Biotechnology Reports最新文献_第9页

Deciphering the antimicrobial, antibiofilm and membrane stabilizing synergism of Mikania scandens (L.) Willd. leaves and stems substantiation through in vitro and in silico studies 解析薇甘菊的抗菌、抗菌膜和膜稳定协同作用。通过体外和计算机研究证实叶和茎

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00797

Nadia Islam Tumpa , Md. Helal Uddin Chowdhury , Ankhy Alamgir Asma

{"title":"Deciphering the antimicrobial, antibiofilm and membrane stabilizing synergism of Mikania scandens (L.) Willd. leaves and stems substantiation through in vitro and in silico studies","authors":"Nadia Islam Tumpa , Md. Helal Uddin Chowdhury , Ankhy Alamgir Asma","doi":"10.1016/j.btre.2023.e00797","DOIUrl":"https://doi.org/10.1016/j.btre.2023.e00797","url":null,"abstract":"<div>Considering the traditional application of Mikania scandens (L.) Willd. against wounds and itching. Leaves (MSL) and stems (MSS) were sequentially extracted using solvents petroleum-ether, carbon-tetrachloride, chloroform, ethyl-acetate and ethanol. Disk-diffusion assay revealed the ethyl acetate MSL and MSS extracts were the prominent against ten bacteria, five carbapenem-resistant bacteria and one fungal strains. Subsequent quantitative antimicrobial analysis specified MSL extractives more potent over MSS with lower 1500 and 3500µg/ml MIC and MBC value in both gram-negative and positive bacteria. These sturdiest ethyl-acetate MSL extractives antimicrobial efficiency also fostered fungicidal activity having lower 100µg/ml MFC. Whereat, almost homologous 160–180 min timing noted liken to standard ciprofloxacin susceptibility in both strains, 75% biofilm inhibition at 2×MIC concentration along with 92±0.2% membrane stabilizing activities over synthetic counterparts prospected in preceding standard extractives. Computational molecular docking of MSL compounds supported this findings therefore forego this valuable synergistic insight as antimicrobial agents to efficiently eradicate human infections.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00797"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50176512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Overexpression of quorum sensing genes in Acidithiobacillus ferrooxidans enhances cell attachment and covellite bioleaching 群体感应基因在氧化亚铁酸硫杆菌中的过表达增强了细胞附着和海湾生物浸出

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00789

Heejung Jung, Yuta Inaba, Alan C. West, Scott Banta

{"title":"Overexpression of quorum sensing genes in Acidithiobacillus ferrooxidans enhances cell attachment and covellite bioleaching","authors":"Heejung Jung, Yuta Inaba, Alan C. West, Scott Banta","doi":"10.1016/j.btre.2023.e00789","DOIUrl":"https://doi.org/10.1016/j.btre.2023.e00789","url":null,"abstract":"<div>Cell adhesion is generally a prerequisite to the microbial bioleaching of sulfide minerals, and surface biofilm formation is modulated via quorum sensing (QS) communication. We explored the impact of the overexpression of endogenous QS machinery on the covellite bioleaching capabilities of Acidithiobacillus ferrooxidans, a representative acidophilic chemolithoautotrophic bacterium. Cells were engineered to overexpress the endogenous qs-I operon or just the afeI gene under control of the tac promoter. Both strains exhibited increased transcriptional gene expression of afeI and improved cell adhesion to covellite, including increased production of extracellular polymeric substances and increased biofilm formation. Under low iron conditions, the improved bioleaching of covellite was more evident when afeI was overexpressed alone as compared to the native operon. These observations demonstrate the potential for the genetic modulation of QS as a mechanism for increasing the bioleaching efficiency of covellite, and potentially other copper sulfide minerals.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00789"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50176572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Immunogenic fusion proteins induce neutralizing SARS-CoV-2 antibodies in the serum and milk of sheep 免疫原性融合蛋白在绵羊血清和乳汁中诱导中和性严重急性呼吸系统综合征冠状病毒2型抗体

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00791

Gregory M. Jacobson , Kirsty Kraakman , Olivia Wallace , Jolyn Pan , Alex Hennebry , Grant Smolenski , Ray Cursons , Steve Hodgkinson , Adele Williamson , William Kelton

{"title":"Immunogenic fusion proteins induce neutralizing SARS-CoV-2 antibodies in the serum and milk of sheep","authors":"Gregory M. Jacobson , Kirsty Kraakman , Olivia Wallace , Jolyn Pan , Alex Hennebry , Grant Smolenski , Ray Cursons , Steve Hodgkinson , Adele Williamson , William Kelton","doi":"10.1016/j.btre.2023.e00791","DOIUrl":"10.1016/j.btre.2023.e00791","url":null,"abstract":"<div>Antigen-specific polyclonal immunoglobulins derived from the serum, colostrum, or milk of immunized ruminant animals have potential as scalable therapeutics for the control of viral diseases including COVID-19. Here we show that the immunization of sheep with fusions of the SARS-CoV-2 receptor binding domain (RBD) to ovine IgG2a Fc domains promotes significantly higher levels of antigen-specific antibodies compared to native RBD or full-length spike antigens. This antibody population contained elevated levels of neutralizing antibodies that suppressed binding between the RBD and hACE2 receptors in vitro. A second immune-stimulating fusion candidate, Granulocyte-macrophage colony-stimulating factor (GM-CSF), induced high neutralizing responses in select animals but narrowly missed achieving significance. We further demonstrated that the antibodies induced by these fusion antigens were transferred into colostrum/milk and possessed cross-neutralizing activity against diverse SARS-CoV-2 variants. Our findings highlight a new pathway for recombinant antigen design in ruminant animals with applications in immune milk production and animal health.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00791"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bc/8f/main.PMC9995299.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9239184","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: 1

Therapeutic efficacy of plant-produced Nivolumab in transgenic C57BL/6-hPD-1 mouse implanted with MC38 colon cancer 植物性尼沃单抗对MC38结肠癌细胞移植的转基因C57BL/6-hPD-1小鼠的治疗效果

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00794

Christine Joy I. Bulaon , Hongyan Sun , Ashwini Malla , Waranyoo Phoolcharoen

{"title":"Therapeutic efficacy of plant-produced Nivolumab in transgenic C57BL/6-hPD-1 mouse implanted with MC38 colon cancer","authors":"Christine Joy I. Bulaon , Hongyan Sun , Ashwini Malla , Waranyoo Phoolcharoen","doi":"10.1016/j.btre.2023.e00794","DOIUrl":"10.1016/j.btre.2023.e00794","url":null,"abstract":"<div>The therapeutic blockade of inhibitory PD-1 signaling has emerged as an effective approach for cancer immunotherapy. Nivolumab (Opdivo®), a monoclonal antibody (mAb) targeting the PD-1 immune checkpoint, is approved for treatment of several cancer indications. It functions by blocking the PD-1-mediated T-cell inhibition thus reinstating anticancer immune responses. Tremendous advances in plant biotechnology offer an alternative and economical strategy to produce therapeutic mAbs for immune-based therapies. In this study, recombinant anti-PD-1 Nivolumab was produced in Nicotiana benthamiana and the plant-produced anti-PD-1 mAb was exploited for cancer treatment in syngeneic mice model C57BL/6 mice that were used to test the antitumor efficacy of plant produced Nivolumab, along with commercial Opdivo®. C57BL/6 syngeneic mice treated with plant produced anti-PD-1 mAb exhibited reduction in the growth of established MC38 tumors. The plant produced Nivolumab treatment showed 82.9% antitumor effect in decreasing the tumor volume along with 50% tumor-free mice, whereas Opdivo® showed 90.26% reduction in volume without any tumor-free mice. Finally, plant-derived anti-PD-1 therapy was also well tolerated in tumor-bearing mice that correlated with no significant body weight changes. Overall, our plant-produced Nivolumab elicits significant inhibition of tumor growth in vivo and provides a proof-of-concept for the production of immunotherapy targeting PD-1.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00794"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10090705/pdf/main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9317900","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

Antiviral activity of red algae phycocolloids against herpes simplex virus type 2 in vitro 红藻类藻类对单纯疱疹病毒2型的体外抗病毒活性

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00798

Adolfo Henríquez , Juan Pablo Vargas , Chris Landahur , Nicolás Corrales , Andrés Agurto-Muñoz , Pablo A. González , Cristian Agurto-Muñoz

{"title":"Antiviral activity of red algae phycocolloids against herpes simplex virus type 2 in vitro","authors":"Adolfo Henríquez , Juan Pablo Vargas , Chris Landahur , Nicolás Corrales , Andrés Agurto-Muñoz , Pablo A. González , Cristian Agurto-Muñoz","doi":"10.1016/j.btre.2023.e00798","DOIUrl":"https://doi.org/10.1016/j.btre.2023.e00798","url":null,"abstract":"<div>Herpes simplex virus type 2 (HSV-2) is a human infectious agent with significant impact on public health due to its high prevalence in the population and its ability to elicit a wide range of diseases, from mild to severe. Although several antiviral drugs, such as acyclovir, are currently available to treat HSV-2-related clinical manifestations, their effectiveness is poor. Therefore, the identification and development of new antiviral drugs against HSV-2 is necessary. Seaweeds are attractive candidates for such purposes because they are a vast source of natural products due to their highly diverse compounds, many with demonstrated biological activity. In this study, we evaluated the in vitro antiviral potential of red algae extracts obtained from Agarophyton chilense, Mazzaella laminarioides, Porphyridium cruentum, and Porphyridium purpureum against HSV-2. The phycocolloids agar and carrageenan obtained from the macroalgae dry biomass of A. chilense and M. laminarioides and the exopolysaccharides from P. cruentum and P. purpureum were evaluated. The cytotoxicity of these extracts and the surpluses obtained in the extraction process of the agar and carrageenans were evaluated in human epithelial cells (HeLa cells) in addition to their antiviral activity against HSV-2, which were used to calculate selectivity indexes (SIs). Several compounds displayed antiviral activity against HSV-2, but carrageenans were not considered as a potential antiviral therapeutic agent when compared to the other algae extracts with a SI of 23.3. Future assays in vivo models for HSV-2 infection should reveal the therapeutic potential of these algae compounds as new antivirals against this virus.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00798"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50176510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Corrigendum to Comparative computational study to augment UbiA prenyltransferases inherent in purple photosynthetic bacteria cultured from mangrove microbial mats in Qatar for coenzyme Q10 biosynthesis 增加卡塔尔红树林微生物垫培养的紫色光合细菌固有的UbiA异戊二烯基转移酶用于辅酶Q10生物合成的比较计算研究更正

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00793

Drishya M. George , Ramya Ramadoss , Hamish R. Mackey , Annette S. Vincent

引用次数: 0

Probiotics and their postbiotics for the control of opportunistic fungal pathogens: A review 益生菌及其后生物素用于控制机会性真菌病原体：综述

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00800

S. Divyashree, B. Shruthi, P.R. Vanitha, M.Y. Sreenivasa

{"title":"Probiotics and their postbiotics for the control of opportunistic fungal pathogens: A review","authors":"S. Divyashree, B. Shruthi, P.R. Vanitha, M.Y. Sreenivasa","doi":"10.1016/j.btre.2023.e00800","DOIUrl":"10.1016/j.btre.2023.e00800","url":null,"abstract":"<div>During past twenty years the opportunistic fungal infections have been emerging, causing morbidity and mortality. The fungi belonging to Aspergillus, Mucor, Rhizopus, Candida, Fusarium, Penicillium, Dermatophytes and others cause severe opportunistic fungal infections. Among these Aspergillus and Candida spp cause majority of the diseases. The continuum of fungal infections will prolong to progress in the surroundings of the growing inhabitants of immunocompromised individuals. Presently many chemical-based drugs were used as prophylactic and therapeutic agents. Prolonged usage of antibiotics may lead to some severe effect on the human health. Also, one of the major threats is that the fungal pathogens are becoming the drug resistant. There are many physical, chemical, and mechanical methods to prevent the contamination or to control the disease. Owing to the limitations that are observed in such methods, biological methods are gaining more interest because of the use of natural products which have comparatively less side effects and environment friendly. In recent years, research on the possible use of natural products such as probiotics for clinical use is gaining importance. Probiotics, one of the well studied biological products, are safe upon consumption and are explored to treat various fungal infections. The antifungal potency of major groups of probiotic cultures such as Lactobacillus spp, Leuconostoc spp, Saccharomyces etc. and their metabolic byproducts which act as postbiotics like organic acids, short chain fatty acids, bacteriocin like metabolites, Hydrogen peroxide, cyclic dipeptides etc. to inhibit these opportunistic fungal pathogens have been discussed here.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00800"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/49/ba/main.PMC10196798.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9859390","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: 1

Molecular background of HAC1-driven improvement in the secretion of recombinant protein in Yarrowia lipolytica based on comparative transcriptomics 基于比较转录组学的HAC1驱动的解脂亚罗维亚重组蛋白分泌改善的分子背景

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00801

Paulina Korpys-Woźniak, Ewelina Celińska

{"title":"Molecular background of HAC1-driven improvement in the secretion of recombinant protein in Yarrowia lipolytica based on comparative transcriptomics","authors":"Paulina Korpys-Woźniak, Ewelina Celińska","doi":"10.1016/j.btre.2023.e00801","DOIUrl":"https://doi.org/10.1016/j.btre.2023.e00801","url":null,"abstract":"<div>While the unfolded protein response (UPR) and its major regulator – transcription factor Hac1 are well-conserved across Eukarya, species-specific variations are repeatedly reported. Here we investigated molecular mechanisms by which co-over-expression of HAC1 improves secretion of a recombinant protein (r-Prot) in Yarrowia lipolytica, using comparative transcriptomics. Co-over-expression of HAC1 caused an >2-fold increase in secreted r-Prot, but its intracellular levels were decreased. The unconventional splicing rate of the HAC1 mRNA was counted through transcript sequencing. Multiple biological processes were affected in the HAC1-and-r-Prot co-over-expressing strain, including ribosome biogenesis, nuclear and mitochondrial events, cell cycle arrest, attenuation of gene expression by RNA polymerase III and II, as well as modulation of proteolysis and RNA metabolism; but whether the HAC1 co-over-expression/induction was the actual causative agent for these changes, was not always clear. We settled that the expression of the “conventional” HAC1 targets (KAR2 and PDI1) is not affected by its over-expression.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00801"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50176511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Extraction and characterization of bioactive secondary metabolites from lactic acid bacteria and evaluating their antifungal and antiaflatoxigenic activity 乳酸菌生物活性次级代谢产物的提取、表征及其抗真菌和抗氧化活性评价

Biotechnology Reports Pub Date : 2023-06-01 DOI: 10.1016/j.btre.2023.e00799

Aya Abdel-Nasser , Amal S. Hathout , Ahmed N. Badr , Olfat S. Barakat , Hayam M. Fathy

{"title":"Extraction and characterization of bioactive secondary metabolites from lactic acid bacteria and evaluating their antifungal and antiaflatoxigenic activity","authors":"Aya Abdel-Nasser , Amal S. Hathout , Ahmed N. Badr , Olfat S. Barakat , Hayam M. Fathy","doi":"10.1016/j.btre.2023.e00799","DOIUrl":"10.1016/j.btre.2023.e00799","url":null,"abstract":"<div>Aflatoxins are toxic carcinogens and mutagens formed by some moulds, specifically Aspergillus spp. Therefore, this study aimed to extract and identify bioactive secondary metabolites from Lactobacillus species, to evaluate their efficacy in reducing fungal growth and aflatoxin production and to investigate their toxicity. The bioactive secondary metabolites of Lactobacillus species showed variable degrees of antifungal activity, whereas L. rhamnosus ethyl acetate extract No. 5 exhibited the highest antifungal activity and, thus, was selected for further identification studies. Data revealed that L. rhamnosus ethyl acetate extract No. 5 produced various organic acids, volatile organic compounds and polyphenols, displayed antifungal activity against A. flavus, and triggered morphological changes in fungal conidiophores and conidiospores. L. rhamnosus ethyl acetate extract No. 5 at a 9 mg/mL concentration reduced AFB1 production by 99.98%. When the effect of L. rhamnosus ethyl acetate extract No. 5 on brine shrimp mortality was studied, the extract attained a 100% mortality at a concentration of 400 µg/mL, with an IC50 of 230 µg/mL. Meanwhile, a mouse bioassay was performed to assess the toxicity of L. rhamnosus ethyl acetate extract No. 5, whereas there were no harmful effects or symptoms in mice injected with L. rhamnosus ethyl acetate extract at concentrations of 1, 3, 5, 7, and 9 mg/kg body weight.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"38 ","pages":"Article e00799"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4a/b8/main.PMC10189384.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9551563","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: 2

Characterization of human induced pluripotent stems cells: Current approaches, challenges, and future solutions 人类诱导多能干细胞的特性：当前的方法、挑战和未来的解决方案

Biotechnology Reports Pub Date : 2023-03-01 DOI: 10.1016/j.btre.2023.e00784

Sahana Suresh Babu, Haritha Duvvuru, Jillian Baker, Stephanie Switalski, Mehdi Shafa, Krishna Morgan Panchalingam, Saedeh Dadgar, Justin Beller, Behnam Ahmadian Baghbaderani

{"title":"Characterization of human induced pluripotent stems cells: Current approaches, challenges, and future solutions","authors":"Sahana Suresh Babu, Haritha Duvvuru, Jillian Baker, Stephanie Switalski, Mehdi Shafa, Krishna Morgan Panchalingam, Saedeh Dadgar, Justin Beller, Behnam Ahmadian Baghbaderani","doi":"10.1016/j.btre.2023.e00784","DOIUrl":"10.1016/j.btre.2023.e00784","url":null,"abstract":"<div>Human induced pluripotent stem cells (iPSC) have demonstrated massive potentials for use in regenerative and personalized medicine due to their ability to expand in culture and differentiate into specialized cells with therapeutic benefits. However, in order to industrialize iPSC-derived therapies, it is necessary to address the existing challenges surrounding the analytics implemented in the manufacturing process to evaluate and monitor cell expansion, differentiation, and quality of the final products. Here, we review some of the key analytical methods used as part of identity, potency, or safety for in-process or final product release testing and highlighted the challenges and potential solutions for consideration in the Chemistry, Manufacturing and Controls (CMC) strategy for iPSC-based therapies.Some of the challenges associated with characterization and testing of iPSC-based products are related to the choice of analytical technology (to ensure fit-for-purpose), assay reliability and robustness. Automation of analytical methods may be required to reduce hands on time, and improve reliability of the methods through reducing assay variability. Indeed, we have shown that automation of analytical methods is feasible (evaluated using an ELISA based assay) and would result in more precise measurements (demonstrated by lower co-efficient of Variation and standard deviation), less hands-on time, and swift compared to a manually run assay. Therefore, in order to support commercialization of iPSC-based therapies we suggest a well-designed testing strategy to be established in the development phase while incorporating robust, reproducible, reliable, and potentially automated analytics in the manufacturing process.</div>","PeriodicalId":38117,"journal":{"name":"Biotechnology Reports","volume":"37 ","pages":"Article e00784"},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/aa/c0/main.PMC9929203.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10767425","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: 2