD4⁺/CD8⁺ cells in the blood of mice for the control and tumor group. After 12 d of inoculation, the content of IL-6 inplasma was increased significantly, and after 18 d of inoculation, the concentration of IFN-γ was decreased significantly, and the contents of IL-1, TNF-α and IL-6 were increased significantly. After 12 d of tumor inoculation, the RBC, HGB, HCT%, MCH, PLT and PCT% in the tumor group were significantly lower than those in the control group, and the MON% was also significantly higher than that in the control group. After 18 days of tumor inoculation, RBC, HGB, HCT%, LYM% and BAS% were significantly decreased as compared with the control group, RDW%, WBC, LYM, MON, NEU, MON% and NEU% were significantly increased as compared with the control group.

Conclusion  We successfully construct a mouse model of C26 cachexia, which is characterized by weight loss, muscle and fat loss, browning of WAT, enlarged spleen, shrinking thymus, obvious changes in blood count, etc., and especially the changes of IL-6 inthe early stage are noteworthy. The establishment and validation of this model provides a reliable basis and reference for us to study cancer cachexia.

Objective  Streptomyces thermotolerans is a producer of Carbomycin, which is commonly utilized in the industry for biotransforming Tylosin into acetylisovaleryltylosin. However, the whole genome sequence information of this strain has not been reported. Herein, the whole genome of S. thermotolerans ATCC 11416 was sequenced and analyzed by bioinformatics software to predict the putative biosynthetic gene cluster (BGC) of secondary metabolites, as well as comparative genomics research.

Methods  The mycelium of S. thermotolerans ATCC 11416 was cropped, the qualified genomic DNA was extracted, and the whole genome of S. thermotolerans ATCC 11416 was sequenced using sequencing platform Illumina combined with PacBio. The resultant genomic sequence was analyzed by anti-SMASH software to find the BGC of secondary metabolites and the deduced compounds produced by these BGC, and the transcription level of these BGC was identified by qPCR. The whole genome of ATCC 11416 comparisons with other streptomyces were analyzed by TBtools software.

Results  The genome of S. thermotolerans ATCC 11416 consisted of a linear chromosome with a genome size of 8 279 432 bp and was presumed to contain 7356 genes with a GC content of 71.65%. It contained 66 tRNA and 18 rRNA sequences, and multiple repeats sequences had been identified. The BGCs of 26 secondary metabolites were identified from the genome, of which Cluster 8 was responsible for carbomycin biosynthesis. Using qPCR detection and comparison with key genes in Cluster 8, it was found that the functional genes in Clusters 1, 7, 13, 14, 15, 19 and 21 exhibited higher expression activity, while those in Clusters 5, 6, 9, 11, 12, 16, 18 and 24 showed lower expression activity. The functional genes in Clusters 2, 3, 4, 10, 17, 20, 22, 23 and 25 were almost not expressed, indicating putative silencing gene clusters. Among the silent gene clusters, Clusters 4, 10, 17, 20, 23, and 26 were low homologous with the known gene clusters and might be responsible for synthesizing new compounds. Genomic comparative analysis showed that S. thermotolerans ATCC 11416 and S. ambofaciens ATCC 23877 exhibited higher homology, and both produced 16-membered macrolide antibiotics. Genomic rearrangement phenomena such as multiple flips and translocations were found in genomic comparison.

Conclusion  The thermotolerant actinomycete Streptomyces thermotolerans ATCC 11416 harbors a medium-sized genome containing 26 BGCs, including a number of silent gene clusters with low homology. This lays the foundation for the subsequent activation of these silent gene clusters through molecular biological approaches to obtain new compounds.

Objective  To develop a self-formulated cryopreservation solution for human umbilical cord mesenchymal stem cells (hUC-MSCs) free of animal-derived components and with a low concentration of DMSO and assess its safety, stability, and other characteristics.

Methods  A preliminary experiment was conducted to formulate a cryopreservation solution free of animal-derived components and with a low concentration of DMSO. hUC-MSCs from three different donors were cryopreserved using a traditional controlled-rate freezing solution, or each of two non-controlled-rate freezing solutions (Stem-Cell Banker and the self-formulated cryopreservation solution), and then stored in a vapor-phase liquid nitrogen tank at temperatures below –150 ℃. The traditional cryopreservation solution was cooled using a controlled-rate freezing box and a controlled-rate freezing device. After 24 h, the cells were thawed and analyzed for safety (bacterial and fungal detection, mycoplasma and endotoxin testing, karyotype analysis, abnormal toxicity testing) and efficacy (differentiation potential, immunomodulatory function testing) as well as cellular characteristics (cell morphology, viability, cell surface marker testing) to assess the quality of cryopreservation.

Results  The cell viability, sterility testing, mycoplasma, and abnormal toxicity testing all met the standards without any abnormalities. Flow cytometry was used to detect the expression of cell surface markers CD73⁺, CD90⁺, and CD105⁺ and there was no significant change. The low expression of CD34^- and CD45^- showed no significant change. The differentiation potential into osteoblasts, adipocytes, and chondrocytes was not affected by the cooling method. G-banding technique confirmed that the karyotypes of all groups were normal human diploid. The cryopreservation solution exhibited inhibitory effects on Th1/2/17cell proliferation and promotional effects on Treg cell proliferation.

Conclusion  The self-formulated cryopreservation solution has the potential for clinical use, with advantages of a clear formulation, ease of batch preparation, minimal batch-to-batch variation, good safety profile, wide equipment applicability, and convenient and stable operation for personnel.

Plant exosome-like nanovesicles (PELNs) are an emerging nanotherapeutic agent and delivery platform with the potential for disease treatment. They can be utilized as carriers for drugs to target disease sites, playing a dual role in therapeutic delivery. Additionally, PELNs exhibit natural characteristics and low immunogenicity. This review systematically introduces the biological functions of PELNs, including their anti-inflammatory, anti-aging, anti-tumor, antioxidant stress, hepatoprotective, and anti-viral properties. The biological applications, such as endogenous and exogenous drug-carrying strategies using PELNs as delivery vectors, highlight the significant potential and advantages of utilizing PELNs for therapeutic purposes and drug delivery.

As important organs in the body, the liver and spleen not only carry out their respective physiological functions but also work together to maintain internal environment homeostasis through their interactions. This review comprehensively summarizes the liver-spleen axis, a critical physiological network that integrates metabolism, circulation, immunity and neurological functions. It explores the mechanisms of action and clinical application prospects of the liver-spleen axis in the pathogenesis and progression of various diseases. By summarizing the latest research advancements, this review discusses the functional connections of the liver-spleen axis in pathological states such as metabolic disorders, infectious diseases, autoimmune conditions, and cancers. The aim is to provide novel insights for the prevention and treatment of related diseases.

Objective  To study the tissue distribution characteristics and long-term survival of chimeric antigen receptor T (CAR-T) cells U87 targeting at human trophoblast cell surface antigen 2 (Trop2) in tumor-bearing immune-deficient mice.

Methods  A xenograft tumor model was established by subcutaneously inoculating NCG mice with Trop2 high-expressing BxPC-3 cells. Each mouse was then administered a single dose of U87 cells (5 × 10⁶ cells/mouse), followed by continuous observation until 84 days post-administration. Clinical symptoms and body weight changes were observed. Peripheral blood samples were collected at 3 hours, day 4, 7, 10 and 14, and week 3, 4, 6, 8, 10 and 12 after the administration of U87 to determine the phenotype of hCD3⁺ and hCAR⁺T cells via flow cytometry. Various tissues of the animals were harvested and the copy number of the distribution of the subjects in different tissues was determined by quantitative PCR at week 1, 2, 3, 4, 6, 8 and 12 after the administration of U87 cells. Concurrently with tissue collection for distribution analysis, the tumor injection site and surrounding tissues of female animals were collected to detect hCD3⁺ expression, aiming to evaluate the tumor infiltration capacity of U87 cells.

Results  During the study period, hCD3⁺ and hCAR⁺T cells were consistently detectable in the peripheral blood of the animals. This result was generally consistent with tumor elimination, suggesting that the two weeks following cell administration was the peak period of in vivo tumor expansion and U87 killing effect. After immunohistochemical staining of tumor tissues, human lymphocytes were identified in the tumors of the U87 group, but none of these cells were seen in the tumors of the control animals. The immunohistochemical findings were basically consistent with the results of the CAR-Trop2 gene content assay in tumors by PCR method and the trend changes in the content of peripheral blood hCD3⁺ and hCAR⁺T cells by flow cytometry, suggesting that U87 can specifically target the tumor site and exert anti-tumor effects.

Conclusion  This study validates the targeting effect of CAR-T cells on solid tumors from different dimensions in a xenograft mouse model, providing a valuable reference for the preclinical safety evaluation of related products.

Objective  To confirm the sensitizing effect of D-methionine (D-Met) on meropenem (MEM) against vancomycin-resistant Enterococcus (VRE), and to preliminarily explore its sensitizing mechanism.

Methods  The in vitro sensitization activity of D-Met on MEM against VRE was detected using broth microdilution method, checkerboard assay and bactericidal curve measurement. The in vivo sensitization activity was assessed utilizing various models, including Galleria mellonella larvae infection, mouse thigh infection, and mouse thigh pocket infection, using indicators such as survival rate or tissue homogenate bacterial count. The preliminary sensitization mechanism was explored through a Van-FL D-Ala-D-Ala dipeptide tail binding assay and the determination of the DltA enzyme-catalyzed reaction rate.

Results  The results from the in vitro antibacterial activity assay and checkerboard assay indicated that D-Met enhances the anti-VRE activity of MEM, with fractional inhibitory concentration index (FICI) values below 0.5, suggesting synergistic anti-VRE effects. Specifically, the combination of 1 μg/mL MEM and 20 mmol/L D-Met exhibited a bactericidal effect against VRE at 2 h and sustained this effect for up to 24 h. In the Galleria mellonella larvae infection model, the combination of MEM and D-Met improved anti-VRE activity; however, the mouse thigh infection and thigh pocket infection models did not reveal significant synergistic effects of D-Met and MEM. Preliminary investigations into the mechanism suggest that D-Met acts weakly as a substrate for the dltABCD pathway involved in the synthesis of wall teichoic acid, and D-Met does not play a role in substituting peptidoglycan D-Ala-D-Ala dipeptide tail of E. faecalis.

Conclusion  D-Met significantly enhances the anti-VRE activity of MEM in vitro, and this sensitization effect has been validated in Galleria mellonella larvae infection model. However, D-Met exhibits weak effects in the synthesis of wall teichoic acid and in substituting the D-Ala-D-Ala dipeptide tail, indicating that further exploration of the sensitization mechanism of D-Met is warranted.

In recent years, artificial intelligence (AI) technologies such as DeepSeek have made significant progress in biomedicine, particularly in the realm of cell and gene therapy (CGT). AI not only accelerates target discovery, gene editing, and the design of cell therapy products, but also has the potential to optimize manufacturing processes, enhance quality control, facilitate personalized treatments, and aid in the design of clinical trials. This article reviews the applications of AI technologies including machine learning, deep learning, and data analysis in CGT. It explores their potential to drive innovation, improve treatment efficiency, reduce costs, and expedite the translation of laboratory findings to clinical practice. Additionally, the article provides an overview of current challenges and outlines future development directions in this dynamic field.

Objective  To evaluate the feasibility of replacing imported materials used in the downstream with domestic equivalents.

Methods  Taking the purification of a monoclonal antibody as an example, the feasibility of replacing imported materials with domestic materials in the downstream purification process was evaluated by comparing indicators such as binding capacity, impurity removal efficiency, and product recovery rate. The materials involved included the depth filters, virus removal filters and ultrafiltration membranes used in the filtration steps, as well as the affinity chromatography resins, anion exchange and cation exchange chromatography resins used in the chromatography steps.

Results  The domestic Cobetter filter membranes exhibited good process performance, with some properties even exceeding those of imported materials. However, the permeation efficiency of the ultrafiltration membranes is required further optimization. The domestic resins materials showed comparable process performance to their imported counterparts, demonstrating characteristics such as high loading capacity and good process robustness in the process.

Conclusion  The performance of domestic materials is comparable or even superior to that of the corresponding imported materials. it is feasible to replace imported materials with domestic ones. This study provides preliminary data for the adoption of domestic materials in the purification process of antibody drugs.

生物样本库是采集、管理和贮存生物样本组织和细胞样本并且结合医学结果、疾病信息、处理情况、环境信息的综合资源库，可以协助科研工作者研究疾病的病理生理学机制、明确诊断和指导最终治疗。本文探讨目前国内外生物样本库的发展情况、质量控制、信息管理以及资源共享等问题，以推进生物样本库平台化、标准化建设。

生物医学中心实验室是指从事医学、生物和科学技术研究的，符合国家生物安全防护水平为一级或二级的科学实验场所，是 24 小时开放的科研公共平台。

2023 年 6 月《生物医学中心实验室建设与管理要求》由中国医药生物技术协会组织专家审定后批准立项。中国医药生物技术协会科研实验室建设与管理分会成立标准编制起草小组，正式启动团体标准编制工作。

科研水平是评价生物医学单位综合实力的重要指标，因此各单位普遍加大了科研实验室硬件建设的投入力度，但以往国内生物医学单位的中心实验室在建设、运行和管理上仍沿袭过去传统体制下的模式，与当前快速上升的医学科研发展水平不相适应，不能有效满足现代医学科研的发展需求。国家尚缺乏对中心实验室安全运行、服务效率的监管依据等。因此有必要制订相关规范，指导国内生物医学中心实验室的建设与管理。

标准编制组首先对国内外相关行业规范、文献等进行了检索、分析、翻译和研究，对生物医学中心实验室建设与管理中涉及的一些重点问题进行了多次研讨。同时，开展了国内高校和医疗机构中心实验室建设与运行情况调研，对中心实验室建设与管理的现状和问题进行了分析。在此基础上明确了《生物医学中心实验室建设与管理要求》需要规定的关键内容，确定了《生物医学中心实验室建设与管理要求》框架原则。标准编制过程中共收到 265 条修改建议和反馈。编制组进行了多次汇总和梳理，采纳意见 251 条，部分采纳 2 条，不采纳意见 12 条。编制组对征集的意见进行了深入讨论和分析，对《生物医学中心实验室建设与管理要求》进一步完善；经过协会标准工作委员会审定、公示等程序，《生物医学中心实验室建设与管理要求》于 2024 年 6 月 14 日发布并实施。

《生物医学中心实验室建设与管理要求》是现行有效的法律法规和技术标准与生物医学中心实验室建设与管理具体实践的结合，将有效指导全国生物医学单位中心实验室的建设与运行管理，完善人员队伍建设体系，同时为科研中心实验室的评价和分级分类奠定基础。需要说明的是，本标准适用于新建或改扩建生物医学中心实验室（生物安全防护水平为一级或二级）的建设与管理，其他生命科学实验室可参照使用；不适用于非开放共享的科研实验室，例如第三方检测实验室、临床检测实验室以及其他出具正式检测报告的实验室等。

来自国内多所知名高校和医院中心实验室的二十余名专家学者，以及中国医药生物技术协会科研实验室建设与管理分会的数十家会员单位参加了本标准的编制工作，在此一并致谢。

Objective  To explore the relationship between pkinase-domain-containing protein (PuPK) and carbohydrate esterase family 4 protein (PuCE4) genes related to cell wall remodeling and the formation of sclerotia in Polyporus umbellatus under different concentrations of oxalic acid.

Methods  The full-length cDNA sequences of the genes encoding the cell wall remodeling proteins containing PuPK and PuCE4 associated with sclerotia formation in the medicinalungus P. umbellatus were cloned. The physicochemical properties, domain characteristics, and sequence alignment analyses of the proteins were predicted. Furthermore, the expression differences of these two genes in the hyphae and sclerotia of P. umbellatus under different concentrations of oxalic acid treatment were analyzed using quantitative real-time PCR (qPCR) technology.

Results  The full-length cDNAs of the PuPK and PuCE4 genes were found to be 1735 bp and 1900 bp, respectively, with open reading frames (ORFs) of 1200 bp and 1395 bp, encoding 399 and 464 amino acids, and the estimated molecular weights of 45.44 kD and 49.06 kD. Phylogenetic analysis indicated that PuCE4 shared a close evolutionary relationship with Trametes sp., while PuPK was most conserved with the fungus Dichomitus squalens. Compared to the control group hyphae, both PuPK and PuCE4 were significantly highly expressed in the sclerotia and mycelium of the low oxalic acid concentration group, while they were expressed at lower levels in the high concentration hyphae. In the same treatment group (low oxalic acid group and control group), the expression of these two genes in the sclerotia was significantly higher than that in the hyphae.

Conclusion  PuPK and PuCE4 are closely associated with cell wall reconstruction during P. umbellatus sclerotial formation. This study provides a scientific basis for further research into the effects of oxalic acid on the development of sclerotia in P. umbellatus and its relationship with cell wall reconstruction.

Ovarian cancer is considered the most deadly disease within the female reproductive system due to its subtle onset and challenges in early detection, often leading to diagnosis at an advanced stage. The primary treatment for ovarian cancer involves cytoreductive surgery combined with chemotherapy, with the most common combination being platinum drugs and paclitaxel. However, chemotherapeutic drugs are known for their high toxicity, potential for relapse, and susceptibility to resistance, prompting a current focus on researching new drugs to complement or potentially replace chemotherapy. Numerous studies have shown the ability of herbal extracts to inhibit the proliferation, invasion and metastasis of ovarian cancer cells. When combined with chemotherapy, herbal extracts have shown to enhance the effectiveness of treatment, minimize chemotherapy-related side effects, and reduce the risk of drug resistance. This review categorizes herbal extracts into herbal monomers, single-flavour herbal extracts, and compound herbal extracts based on their mechanisms of action, aiming to serve as a resource for integrating traditional Chinese medicine with Western medicine in the management of ovarian cancer.

In the new era of booming development in the life sciences, organoids have emerged as a key technology in the field of precision medicine, driving scientific research progress and medical breakthroughs. Patient-derived organoids have the ability to faithfully reproduce and maintain the omics characteristics and biological behaviors of the original samples, showcasing both inter-patient and intra-patient heterogeneity among tumor patients. Establishing organoid living biobanks is essential for conducting comprehensive tumor molecular and biological studies, offering valuable model resources for precision medicine. This review focuses on the current development status and application progress of tumor organoid living biobanks, providing a useful reference for precision medicine research based on organoids.

Objective  To explore the effects of ginkgetin on hepatic stellate cells (HSCs) in vitro and the underlyng mechanisms.

Methods  Immortalized human LX-2 cells and primary mouse HSCs were utilized in this study. The effects of ginkgetin on HSC viability, apoptosis, and fibrotic activity were evaluated by CCK-8 assays, flow cytometry, and Western blot. Furthermore, bulk RNA sequencing (RNA-Seq) and small interfering RNA (siRNA) were used to investigate the mechanisms involved.

Results  Ginkgetin (2.5 - 10 μmol/L) significantly reduced cell viability, induced apoptosis, and decreased the expression of fibrotic proteins (COL1A1 and αSMA) in a dose-dependent manner in both LX-2 cells and primary mouse HSCs. RNA-Seq analysis of LX-2 cells treated with ginkgetin (0 vs 5 μmol/L) revealed a correlation between ginkgetin and interferon γ (IFN-γ) signaling, with IFN-γ signaling being upregulated by ginkgetin. Western blot analysis confirmed the RNA-Seq results, showing increased STAT1 phosphorylation and protein expression of downstream interferon regulatory factors (IRFs, such as IRF1 and IRF8). However, the proapoptotic and antifibrotic effects of ginkgetin were abolished following STAT1 inhibition by siRNA.

Conclusion  Ginkgetin demonstrates antifibrotic properties on HSCs in vitro, with the mechanism involving the activation of STAT1 and induction of HSC apoptosis.

Objective  The aim of this study was to establish a simple and rapid method for the quantitative detection of the respiratory syncytial virus (RSV) prefusion F protein (preF) using enzyme-linked immunosorbent assay (ELISA).

Methods  Seven monoclonal antibodies (D25, palivizumab,101F, MED18897, AM22, AM14, motavizumab) targeting different epitopes of the RSV F protein, along with preF and postfusion F protein (postF), were expressed in HEK293 cells. By evaluating the binding capacity differences of the seven monoclonal antibodies to preF and postF, an antibody capable of recognizing both preF and postF was chosen as the coating antibody, while a specific preF-recognizing antibody was selected as the enzyme-labeled antibody. The optimal combination (motavizumab-D25) with the highest signal-to-noise ratio was employeded to establish a sandwich ELISA for the detection and quantification of preF.

Results  The sandwich ELISA method using motavizumab as the coating antibody and D25 as the enzyme-labeled antibody exhibited specific recognition and quantification of the RSV preF protein. The method demonstrated excellent specificity and sensitivity, with a detection sensitivity of 7.8 ng/mL, a linear range from 7.8 ng/mL - 0.5 µg/mL, and a correlation coefficient (r²) of 0.9932. The coefficient of variation for three repeated tests of the same sample ranged from 0.15% - 6.86%.

Conclusion  The sandwich ELISA method using motavizumab as the coating antibody and D25 as the enzyme-labeled antibody proved to be highly specific, sensitive, and stable. It can be effectively utilized for determining the preF antigen content in RSV vaccine products and early-stage research samples, thus laying a foundation for the development and optimization of RSV vaccines.

Objective  Explore the effectiveness of the combination of human umbilical cord mesenchymal stem cells (hUC-MSCs) and sodium hyaluronate (HA) in treating knee osteoarthritis (KOA) and study the in vivo biological distribution of hUC-MSCs in SD rats.

Methods  Mesenchymal stem cells were isolated by using human umbilical cord tissue as the starting material, and were expanded and characterized before the injection; The knee osteoarthritis model was established by left anterior cruciate ligament transection and meniscectomy on SD rats. HA solvent solution alone and hUC-MSCs suspension together with HA were injected into the joint cavity at 6 and 9 weeks after the surgery, respectively. All SD rats were euthanized at 13 weeks after the surgery, and the femoral bones of the knee joint were isolated for gross morphological observation, histological analysis and immunohistochemical staining. To study the biological distribution of hUC-MSCs, the knee osteoarthritis model was established by the same method as described above. 4 weeks after the surgery, DiR solution and DiR-labeled hUC-MSCs were injected into the joint cavity. DiR-labeled hUC-MSCs were also injected into the joint cavity of untreated SD rats as the control group. All the animals were subjected to in vivo fluorescence imaging at 10 minutes, 4 hours, 24 hours, 3 days, 7 days, 14 days, 21 days, 28 days, 35 days, 42 days, 49 days, and 56 days after the injection. Each group animals were euthanized at 3, 21, and 56 days post-injection, allowing for collection of the heart, liver, spleen, lung, kidney, whole blood, brain, testis, and knee joints (including synovium, cartilage, ligament, and muscle) to detect the human-specific gene SRGAP2.

Results  According to the gross morphological observation andscore, the combination of high-dose hUC-MSCs and HA exhibits better performance in repairing the appearance and structural damage of the knee joint in KOA. Based on the Modified Mankin scoring, both the treatment of HA alone and combinations of low, medium and high-dose of hUC-MSCs and HA could alleviate cartilage degeneration in KOA rats; The immunohistochemical staining of the joint tissues shown that the treatment of HA alone and combinations of low, medium, and high-dose hUC-MSCs and HA all inhibit the expression of matrix metalloproteinase 13 (MMP13) and the degradation of collagen II. According to the in vivo fluorescence imaging, after injected into the joint cavity of each group, DiR-labeled hUC-MSCs demonstrated more intensive fluorescence than DiR solution, and the fluorescence in the site of injection of all animals reached a comparable level at day 28 and became unobservable after day 56. In the DiR-labeled hUC-MSCs group, the hUC-MSC genome was detected in the animal's joint cavity (synovium, cartilage, ligament) on day 3, but not on day 21 and day 56. No transplanted cells were found in the heart, liver, spleen, lung, kidney, whole blood, brain, or testis at any of the time points.

Conclusion  In summary, this study demonstrates that the combined application of hUC-MSCs and HA is beneficial in the treatment of knee osteoarthritis. After intra-articular injection, hUC-MSCs showed no ectopic distribution, indicating the absence of systemic risk. These results are of great reference value to clinical practice.

Objective  The antitumor activity of the anti-body conjugate hIMB1636-MMAE against FaDu human pharyngeal carcinoma cells was investigated.

Methods  The affinity, proliferation - inhibitory effect, impacts on the cell cycle and apoptosis of hIMB1636-MMAE on FaDu human pharyngeal carcinoma cells were detected using methods including the CCK-8 assay and flow cytometry. The endocytosis activity of hIMB1636-MMAE was detected by laser confocal microscopy. Additionally, the in vivo antitumor activity of hIMB1636-MMAE was assessed by a FaDu cell-derived xenograft tumor in nude mice.

Results  hIMB1636-MMAE exhibited specific binding to FaDu human pharyngeal carcinoma cells, followed by endocytosis and subsequent transportation to lysosomes. It inhibited the growth of FaDu cells with an IC₅₀ value of 10.75 nmol/L. Furthermore, hIMB1636-MMAE effectively induced cell cycle arrest and apoptosis in FaDu cells, and completely suppressed the growth of FaDu-derived xenografts in nude mice.

Conclusion  hIMB1636-MMAE exhibits strong antitumor activity against FaDu human pharyngeal squamous cell carcinoma both in vitro and in vivo, supporting its potential as a promising therapeutic candidate for thetreatment of Trop2-positive human pharyngeal squamous cell carcinoma.

目的  建立高效液相色谱法检测 L-谷氨酰胺有关物质的方法并进行验证。

方法  采用高效液相色谱法检测 L-谷氨酰胺有关物质，从系统适用性、专属性、重复性和准确度、定量限、耐用性来验证方法的可靠性。

结果  该方法检测 L-谷氨酰胺有关物质系统适用性强，相对标准偏差 < 3%，同时拖尾因子 < 1.5，理论塔板数 > 15 000，分离度均 > 3；重复性高 RSD < 5%；准确度回收率在 80% ~ 120% 之间；专属性好，溶剂峰对检测物质不产生干扰；定量限低，可达到 12.5 μg/mL；耐用性好，改变流速和样品存放超过 48 h 对检测结果无影响。

结论  成功建立了高效液相色谱法对 L-谷氨酰胺有关物质的检测方法。

Transdermal absorption study, as a key part of the safety assessment of nanomaterials, primarily hinges on the selection of a suitable experimental model to simulate the transdermal behavior of the test material in the actual human skin. In the review, the common in vivo models, in vitro skin models, artificial 3D skin models, artificial membrane models, and skin injury models in transdermal absorption studies are summarized in terms of their basic structures, experimental principles, latest research progress, and practical applications in transdermal absorption studies of nanomaterials, and the advantages and disadvantages of the various experimental models in practical applications are analyzed, so as to lay the foundation for the establishment of a unified technical standard in the industry.

Objective  The objective of this study was to analyze and identify the components of the volatile oil of Hyssopus officinalis to distinguish between the genuine and counterfeit herbs, investigate the different compounds and explain the mechanism of its anti-dermatitis effect.

Methods  Gas chromatography-mass spectrometry (GC-MS) was utilized to identify the volatile oil components of 15 batches of genuine and counterfeit Hyssopus officinalis. Various analytical methods, including PCA, OPLS-DA, Bar-Plot, and ROC analysis, were employed differentiate between genuine and counterfeit medicinal materials and identify potential chemical markers for authentic Hyssopus officinalis. Network pharmacology tools such as SEA, Swiss Target Prediction, and Batman-TCM were used to explore the possible targets of key differential compounds.

Results  A total of 27 effective components in the volatile oil of Hyssopus officinalis were identified, successfully distinguishing between genuine and counterfeit medicinal materials. Potential chemical markers for identifying genuine Hyssopus officinalis were selected, including eucalyptol, D-menthol, 4-tert-butylphenol, and farnesol.

Conclusions  Eucalyptol, D-menthol, 4-tert-butylphenol, and farnesol may impact the antibacterial properties and distinctive fragrance of the medicinal materials. Additionally, 2-butyl-1-octanol in the volatile oil of Hyssopus officinalis may exert anti-dermatitis effects by inhibiting related inflammatory pathways.

科研实验室是开展科学研究的重要基地，其高水平建设与发展对推动科技创新、促进学科交叉和融合具有重要作用。以往医疗单位的科研实验室管理一直被忽视，包括国内大型的医学科研单位，其实验室建设和管理都不尽人意，由于各种原因导致的实验室安全事故也时有所闻。本文就科研公共实验室的规范化建设与管理作一概述，探讨如何更好地发挥其在科技创新中的重要作用，以期为国内各科研实验室在建设、发展及提升使用效率等方面提供参考。

There are several common challenges associated with the selection, application and disinfection of personal protective equipment and supplies for personnel entering high-level biosafety laboratories. With the support of National Health Commission of the People's Republic of China, the Committee of Laboratory Biosafety of China Medicinal Biotech Association organized an expert seminar to address specifications for the selection, use, and disinfection of positive pressure protective hoods in high-level biosafety laboratories. This paper thoroughly discusses the criteria and specifications for selection, proper wearing and removal procedures, routine maintenance and inspection protocols, as well as disinfection and verification standards for positive pressure protective hoods. An expert consensus was reached on specific technical measures and management practices to enhance safety in laboratory environments.

The ethnic medicines in Xinjiang, including Uygur, Kazak, and Kirgiz medicine, are harmonious but different and unified in diversity. These traditional medical systems reinforce each other, playing a vital role in disease prevention, treatment, and enhancing the reproduction and survival of ethnic groups. Xinjiang's unique geographical environment exhibits abundant medicinal resources, particularly in the field of treating infectious diseases. Numerous traditional prescriptions from Xinjiang's ethnic medicines have been developed as approved pharmaceuticals, widely used in clinical diseases such as respiratory diseases, urinary tract infections and oral infections. In addition, some of these products generate annual sales exceeding 100 million, highlighting their potential market value. In this review, we summarize the origins, ingredients, antibacterial, mechanisms, and clinical applications of Xinjiang ethnic medicines and products, aiming to promote the development of Xinjiang ethnic medicines.

Objective  The objective of this study was to optimize the process of protein removal in the production of Capsular polysaccharide type23Fin pneumococcus.

Methods  On the basis of single-factor experiments, we investigated the performance of protein removal with respect to three factors: pH, incubation time of bacterial solution, the concentration of CTAB. Additionally, the effects of various factors and their interactions on protein removal performance were examined using Box-Behnken design. The optimum process conditions were determined, and three batches of pneumococcal type23Fpolysaccharide were used to validate the optimized parameters.

Results  Response surface analysis revealed the following hierarchy in the influence of various factors on protein removal during the production of pneumococcal polysaccharide: incubation time of bacterial solution > pH > CTAB concentration. The optimal conditions for protein removal were identified as: pH = 6.0, incubation time = 24 h, and CTAB concentration = 4%. Under these conditions, the measured protein removal rate can reach 94.8%, indicating a 34.4% increase compared to the rates before optimization. Furthermore, the three batches of pneumococcal polysaccharide type23Fmet the quality standards outlined in the Pharmacopoeia of the People's Republic ofChina(2025 Edition).

Conclusion  By optimizing the protein removal process of pneumococcal polysaccharide, the quality and efficiency of pneumococcal polysaccharide were significantly enhanced, and the protein content was effectively controlled. This work provides a valuable reference for the purification of bacterial capsular polysaccharide.

目的  介绍应用于 SDS-PAGE 法测定蛋白质分子量的三种生物软件使用方法，并评价各软件计算蛋白质分子量的准确性及操作的便捷性。

方法  将两种蛋白分子量标准经 SDS-PAGE 电泳后，使用 Quantity One、Gel Pro Analyzer、Tanon Image 三软件以其中一个蛋白分子量标准为基准，计算另一样品中各蛋白条带的分子量，并与其理论分子量进行对比，从而评价软件计算结果的准确性。

结果  三种软件在 14 ~ 66 kD 范围内均能准确测定蛋白质分子量，误差不超过 1 kD。在 95 ~ 150 kD 范围内，116 kD 条带处 Quantity One 的测定结果更为准确（115.75 kD），而 Tanon Image 和 Gel Pro Analyzer的误差稍大（均为 118.78 kD）。

结论  三种软件均能较准确地用于蛋白质分子量的测定，可以替代传统的手工测量-计算法。国产软件 Tanon Image 尽管在高分子量（95 ~ 150 kD）范围内误差稍大，但其整体表现与国外软件相当，并且在操作简便性上更有优势，因而完全可以替代国外软件用于蛋白质分子量的测定，为我国研究者提供了新的可靠选择。

As the largest organ of the human body, the skin is prone to be damaged, and its repair process can be challenging. Especially against the backdrop of chronic diseases and aging, the wound healing has become an increasingly prominent issue. Conventional wound management strategies are often limited by prolonged duration and high susceptibility to infection. In contrast, biological therapies emerging from the field of regenerative medicine have shown promising prospects. Mesenchymal stem cell-derived exosomes (MSC-Exos) have emerged as a safe and effective “cell-free” therapeutic approach, favored for their low immunogenicity, ease of storage, and quantifiability. They primarily facilitate skin wound repair through paracrine mechanisms. This review summarizes recent advances in the mechanistic actions, delivery methods, and clinical applications of MSC-Exos from various tissue sources in promoting skin wound healing.

Objective  To establish a physical standard for the first time for the standardized evaluation of ABO blood group genotyping detection.

Methods  Peripheral blood from volunteers with different ABO blood groups was collected to establish immortalized cell lines of ABO blood group. Following in vitro expansion, genomic DNA (gDNA) was extracted. The concentration was measured using Qubit, the purity was checked using Nanodrop spectrophotometer, and the integrity of the genome was analyzed by agarose gel electrophoresis. The gDNA samples that passed the quality inspection were grouped and prepared into the national reference panel for ABO blood type. The stability and uniformity of the reference panel were verified after resuspension.

Results  Thirteen immortalized cell lines of ABO blood groups were successfully established. The gDNA extracted from the cultured cells was prepared into the national reference panel for ABO blood groups. After three freeze-thaw cycles, the gDNA remained intact with satisfactory purity and uniformity. There was no significant change in DNA concentration before and after freeze-thawing, and the relative deviation was within ±10.0%.

Conclusion  The national reference panel for ABO blood group genotyping is successfully established, providing a physical standard for the quality evaluation of ABO blood group genotyping test kits.

Ferroptosis is a new form of cell death regulation different from typical cell death modes such as apoptosis, necrosis and autophagy, and more and more experimental studies have shown that ferroptosis plays an important role in the occurrence, development, migration and invasion of renal cell carcinoma. In recent years, traditional Chinese medicine (TCM) has shown unique advantages in renal cell carcinoma treatment due to its multi-targets, multi-pathways and low drug resistance, and is able to induce ferroptosis in renal cancer cells by regulating iron metabolism, lipid metabolism and antioxidant pathways. In this paper, we review the key regulators and signaling pathways of ferroptosis in renal cell carcinoma, summarize the studies on the induction of ferroptosis in renal cell carcinoma by TCM in recent years, and explore its potential mechanism of action, with a view to provide new ideas and methods for in-depth research on TCM in the treatment of renal cell carcinoma.

Preeclampsia is a severe pregnancy-specific condition characterized by inadequate trophoblast invasion and abnormal spiral artery remodeling, resulting in placental hypoperfusion, oxidative stress, endothelial dysfunction, and immune-inflammatory activation, leading to symptoms like hypertension and proteinuria. Mesenchymal stem cell-derived exosomes (MSC-Exos), nanoscale extracellular vesicles carrying mRNA, miRNA, and proteins, have emerged as promising therapeutic agents due to their angiogenic, anti-inflammatory, anti-apoptotic, and immunomodulatory properties. MSC-Exos have shown effectiveness in treating preeclampsia by enhancing eNOS signaling to improve vascular relaxation, reducing NOX1/4 expression to alleviate oxidative damage, activating ERK/MMP-2 pathways to enhance trophoblast invasion, balancing M1/M2 macrophage polarization to mitigate inflammation, and inhibiting ferroptosis via molecules like miR-3614-5p. Among MSC-Exos, those derived from umbilical cord sources are extensively studied due to their high yield and low immunogenicity, while exosomes from bone marrow and adipose tissue exhibit unique targeting effects in specific pathways. Challenges in this field include standardizing isolation methods, addressing source heterogeneity, and improving animal model fidelity. It is crucial to scale up production using bioreactors and engineering exosome targeting through surface modification to facilitate clinical translation.

Protein post-translational modification (PTM) plays an extraordinary role in biological processes such as mediating intercellular signal transduction, regulating the expression of cytokines, and activating various signaling pathways, and has a profound impact on the occurrence and development of diseases including tumors and inflammation. Many studies have reported that PTM plays a key role in the evolution of acute kidney injury (AKI) to chronic kidney disease (CKD) by inducing chronic renal inflammation, promoting cell apoptosis, changing organelle homeostasis, and aggravating renal fibrosis. In terms of mechanisms, protein post-translational modifications such as ubiquitination, phosphorylation, glycosylation, and acetylation affect the expression of downstream target genes and regulate signaling pathways including Wnt/β-catenin, Pink1/Parkin, TGF-β/Smad, NF-κB, etc., thus having an important impact on the progression of AKI to CKD. With the progress of relevant understanding and research on PTM in the evolution of AKI-CKD, it provides ideas for clinical prevention and treatment of the transformation from AKI to CKD.

为进一步探究科研类实验室安全管理绩效考核体系，推动科研类实验室安全管理成效，降低实验室风险。以科研类实验室特点及绩效考核现状为基础，从高层管理者、中层管理者和基层实验员三个层级，完善考核指标、构建考核办法。构建了 9 个一级指标和 40 个二级指标的科研类实验室绩效考核体系，通过权值因子判断表法计算各管理层级权重，明确考核流程和结果反馈机制，量化评价实验室安全管理效果，对科研类实验室的标准化管理具有指导意义。

Objective  To investigate the prevalence and risk factors for pulmonary nodules among individuals undergoing health check-ups in Foshan. The findings will provide valuable insights for the prevention and management of pulmonary diseases.

Methods  A total of 1515 healthy individuals who underwent pulmonary CT scans at the district chronic respiratory disease prevention and control center between March 2023 to October 2024 were included in this study. General demographic data, questionnaire responses, and CT imaging findings were collected. Logistic regression analysis was performed to assess the association between the prevalence of pulmonary nodule and various risk factors, including age, gender, smoking history, cooking fume exposure, occupational exposure, respiratory symptoms, and family history.

Results  Among the 1515 participants, pulmonary nodules were detected in 634 cases (41.85%), with 393 males and 241 females. The detection rate was significantly higher in males than in females (50.38% vs 32.79%, P < 0.05). Multivariate Logistic regression analysis identified male gender, older age, respiratory symptoms, occupational exposure, family history, smoking, and cooking fume exposure as independent risk factors for pulmonary nodules (P < 0.05).

Conclusion  The prevalence of pulmonary nodules in the healthy population undergoing physical examination in Foshan is notably high. The occurrence of these nodules is significantly associated with male sex, advanced age, smoking, cooking fume exposure, occupational exposure, respiratory symptoms, and family history. It is crucial to enhance early screening and intervention efforts for high-risk populations.

Objective  To investigate the correlation between microRNA-122 (miR-122), stimulator of interferon genes (STING) mRNA and antiviral treatment outcomes in patients with chronic hepatitis B (CHB).

Methods  264 CHB patients admitted to our hospital from January 2022 to October 2023 were enrolled. According to the different outcomes of antiviral treatment, they were divided into complete response group and incomplete response group. Baseline data, serum miR-122, and STING mRNA levels were statistically analyzed between the two groups. Additionally, the impact and predictive values of pre-treatment serum miR-122 and STING mRNA levels on treatment outcomes were evaluated, and the interaction between serum miR-122 and STING mRNA expression levels in influencing patients' treatment outcomes was further analyzed.

Results  The levels of HBV DNA, HBeAg, and HBsAg in the incomplete response group were significantly higher than those in the complete response group (P < 0.05). The expression levels of miR-122 and STING mRNA in the incomplete response group were significantly lower than those in the complete response group after 24 and 48 weeks of treatment (P < 0.05). Increases in serum miR-122 and STING mRNA levels were each independently associated with treatment outcomes (P < 0.05). The AUC of traditional factors combined with HBV DNA, HBeAg, and HBsAg was greater than that of traditional factors alone. Additionally, the AUC of novel factors combined with serum miR-122 and STING mRNA was greater than that of novel factors alone. Furthermore, the AUC of combined novel factors was significantly greater than that of the combined traditional factors (Z = 2.015, P = 0.044). The coexistence of low expression of serum miR-122 and STING mRNA increased the risk of incomplete response by 5.988 times (P < 0.05).

Conclusion  Serum miR-122 and STING mRNA expression levels in patients with CHB are closely associated with antiviral therapeutic outcomes, and thus hold promise as novel biomarkers for evaluating the efficacy of antiviral therapy in these patients.

Chimeric antigen receptor-T cell (CAR-T) therapy is a precise form of adoptive immunotherapy. Exosomes are vesicles released by cells, containing proteins, nucleic acids and lipids. Exosomes derived from CAR-T cells possess the characteristics of T cells, including tumor-toxicity activity and ability to target tumor cells. This makes them advantageous for drug delivery, allowing for the transportation of anti-tumor drugs, gene editing elements, as well as carrying mRNA and miRNA. Exosomes derived from CAR-T cells offer a safer and potentially more effective approach to cancer therapy. This article provides a review of the advancements and applications of exosomes derived from CAR-T cells in cancer therapy.

Allergic asthma is a common condition that has a significant impact on the daily lives and overall well-being of patients. The current standard of care primarily involves the use of inhaled hormone medications to alleviate symptoms. However, recent research has shifted its focus towards understanding the immune system's role in the development of asthma pathogenesis, highlighting the crucial influence of intestinal microorganisms within the "gut-lung axis". This article delves into the intricate mechanisms by which intestinal flora regulates allergic asthma, including its effects on the intestinal barrier, involvement in inflammatory processes within the intestinal mucosal immune system, and modulation of immune cells. Furthermore, a comprehensive review of current clinical research on probiotics and bacterial lysates is presented, aiming to provide valuable insights and impetus for future investigations into the treatment and management of allergic asthma.

Objective  To understand the epidemiological situation and etiological characteristics of influenza (abbreviated as flu) in Changning District of Shanghai between winter 2022 and spring 2023 so as to provide a basis for influenza prevention, control, early warning and monitoring.

Methods  Influenza-like illness (ILI) related data in Changning District,Shanghaifrom November 2022 to May 2023 were collected from China Influenza Surveillance System. R4.2.2software was used for statistical analysis. Fluorescent quantitative PCR was used for nucleic acid detection ofILIcase specimens. MDCK cytoviral isolation method was selected to isolate and culture influenza strains for whole genome sequencing, as well as analysis of the evolution of HA and NA genes and amino acid variation (to analyze the characteristics of HA and NA gene).

Results  During the winter and spring of 2022 - 2023, the fever clinic of medical institutions in Changning District experienced two waves of outpatient visit peaks, mainly caused by the alternate emergence of COVID-19 and influenza viruses. In the 1040 samples submitted for testing, the positive detection rate of influenza viruses in this round of monitoring was 31.06%, predominantly influenza A for 99.38%, of which H1N1 accounted for 81.93%, H3N2 accounted for 18.06%, and the rest were B Victoria series. During the monitoring period, the highest influenza positive rate was 42.86% (24/56) in adolescents (12 - 18 years old) with significant differences among different age groups (P < 0.001) while there was no significant difference between different genders

(χ² = 2.77, P = 0.096). Genetic sequencing revealed a high coincidence rate between the circulating influenza strains in this epidemic and the seasonal vaccine strains. Surveillance results for drug-resistant sites indicated no occurrence of resistance to neuraminidase inhibitors (NAIs).

Conclusion  The high matching degree between the vaccine strains and the circulating strains in this season suggests that the current vaccine protection effect is good and the risk of influenza pandemic is low in the near future. However, it is necessary to further strengthen multidimensional comprehensive surveillance and early warning to improve the scientific analysis of influenza epidemic trends.