Biotechnology Progress最新文献_第10页

Functional CRISPR-Cas9 knockout screening of the genetic determinants of human fibroblast migration propensity 功能性CRISPR-Cas9基因敲除筛选人成纤维细胞迁移倾向的遗传决定因素。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-10-02 DOI: 10.1002/btpr.70076

Antonio Mazzei, Sebastian Martewicz, Ramin Amiri, Meihua Cui, Nicola Elvassore, Camilla Luni

{"title":"Functional CRISPR-Cas9 knockout screening of the genetic determinants of human fibroblast migration propensity","authors":"Antonio Mazzei, Sebastian Martewicz, Ramin Amiri, Meihua Cui, Nicola Elvassore, Camilla Luni","doi":"10.1002/btpr.70076","DOIUrl":"10.1002/btpr.70076","url":null,"abstract":"Directional cell migration plays a central role in a wide range of physiological and pathological conditions, such as embryonic development or tumor metastasis. Steps involved in cell migration include cell polarization, formation of membrane protrusions at the cell front side and adhesion disassembly at the rear side, and a general cytoskeletal rearrangement. Overall, it is a complex phenomenon at the interface between mechanical forces and biochemical signaling, with cell-specific and context-specific molecular events acting in the process. Here, we focus on human fibroblast migration induced by a biochemical gradient with an approach that connects the identification of molecular players with the actual mechanical function. We show how to screen for genes and miRNAs involved in migration by the direct integration of a high-throughput gene editing method, the CRISPR-Cas9 knockout pool screening, and a well-established functional assay, the transwell migration assay. Moreover, the screening has been performed after an expansion step aiming at the removal of all the essential genes and miRNAs, so as to identify targets related to the cell migratory ability without affecting other major cellular functions. The results confirm known genes involved in migration, but also highlight new candidates. This work establishes a methodological advancement in the use of CRISPR technology for functional screening and represents a resource for candidate genes and miRNAs playing a role in human fibroblast directional migration under biochemical gradient.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12908101/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Identification of the differential and synergic lipotoxic patterns of oleic acid, palmitic acid, and their mixture in 3D HepG2/C3A tissue using liver-on-chip technology 利用肝脏芯片技术鉴定油酸、棕榈酸及其混合物在三维HepG2/C3A组织中的差异和协同脂毒模式。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-10-13 DOI: 10.1002/btpr.70075

Lisa Morisseau, Valérie Pawlowski, Valérie Plaisance, Mathilde Lucas, Cécile Legallais, Yasuyuki Sakai, Amar Abderrahmani, Rachid Jellali, Eric Leclerc

{"title":"Identification of the differential and synergic lipotoxic patterns of oleic acid, palmitic acid, and their mixture in 3D HepG2/C3A tissue using liver-on-chip technology","authors":"Lisa Morisseau, Valérie Pawlowski, Valérie Plaisance, Mathilde Lucas, Cécile Legallais, Yasuyuki Sakai, Amar Abderrahmani, Rachid Jellali, Eric Leclerc","doi":"10.1002/btpr.70075","DOIUrl":"10.1002/btpr.70075","url":null,"abstract":"The metabolic dysfunction-associated steatotic liver disease (MASLD, previously formerly known as non-alcoholic fatty liver disease, NAFLD) is rapidly expanding worldwide in parrallel with the obesity pandemic. Dietary fatty acids including oleic (OA) and palmitic acids (PA) contribute to the hepatic intracellular triglyceride accumulation, and are therefore thought to play key roles in disease development and progression. Taking advantage of the cutting-edge organ-on-chip technology that mimics the 3D organ dynamic environment, we aimed at investigating the role of OA, PA and a 2:1 OA/PA mixture on the growth and function of the HepG2/C3A, a liver cell line model, over 2 and 7 days. OA supported sustained cell growth, leading to dense 3D tissues, whereas PA and OA exposure did not affect cell proliferation. PA treatment downregulated the GLUT2, INSRA, SREBP1, FASN, mRNA levels indicating a lipid metabolism perturbation in our model. The cell dysfunction caused by OA, PA, and OA/PA was associated with an increase in reactive oxygen species (ROS) production over time. Intracellular lipid monitored by oil red O was higher in cells exposed to OA than in the control ones and cells cultured with PA. Our data confirm the role of fatty acids on the growth and dysfunction of HepG2/C3A cells, and highlight distinct mechanisms through which OA and PA exert their effects.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145278975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Enzymatic properties of a bacterial microcystinase A produced in Saccharomyces cerevisiae 酿酒酵母中产生的细菌微胱氨酸酶a的酶学特性。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-10-16 DOI: 10.1002/btpr.70083

Fernando de Godoi Silva, Ralf Greiner, Daiane Dias Lopes, Ronald E. Hector, Elisabete Hiromi Hashimoto, Elisa Yoko Hirooka

{"title":"Enzymatic properties of a bacterial microcystinase A produced in Saccharomyces cerevisiae","authors":"Fernando de Godoi Silva, Ralf Greiner, Daiane Dias Lopes, Ronald E. Hector, Elisabete Hiromi Hashimoto, Elisa Yoko Hirooka","doi":"10.1002/btpr.70083","DOIUrl":"10.1002/btpr.70083","url":null,"abstract":"Microcystins (MCs) are toxins produced by cyanobacteria, posing a significant emerging threat to human and public health. Therefore, control strategies combining frequent toxin monitoring with removal techniques are urgently needed. In this context, microcystin degradation using the bacterial enzyme microcystinase A, originally derived from Sphingosinicella microcystinivorans B9, has been identified as a sustainable and effective approach. To facilitate access to the enzyme, the gene encoding microcystinase A was successfully expressed in the Saccharomyces cerevisiae PE-2 strain. The recombinant microcystinase A was produced as an intracellular enzyme and applied in MC degradation assays. Optimal conditions for enzymatic activity were identified at 42.2°C and pH 6.3. The maximum degradation rate of microcystin was determined to be 3.09 mg/L/h, and a Km of 2.81 μM was obtained when assays were performed at 37°C and pH 7.4. The recombinant microcystinase A remained fully active for 2 h at 20°C. Exposure to 50°C for 1 h resulted in 60% residual activity, while 30 min at 65°C led to complete inactivation. The enzyme was also denatured when exposed to alkaline pH conditions. Therefore, this study provides key data on recombinant microcystinase A, supporting further investigations into its potential applications for MC degradation, particularly under mildly acidic conditions and temperatures up to 45°C.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Kinetic and equilibrium analysis of electrochemical Aptasensing for real-time detection of Staphylococcus aureus in food substances 电化学感应实时检测食品中金黄色葡萄球菌的动力学及平衡分析。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-10-27 DOI: 10.1002/btpr.70088

Shokoufeh Soleimani, Tracy Ann Bruce-Tagoe, Michael K. Danquah

{"title":"Kinetic and equilibrium analysis of electrochemical Aptasensing for real-time detection of Staphylococcus aureus in food substances","authors":"Shokoufeh Soleimani, Tracy Ann Bruce-Tagoe, Michael K. Danquah","doi":"10.1002/btpr.70088","DOIUrl":"10.1002/btpr.70088","url":null,"abstract":"Real-time detection of foodborne pathogens such as Staphylococcus aureus (S. aureus) is essential for ensuring food safety. In this study, we evaluate the performance of an electrochemical aptasensor developed from gold nanoparticles (AuNPs)-immobilized screen-printed carbon electrode for the detection of low concentrations of S. aureus in chicken extract media. Using cyclic voltammetry (CV), the dynamic interaction between the aptamer-modified electrode and S. aureus was monitored across four bacterial concentrations of 1, 5, 10, and 20 colony-forming units per milliliter (CFU/mL) at 35-min intervals over 350 min. The aptasensor demonstrated a concentration-dependent response with increasingly lower maximum CV signals and faster time to equilibrium as CFU increased. Real-time kinetic and equilibrium parameters were extracted to understand the binding behavior of the pathogen to the electrode surface. Critical parameters such as the kinetic rate constant (k) of 0.0274 min−1 and equilibrium dissociation constants (<math>\u0000 <mrow>\u0000 <msub>\u0000 <mi>K</mi>\u0000 <mi>d</mi>\u0000 </msub>\u0000 </mrow></math>) of 7.35 CFU/mL, were derived from the CV signals. Langmuir isotherm modeling yielded a maximum binding capacity (<math>\u0000 <mrow>\u0000 <msub>\u0000 <mi>B</mi>\u0000 <mi>max</mi>\u0000 </msub>\u0000 </mrow></math>) of 33.55 μA. In addition, a Hill coefficient (nH) of 0.65 was obtained, which indicates a slightly negative cooperativity. These findings demonstrate the capability of the aptasensor for real-time detection of S. aureus, offering a robust framework for field-deployable pathogen monitoring in food matrices.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145375420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Optimizing sterile filtration of nanoemulsions through proper choice of prefilter properties 通过选择合适的预过滤性能，优化纳米乳的无菌过滤。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-10-31 DOI: 10.1002/btpr.70087

Shreya Kapila, Randal J. Soukup, Marissa E. Bradley, David Boyd, Andrew L. Zydney

{"title":"Optimizing sterile filtration of nanoemulsions through proper choice of prefilter properties","authors":"Shreya Kapila, Randal J. Soukup, Marissa E. Bradley, David Boyd, Andrew L. Zydney","doi":"10.1002/btpr.70087","DOIUrl":"10.1002/btpr.70087","url":null,"abstract":"Nanoemulsions, with droplet sizes between 20 and 200 nm, have emerged as a promising vaccine adjuvant and drug delivery system, enhancing the solubility of hydrophobic drugs for diverse applications. Sterile filtration of nanoemulsions is particularly challenging due to the similar size between the nanodroplets and the 0.2 μm nominal pore size rating of sterile filters. One approach to reducing membrane fouling, and enhancing filtration capacity and yield, is to employ an appropriate prefilter, but there are currently no clear guidelines on how to select the prefilter pore size, chemistry, or morphology for sterile filtration of nanoemulsions. This study examined the performance of a range of prefilters with varying pore morphologies and surface chemistries. Sessile drop contact angles were used to evaluate the prefilter hydrophobicity, and bubble point and mercury intrusion porosimetry were used to evaluate the pore characteristics of the different prefilters. The best performance was achieved using a relatively hydrophobic 0.45 μm prefilter made of polyvinylidene fluoride but modified with a somewhat hydrophilic (oxygen-containing) coating. This prefilter reduced the surface tension of the nanoemulsion and provided more than a 2-fold increase in capacity for a variety of sterile filters. These results provide critical insights into the factors influencing nanoemulsion filtration and offer a framework for selection of appropriate prefilters in biopharmaceutical manufacturing.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12908093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145407819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Scalable production and biophysical characterization of an enzyme cocktail derived from human red blood cells 从人红细胞中提取的鸡尾酒酶的规模化生产和生物物理特性。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-09-19 DOI: 10.1002/btpr.70072

Mohd Asim Khan, Griffin J. Beyer, Naomi Goosby, Lilly Ortiz, Andre F. Palmer

{"title":"Scalable production and biophysical characterization of an enzyme cocktail derived from human red blood cells","authors":"Mohd Asim Khan, Griffin J. Beyer, Naomi Goosby, Lilly Ortiz, Andre F. Palmer","doi":"10.1002/btpr.70072","DOIUrl":"10.1002/btpr.70072","url":null,"abstract":"Red blood cells (RBCs) play a critical role in oxygen and carbon dioxide transport, which is facilitated by RBC-encapsulated hemoglobin (Hb) and carbonic anhydrase (CA). In addition, RBCs are constantly exposed to oxidative stress due to the intracellular reactive oxygen species (ROS) generated during Hb auto-oxidation. Antioxidant enzymes within RBCs, such as superoxide dismutase (SOD), catalase (CAT), and peroxiredoxin (Prx), counteract ROS generation to protect the RBC from oxidative stress. Therefore, this study presents a scaled-up method to extract an enzyme cocktail from lysed human RBCs, enriched with the major RBC enzymes with minimal Hb contamination. Using ethanol-chloroform precipitation and multiple biophysical analyses (SDS-PAGE, SEC-HPLC, MALDI-TOF, and LC-MS/MS), the RBC enzymes were successfully separated from Hb in the hemolysate. The purified enzyme cocktail exhibited minimal Hb contamination and retained a significant amount of CA, and antioxidative enzymes like SOD and CAT. Therefore, this scalable RBC enzyme purification method provides an efficient approach for isolating RBC enzymes with broad biomedical relevance.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12908105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Secondary feed filtration and storage conditions influence trace element availability and process performance at 2000 L scale 二次进料过滤和贮存条件影响2000l规模下微量元素的利用率和工艺性能。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-09-25 DOI: 10.1002/btpr.70071

Abhinav R. Jain, Juan Sebastian Reyes, Cuijuan Yuan, Qing Zhao, Ruiqiang Sun, Hang Zhou, Vikram Sisodiya, Yashas Rajendra

{"title":"Secondary feed filtration and storage conditions influence trace element availability and process performance at 2000 L scale","authors":"Abhinav R. Jain, Juan Sebastian Reyes, Cuijuan Yuan, Qing Zhao, Ruiqiang Sun, Hang Zhou, Vikram Sisodiya, Yashas Rajendra","doi":"10.1002/btpr.70071","DOIUrl":"10.1002/btpr.70071","url":null,"abstract":"Achieving consistent CHO cell culture performance during process scale-up is critical but often challenged by subtle changes in operational parameters. This study investigates how differences in feed media filtration and storage during scale-up can impact CHO cell culture performance. A 70% reduction in titer and a 25% drop in peak viable cell density (VCD) were observed at 2000 L scale. Root cause analysis revealed that the secondary filtration of feed media was likely a contributing factor. Trace element analysis confirmed significant copper(II) ions (Cu2+) loss in feed media at 2000 L, likely due to precipitation during storage and subsequent removal by secondary sterile filtration. This resulted in continued lactate accumulation and reduced titer. Feed storage conditions had an impact on Cu2+ stability, with room temperature storage accelerating Cu2+ loss when compared to storage at 2 to 8°C. By eliminating the secondary filtration step and optimizing feed media storage conditions, process performance was successfully restored at 2000 L scale, matching smaller scale performance. This study highlights how feed filtration and storage critically affect micronutrient stability and availability during scale-up. While secondary filtration may be used for additional microbial control, it can inadvertently alter feed composition, affecting cell metabolism and productivity. Thorough evaluation of feed stability, filtration, and storage strategies is therefore key to ensuring consistent bioreactor performance across scales.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An economically cost-effective production medium optimization of Bacillus subtilis Ö-4-68: A potential probiotic for aquaculture 经济高效的枯草芽孢杆菌生产培养基优化Ö-4-68：一种潜在的水产养殖益生菌。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-09-24 DOI: 10.1002/btpr.70070

Sezen Demirhan-Yazıcı, Kemal Karaca, Ayşe Nalbantsoy, Rengin Eltem

{"title":"An economically cost-effective production medium optimization of Bacillus subtilis Ö-4-68: A potential probiotic for aquaculture","authors":"Sezen Demirhan-Yazıcı, Kemal Karaca, Ayşe Nalbantsoy, Rengin Eltem","doi":"10.1002/btpr.70070","DOIUrl":"10.1002/btpr.70070","url":null,"abstract":"Probiotic use has become more important in aquaculture for healthy and sustainable output. In particular, Bacillus spp. have emerged as effective probiotic agents, improving gut health, enhancing the immune system, promoting growth, and providing protection against pathogens in fish. Therefore, the application of Bacillus in aquaculture offers a strategic approach to increasing productivity while reducing the reliance on antibiotics. In this study, the antibacterial activities of Bacillus isolates, whose probiotic properties will be determined, against test bacteria that are fish pathogens such as Aeromonas hydrophila, Vibrio anguillarum, Lactococcus garvieae, and Yersinia ruckeri were determined by using cross-streak method and agar well diffusion methods. Then, antibiotic resistances of 75 isolates determined to have antibacterial activity were screened against 9 different antibiotics by the agar disc diffusion method. Gastric juice (pH 2.5) tolerance of 55 isolates determined to be sensitive to antibiotics was examined, and the tolerance of 13 isolates to gastric juice was determined. Optimum growth characteristics at acidic pH, surface hydrophobicity, bile tolerance, and protease, amylase, lipase, and cellulase activities, hemolytic activities, coagulase activities, bacterial adhesion abilities, and biofilm production properties of these isolates were determined. As a result, Bacillus subtilis Ö-4-68, with the best probiotic properties, was selected from the examined isolates, and production medium optimization was carried out with laboratory scale statistical experiment design (Response Surface Methodology, RSM) for high amount of biomass production. As a result of the trials, an economical cost-effective production medium content with high biomass production was determined.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145129977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Optimizing monoclonal antibody biosimilar production via transfer and active learning for targeted quality profiles 通过转移和主动学习优化单克隆抗体生物仿制药的生产。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-10-23 DOI: 10.1002/btpr.70086

Jashwant Kumar, Reema Sultana, Deeksha Saripalla, Viki Chopda, Velu Mahalingam, Laxmi Adhikary

{"title":"Optimizing monoclonal antibody biosimilar production via transfer and active learning for targeted quality profiles","authors":"Jashwant Kumar, Reema Sultana, Deeksha Saripalla, Viki Chopda, Velu Mahalingam, Laxmi Adhikary","doi":"10.1002/btpr.70086","DOIUrl":"10.1002/btpr.70086","url":null,"abstract":"Biosimilar development of monoclonal antibodies (mAbs) is gaining significant momentum as numerous blockbuster biologics approach their patent expiry in the current decade. A critical challenge in biosimilar development lies in achieving product quality attributes(PQAs) comparable to the innovator product. PQAs in upstream processing are influenced by multiple factors, including cell line selection, media composition, feeding strategy, supplements, and bioreactor process parameters, with physical parameter optimization playing a pivotal role in enhancing both product titer and modulating PQAs. In this study, we systematically evaluated the impact of physical process parameters—pH and temperature along with initial seeding density (ISD)—on N-glycan profiles and charge variants across four biosimilar development projects (Projects 1–4). Stepwise regression models were developed between process parameters and product quality attributes using JMP software to establish parameter-attribute relationships. Our results demonstrated that lowering culture pH reduced %acidic variants and %galactosylation while increasing %basic variants and %afucosylation (AF). Increased culture temperature resulted in an increase in %acidic variants and a decrease in %AF. This parameter-attribute relationships knowledge base was directly applied in experimental design to expedite the development of a fifth mAb biosimilar development (Project 5), substantially reducing experimental iterations and development timelines, exemplifying the practical implementation of Bioprocessing 4.0 principles.","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 1","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Special issue on integrated continuous biomanufacturing 集成连续生物制造特刊。

IF 2.5 3区生物学

Biotechnology Progress Pub Date : 2026-02-16 Epub Date: 2025-05-21 DOI: 10.1002/btpr.70039

Jason Walther

引用次数: 0