BioTech最新文献 - Book学术

Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets. 细胞和基因治疗的监管趋同：协调FDA、EMA、PMDA和新兴市场的质量、CMC和批准途径。

IF 3.6

BioTech Pub Date : 2026-09-16 DOI: 10.3390/biotech15040079

Nagendra Verma, Swati Arora

{"title":"Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.","authors":"Nagendra Verma, Swati Arora","doi":"10.3390/biotech15040079","DOIUrl":"10.3390/biotech15040079","url":null,"abstract":"Cell and gene therapies (CGTs) have progressed from proof of concept to an established commercial pipeline, yet global translation remains constrained by fragmented regulatory frameworks; heterogeneous Chemistry, Manufacturing, and Controls (CMC) requirements; and divergent approval pathways. This narrative review compares CGT quality, CMC, and approval-pathway regulation across the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), together with five emerging-market agencies: Brazil, Russia, India, China, and Mexico (BRIC-M), current to June 2026. Four convergence gaps recur across all eight jurisdictions: unstandardized potency assay validation, inconsistent post-change comparability expectations, uneven ICH guideline implementation, and divergent evidentiary thresholds for small-population trials. Convergence readiness varies sharply within the emerging-market group, from ICH Regulatory Membership and internationally benchmarked CMC guidance in China and Brazil to reference-country reliance in Mexico and observer status in Russia and India. On this basis, we propose the Global CGT Regulatory Convergence Framework (GCRC-F), a reference architecture of four independently adoptable pillars: (i) Unified CMC Standards, (ii) a Data Harmonization Layer for long-term follow-up and real-world evidence, (iii) an Adaptive Approval Layer linking accelerated designations across agencies, and (iv) a Manufacturing Standardization Layer that is built on existing regulatory precedents rather than novel instruments, with participation tiered by demonstrated regulatory-science maturity. The framework is offered as a structured proposal for discussion; it has not been evaluated by regulators or industry stakeholders, and its feasibility remains to be tested through the consultation and case-study methods identified.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Engineering of Surface Display Systems in E. coli for Recombinant Protein Production. 用于重组蛋白生产的大肠杆菌表面显示系统工程。

IF 3.6

BioTech Pub Date : 2026-09-15 DOI: 10.3390/biotech15040078

Olga S Kostareva, Polina I Blinova, Svetlana V Tishchenko, Ilya A Kolyadenko, Anatoly S Glukhov, Irina A Eliseeva, Alisa O Mikhaylina

{"title":"Engineering of Surface Display Systems in E. coli for Recombinant Protein Production.","authors":"Olga S Kostareva, Polina I Blinova, Svetlana V Tishchenko, Ilya A Kolyadenko, Anatoly S Glukhov, Irina A Eliseeva, Alisa O Mikhaylina","doi":"10.3390/biotech15040078","DOIUrl":"10.3390/biotech15040078","url":null,"abstract":"Isolation of various groups of protein preparations is a crucial task in many areas of biochemical research. Creating an effective, simple and economically feasible system for recombinant protein production is highly valuable for both basic research and applied biotechnology. Most laboratory studies focus on bacterial systems for heterologous gene expression. However, such systems can encounter major difficulties with target proteins that have specific properties. Some proteins can aggregate, form insoluble inclusion bodies or undergo proteolytic cleavage during overproduction. Moreover, they can be toxic, and thus adversely affect the host cell when overproduced. These issues can be circumvented by using cellular secretion systems to export the target protein from the cell during production. The present study compares three established systems for exporting target proteins to the bacterial cell surface. Three model proteins were selected: the cytokine IL-17A, the catalytic domain of TEV protease, and the calcium-binding domain of nucleobindin 1. Three protein export systems were used: the first was based on the E. coli outer membrane OmpA protein, the second on the E. coli Ag43 autotransporter of the AIDA-I family, and the third on the INP of Pseudomonas syringae. Recombinant proteins were cleaved by site-directed chemical proteolysis.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Long-Term Labeling and Differentiation Monitoring of Mouse Spermatogonial Stem Cells Using CellREADR. 利用CellREADR对小鼠精原干细胞进行长期标记和分化监测。

IF 3.6

BioTech Pub Date : 2026-09-08 DOI: 10.3390/biotech15040077

Shuaitao Hu, Lin Yan, Gulistan Khan, Xiaowei Liu, Chunsheng Han

{"title":"Long-Term Labeling and Differentiation Monitoring of Mouse Spermatogonial Stem Cells Using CellREADR.","authors":"Shuaitao Hu, Lin Yan, Gulistan Khan, Xiaowei Liu, Chunsheng Han","doi":"10.3390/biotech15040077","DOIUrl":"10.3390/biotech15040077","url":null,"abstract":"Cellular identity determination and lineage tracing is a pivotal technique in modern biological research. Conceptually simple yet efficient cell labeling techniques offering broader applicability are warranted despite many methods requiring intricate construction procedures. One such technique is ADAR (adenosine deaminase acting on RNA)-mediated RNA sensing, a live cell labeling technique that is based on the expression and abundance of cell-type-specific RNAs. Here, we utilized the optimized version, CellREADR (Cell access through RNA sensing by Endogenous ADAR), to establish a feasible tracing system for mouse spermatogonial stem cells (mSSCs) which are refractory to CRISPR-based reporter gene knock-in. We identified several previously unreported features of CellREADR, including RNA interference induced by double-strand RNA formation that is obligatorily generated during the normal operation of the CellREADR system. More importantly, we established its application for long-term labeling of mSSCs and monitoring mSSC differentiation induced by retinoic acid (RA) treatment in vitro. This work offers a practical solution for dynamic monitoring of mSSC self-renewal and differentiation and supports that CellREADR can be developed into more versatile and efficient tools in stem cell research.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600034/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Co-Directional Chromosomal Clustering of Metabolic Pathway Genes as a Layout Prior for Synthetic Construct Design. 代谢途径基因的共向染色体聚类作为合成结构设计的布局先验。

IF 3.6

BioTech Pub Date : 2026-09-03 DOI: 10.3390/biotech15040075

Xiaowei Han, Zhixu Qiu, Jiani Hu, Jie Song

{"title":"Co-Directional Chromosomal Clustering of Metabolic Pathway Genes as a Layout Prior for Synthetic Construct Design.","authors":"Xiaowei Han, Zhixu Qiu, Jiani Hu, Jie Song","doi":"10.3390/biotech15040075","DOIUrl":"10.3390/biotech15040075","url":null,"abstract":"Metabolic pathway design tools largely address reaction routes and enzyme choice, whereas a complementary set of questions-how pathway genes are arranged on bacterial chromosomes and whether co-directional neighborhoods can inform multi-gene construct layout-has received comparatively little systematic treatment. Here, we present SynPAL (Synteny-Informed Pathway Assembly and Layout), a computational analysis that scores co-directional clustering of BioCyc pathway genes from genomic coordinates (same replicon and strand, intergenic distance ≤ 2000 bp) and translates the resulting scores into design-oriented hypotheses. On a core panel of 55 prokaryotes (887 analyzable pathways), medium or high clustering occurs for 290 pathways (32.7%), with a mean cluster score of 0.432 versus 0.262 under an organism-matched random-gene-set null; 692/887 pathways remain significant after Benjamini-Hochberg false-discovery-rate control at q<0.05. High scores recover classical operons, including nan, bkd, pdxST, and gmd-fcl, under a fixed labeling protocol. Scoring gene-name order in pathway tables instead of coordinates yields substantially higher medium/high rates on the same pathways (80.1% vs. 32.0% on the full 55-organism panel; 90.5% vs. 49.2% on a paired 63-pathway set) and correlates only weakly with coordinate scores (Pearson's r=0.23), demonstrating that table order is not chromosomal synteny. Pathways are assigned design-readiness tiers T1-T4 as layout hypotheses, and sequence-backed construct drafts were generated for 222 of 224 T1 pathways. An expanded survey of 9071 prokaryotic databases (1629 pathways) shows a similar selective landscape (42.7% medium/high). SynPAL does not select enzymes, predict flux, or report wet-lab expression; it supplies coordinate-based cluster scores, tiers, and draft layouts that can accept a gene list from reaction-network CAD tools.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Utilization of Guarana Agroindustrial Waste as a Source of Antimicrobial Compounds for Human Pathogenic Bacterial Removal in Wastewater Sample. 瓜拉那农业工业废水中抗菌化合物去除人类致病菌的研究

IF 3.6

BioTech Pub Date : 2026-09-03 DOI: 10.3390/biotech15040076

Erickson Oliveira Dos Santos, Cleideane Cunha Costa, Pedro Luis Sosa Gonzáles, Priscila Pauly Ribas, Carla Estefani Batista

{"title":"Utilization of Guarana Agroindustrial Waste as a Source of Antimicrobial Compounds for Human Pathogenic Bacterial Removal in Wastewater Sample.","authors":"Erickson Oliveira Dos Santos, Cleideane Cunha Costa, Pedro Luis Sosa Gonzáles, Priscila Pauly Ribas, Carla Estefani Batista","doi":"10.3390/biotech15040076","DOIUrl":"10.3390/biotech15040076","url":null,"abstract":"The guarana seed peel (GSP), an agroindustrial waste, was characterized for its chemical composition and evaluated for its antimicrobial activity as a potential source of antibacterial compounds for wastewater disinfection using UPLC-QTOF-MS analysis. UPLC-QTOF-MS analysis of GSP, its raw extract (GSPE), and its purified extract (GSPP) identified 36 compounds, including catechin and its oligomers: a B-type procyanidin dimer, pavetannin B6 (trimer), and cinnamtannin A2 (tetramer). Principal component analysis (PCA) separated GSPE from GSPP along PC2, and the purification step concentrated flavonoids-mainly catechin and its oligomers-in GSPP. Antimicrobial activity was assessed against the human pathogens Escherichia coli and Salmonella typhimurium, causing gastroenteritis and invasive disease, and Staphylococcus aureus, causing skin and invasive infections. In real wastewater, GSPE (500 mg L-1) reduced total coliforms by up to 81 ± 7% and E. coli by up to 74 ± 7% within 180 min. Confocal microscopy with the LIVE/DEAD® BacLight™ kit (Thermo Fhisher, Eugene, OR, USA) confirmed loss of membrane integrity in GSPE-treated Escherichia coli, and disc diffusion with GSPP produced inhibition zones of 9-11 mm against Staphylococcus aureus, Escherichia coli and Salmonella typhimurium at 5 mg per disc. These results show that guarana seed peel-currently discarded-is a viable source of catechin-rich antibacterial extracts for wastewater disinfection.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Rational Design of Aspergillus awamori Glucoamylase for Activity Improvement. 提高青曲霉葡萄糖淀粉酶活性的合理设计。

IF 3.6

BioTech Pub Date : 2026-09-02 DOI: 10.3390/biotech15040074

Anna Dotsenko, Nikita Eroshenko, Ekaterina Rubtsova, Aleksandra Rozhkova, Ivan Zorov, Arkady Sinitsyn

{"title":"Rational Design of Aspergillus awamori Glucoamylase for Activity Improvement.","authors":"Anna Dotsenko, Nikita Eroshenko, Ekaterina Rubtsova, Aleksandra Rozhkova, Ivan Zorov, Arkady Sinitsyn","doi":"10.3390/biotech15040074","DOIUrl":"10.3390/biotech15040074","url":null,"abstract":"Glucoamylases are highly demanded by the industry for starch saccharification, which necessitates an increase in enzyme activity. To improve the activity of Aspergillus awamori VKPM F-1262 glucoamylase N181Q (AGAM), amino acid substitutions were made in the region of substrate binding. In the case of the variant D237G, there was a 1.3-1.4-fold increase in activity towards soluble starch for the individual enzyme and crude enzyme solution after cultivation in flasks. For the variants G57A and C319T, there was also a 1.1-1.4-fold increase in enzyme activity for the crude flask solution, while the increase in individual enzyme activity was minor. AGAM showed an increase in apparent molecular weight consistent with dimerization in the presence of soluble starch. A high T optimum of 70 °C was observed for AGAM and the variants in the hydrolysis of soluble starch. In further protein engineering, a high T optimum for hydrolysis, which may coincide with dimerization, may be considered as a hypothesis for the selection of thermostable glucoamylases, while an area of binding of oligo- and polysaccharides may be a site for mutagenesis.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Whole Genome Sequencing of the Moruga Hill Rice (Oryza glaberrima) Reveals Its African Ancestry and the Presence of Candidate Stress-Tolerance Genes. Moruga Hill Rice （Oryza glaberrima）的全基因组测序揭示了其非洲血统和候选抗逆性基因的存在。

IF 3.6

BioTech Pub Date : 2026-08-25 DOI: 10.3390/biotech15040073

Uddesh M Sahadeo, Omar Ali, Adesh Ramsubhag, Christine Carrington, Arianne Brown Jordan, Jayaraj Jayaraman

{"title":"Whole Genome Sequencing of the Moruga Hill Rice (Oryza glaberrima) Reveals Its African Ancestry and the Presence of Candidate Stress-Tolerance Genes.","authors":"Uddesh M Sahadeo, Omar Ali, Adesh Ramsubhag, Christine Carrington, Arianne Brown Jordan, Jayaraj Jayaraman","doi":"10.3390/biotech15040073","DOIUrl":"10.3390/biotech15040073","url":null,"abstract":"Moruga Hill Rice (MHR) is an African rice (Oryza glaberrima Steud.) brought to Trinidad by formerly enslaved African Americans and has been grown for many generations in Trinidad at subsistence and commercial scale. Despite its historical and agricultural significance, genomic resources specific to MHR remain unexplored, and its genetic composition, evolutionary history, and potential agronomic traits have not been characterized. This current study presents the first draft genome assembly of the MHR genome using a hybrid sequencing approach. The MHR genome size was found to be ~372.9 Mb with 56,073 predicted genes. Variant analysis revealed a total of 3,318,242 variants, of which 2,440,476 were SNPs, and 877,766 were InDels. Several candidate genes encoding proteins with orthology to previously characterized biotic resistance and abiotic stress-responsive genes in rice were identified. Potential gene families identified prompt further investigation of their roles in MHR drought and salt stress responses. Phylogenomic analysis of O. glaberrima landraces suggests that MHR shares close genetic affinity with the IRGC-104595 Malian landrace, consistent with historical records. This assembly thus expands the African rice genomic repository, providing a foundation to understand the genetic architecture underlying key phenotypic traits and identifying potential novel gene sources in MHR for rice improvement in the Caribbean region.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Bacteriophages 6phi8, 6phi10, and 6phi13 Isolated from the Therapeutic Cocktail "Sextaphag^®". 从治疗鸡尾酒“Sextaphag®”中分离的噬菌体6phi8、6phi10和6phi13。

IF 3.6

BioTech Pub Date : 2026-08-24 DOI: 10.3390/biotech15040072

Vladislav Kulyabin, Andrey Shadrin

{"title":"Bacteriophages 6phi8, 6phi10, and 6phi13 Isolated from the Therapeutic Cocktail \"Sextaphag®\".","authors":"Vladislav Kulyabin, Andrey Shadrin","doi":"10.3390/biotech15040072","DOIUrl":"10.3390/biotech15040072","url":null,"abstract":"The present study provides the physicochemical and genomic characterization of three Escherichia bacteriophages (6phi8, 6phi10, and 6phi13) isolated from the commercial phage preparation \"Sextaphag®\". For each bacteriophage, lytic activity against E. coli MG1655, as well as pH and thermal stability, were determined. Whole-genome sequencing was performed, followed by bioinformatic annotation and comparative genomic analysis. Bacteriophages 6phi8 and 6phi13 belong to the T4-like myoviruses with large genomes (~169 and ~171 kb, respectively), whereas 6phi10 is a T7-like podovirus with a genome size of 40.1 kb. Phage 6phi8 was assigned to the genus Mosigvirus of the family Straboviridae, 6phi13 was classified within the genus Tequatrovirus of the same family, and 6phi10 was identified as a putative novel species of the genus Berlinvirus within the family Autotranscriptaviridae. The genomes of the studied phages lack genes associated with the lysogenic cycle, as well as virulence and antibiotic resistance determinants. The results expand current knowledge of the genomic properties of phages included in therapeutic cocktails and may contribute to the development of phage preparations against infections caused by E. coli and other members of the family Enterobacteriaceae.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 4","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600099/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Optimizing MatB-MatC-Dependent Malonyl-CoA Supply for Enhanced Raspberry Ketone Production in Escherichia coli. 优化matb - matc依赖性丙二酚辅酶a供应以提高大肠杆菌树莓酮的产量。

IF 3.6

BioTech Pub Date : 2026-08-21 DOI: 10.3390/biotech15030071

Kurumi Usui, Naoki Takaya, Shunsuke Masuo

{"title":"Optimizing MatB-MatC-Dependent Malonyl-CoA Supply for Enhanced Raspberry Ketone Production in Escherichia coli.","authors":"Kurumi Usui, Naoki Takaya, Shunsuke Masuo","doi":"10.3390/biotech15030071","DOIUrl":"10.3390/biotech15030071","url":null,"abstract":"Raspberry ketone (RK) is a valuable natural flavor compound, but its extraction from plants is inefficient because of its low natural abundance. Microbial production of RK offers a promising alternative; however, insufficient availability of malonyl-CoA can limit RK biosynthesis. In this study, we introduced a malonate-dependent malonyl-CoA supply module into an engineered Escherichia coli strain designed for de novo RK production through heterologous expression of malonyl-CoA synthetase MatB and malonate transporter MatC. In the presence of malonate, the introduction of the MatB-MatC module increased RK production by 2.3-fold. To optimize malonate supplementation, RK pathway metabolites, including intracellular acyl-CoA intermediates, were quantified by liquid chromatography-mass spectrometry, and the resulting metabolite profiles were analyzed by principal component analysis, hierarchical clustering, and correlation analysis. This study indicated that 50-mM malonate was optimal, yielding 24 mg/L RK during 96-deep-well plate cultivation. Fed-batch optimization increased RK production to 301 mg/L in a 100-mL jar fermenter, and scale-up cultivation in a 2-L jar fermenter produced 340 mg/L RK. In this study, optimizing MatB-MatC-dependent malonyl-CoA supply, combined with pathway-level metabolic profiling and controlled fed-batch cultivation, enhanced de novo RK production in E. coli.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 3","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13511146/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148833199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of Quality Normative Requirements: Contributions to the Alignment and Standardization of Standards Applied in Health Laboratories. 质量规范要求的分析：对卫生实验室应用标准的校准和标准化的贡献。

IF 3.6

BioTech Pub Date : 2026-08-19 DOI: 10.3390/biotech15030069

Saada L C Fernandez, Katharine V S Hodel, Renata Almeida de Souza, Hayna Malta-Santos, Camila Duarte Ferreira Ribeiro, Bruna A S Machado

{"title":"Analysis of Quality Normative Requirements: Contributions to the Alignment and Standardization of Standards Applied in Health Laboratories.","authors":"Saada L C Fernandez, Katharine V S Hodel, Renata Almeida de Souza, Hayna Malta-Santos, Camila Duarte Ferreira Ribeiro, Bruna A S Machado","doi":"10.3390/biotech15030069","DOIUrl":"10.3390/biotech15030069","url":null,"abstract":"The implementation of Quality Management Standards (QMS) in health laboratories is essential to ensuring the traceability, reliability, and reproducibility of results, thus supporting compliance and continuous improvement. This study identifies and compares the requirements adopted in four widely used four standards for health laboratoriesto evaluate their equivalence and contribute to the harmonization of normative terminology. A comparative analysis of the requirements and their applications in health laboratories was conducted. Subsequently, interrelationships and equivalence among the standards were assessed, followed by an evaluation of the terminology used and the grouping of requirements across the four normative documents. The results revealed a substantial overlap among the standards, particularly regarding quality management, risk management, personnel competence, documentation control, and continuous improvement. However, differences in terminology, structure, and scope were identified, which may hinder the uniform interpretation and implementation of quality systems. The harmonization of terms and equivalent requirements could facilitate compliance, integration of management systems, and accreditation processes. The findings demonstrate that standardizing normative terminology contributes to greater alignment among quality standards, improving their understanding, dissemination, and application in health laboratories while supporting more efficient and reliable quality management practices.","PeriodicalId":34490,"journal":{"name":"BioTech","volume":"15 3","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13510525/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148832976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0