Parvin Safaiefar, Somayeh Reiisi, Mehdi Haghi, Sadegh Shirian
{"title":"A PVA/chitosan/gelatin scaffold incorporating salicylic acid-loaded TiO₂ nanoparticles enhances collagen I expression and accelerates cutaneous wound repair in mice","authors":"Parvin Safaiefar, Somayeh Reiisi, Mehdi Haghi, Sadegh Shirian","doi":"10.1002/btpr.88500","DOIUrl":"10.1002/btpr.88500","url":null,"abstract":"<p>Wound healing is a complex biological process requiring coordinated cellular and molecular responses, motivating the development of bioactive scaffolds capable of modulating the wound microenvironment. In this study, a nanocomposite scaffold composed of chitosan, polyvinyl alcohol (PVA), and gelatin incorporating salicylic acid-loaded titanium dioxide nanoparticles (TiO₂ NPs) was fabricated and evaluated for wound-healing applications. TiO₂ nanoparticles synthesized via a co-precipitation method exhibited nanoscale dimensions, high crystallinity, a negative surface charge (−19.4 mV), and a drug-loading efficiency exceeding 90%. The scaffold showed good structural integrity under physiological conditions, excellent hemocompatibility (<5% hemolysis), and a swelling ratio of approximately 50%. Sustained, pH-independent release of salicylic acid was observed. In vitro studies demonstrated that the nanocomposite increased fibroblast migration by approximately 90% compared with untreated controls and significantly upregulated COL1 gene expression by 2.5-fold (<i>p</i> < 0.05), while maintaining high cell viability. In a murine excisional wound model, the nanocomposite-treated group achieved 85% wound closure by day 10, compared with 30% in untreated wounds and 50% in the drug-free scaffold group (<i>p</i> < 0.05), along with improved epidermal regeneration. Overall, these results indicate that controlled delivery of salicylic acid from a TiO₂-containing polymeric scaffold supports fibroblast activity, collagen-related responses, and wound closure, providing a rational basis for further optimization of multifunctional wound dressings.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 4","pages":""},"PeriodicalIF":2.8,"publicationDate":"2026-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147832996","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}
Jaka Kranjc, Stane Pajk, Marko Anderluh, Anja Pišlar, Matjaž Brinc
{"title":"β-1,4-galactosyltransferase 1 inhibitors modulate cellular N-glycan profiles","authors":"Jaka Kranjc, Stane Pajk, Marko Anderluh, Anja Pišlar, Matjaž Brinc","doi":"10.1002/btpr.88522","DOIUrl":"10.1002/btpr.88522","url":null,"abstract":"<p>N-glycosylation is a key post-translational modification of proteins influencing their physicochemical properties as well as biological activity. This study investigates the <i>in vivo</i> activity of four β-1,4-galactosyltransferase 1 inhibitors in cell cultures producing recombinant IgG antibodies. Inhibitors, previously identified as potent inhibitors in on-target assay, were evaluated in fed-batch bioprocesses. Dose-dependent effects on cell culture performance were assessed following compound addition. N-glycan profiles were analyzed using InstantPC labeling and UHPLC-FLD, while intracellular compound concentrations were quantified via LC–MS/MS following time-resolved sampling of treated cell lysates. Bioprocess parameters, including cell growth, viability, and productivity, were monitored throughout cultivation. The study revealed divergent behaviors between on-target potency and <i>in vivo</i> activity, underscoring the importance of cellular permeability, metabolic stability, and off-target effects of potential inhibitors used in cell culture. These findings provide new insights into the challenges of glycosylation pathway modulation and inform strategies for future glycoengineering tool development.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 4","pages":""},"PeriodicalIF":2.8,"publicationDate":"2026-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13441389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147980323","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}
Bowen J. Houser, Camille A. Bryner, Aaron D. Rappleyea, Breckin L. Forstrom, Alyson N. Camacho, Justin B. Wood, Roger G. Harrison, Karine Chesnel, William G. Pitt
{"title":"Binding of bacteria to magnetic nanoparticles in suspension: Experiments and kinetic models","authors":"Bowen J. Houser, Camille A. Bryner, Aaron D. Rappleyea, Breckin L. Forstrom, Alyson N. Camacho, Justin B. Wood, Roger G. Harrison, Karine Chesnel, William G. Pitt","doi":"10.1002/btpr.88518","DOIUrl":"10.1002/btpr.88518","url":null,"abstract":"<p>With the rise of antimicrobial-resistant and multi-drug-resistant bacteria, the use of magnetic nanoparticles (MNPs) has become a promising tool for separation processes in conjunction with in vitro diagnostics for the rapid identification of bacterial species in various medical and biological fluids. However, there are few studies on the time required for MNPs to successfully capture and remove bacteria from suspensions. This study presents two mathematical models that describe the kinetics of bacterial capture using polydopamine-coated MNPs (pDA-MNPs) in phosphate-buffered saline. The model parameters are derived from data from the capture of <i>Staphylococcus aureus</i>, <i>Staphylococcus epidermidis</i>, and <i>Streptococcus mutans</i>, which exhibit high adherence to pDA-MNPs. Results show that during the first 3 min, bacterial capture and removal by magnetic particles show second-order kinetics overall, and first order each with respect to bacterial concentration and to magnetic particle concentration. At longer times, the data are better fit by a model of fast and slow parallel capture mechanisms. pDA-MNPs capture <i>S. epidermidis</i> faster than <i>S. aureus</i>, and capture <i>S. mutans</i> more slowly than the other bacterial species. Rate constants derived at very high bacterial concentrations (~10<sup>8</sup> CFU/mL) were also found to fit experimental data collected at very low concentrations (~750 CFU/mL), showing applicability of the model spanning several orders of magnitude in bacterial concentration. Analysis of the kinetic parameters provides insights into optimizing the time and MNP concentrations necessary to achieve a desired bacterial capture efficiency in medical or environmental diagnostic applications.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":"42 4","pages":""},"PeriodicalIF":2.8,"publicationDate":"2026-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148004365","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}
{"title":"Infrared spectroscopy-based chemometric modeling for monitoring mesenchymal stem cell functional decline across donors.","authors":"Saravana Kumar Ganesan, Gargi Ghosh","doi":"10.1002/btpr.88548","DOIUrl":"https://doi.org/10.1002/btpr.88548","url":null,"abstract":"<p><p>Reliable assessment of cellular state remains a challenge in cell therapy manufacturing and regenerative medicine. Proliferative capacity, senescence, and metabolic activity are traditionally measured using labor-intensive assays, limiting timely and integrated assessment of cellular state. Here, we apply attenuated total reflection-Fourier transform infrared spectroscopy coupled with multivariate analysis to assess whether intrinsic vibrational fingerprints of mesenchymal stem cells reflect coordinated functional changes during in vitro expansion. By integrating proliferation kinetics, metabolite fluxes, and senescence-associated phenotype into a composite functional score, we mapped progressive functional decline across passages onto infrared spectral changes. Spectral alterations were associated with shifts in lipid-related and protein-associated regions as senescence accumulated. Despite strong donor-specific differences, we identified conserved spectral fingerprint regions that tracked functional decline across donor samples analyzed. These shared biochemical signatures were associated with the prediction of senescence progression and the estimation of functional passage in an independent donor sample. Together, our results show that intrinsic vibrational fingerprints capture coordinated biochemical changes during cellular decline and provide a label-free, rapid means to assess cellular state.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e88548"},"PeriodicalIF":2.8,"publicationDate":"2026-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148663457","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}
Guillaume Cogne, Claude-Gilles Dussap, Jack Legrand
{"title":"A biochemically structured predictive model of eukaryotic microalgal growth: Integrating radiative transfer, respiration, and pigment acclimation.","authors":"Guillaume Cogne, Claude-Gilles Dussap, Jack Legrand","doi":"10.1002/btpr.88543","DOIUrl":"https://doi.org/10.1002/btpr.88543","url":null,"abstract":"<p><p>Predictive modeling of phototrophic cultures in photobioreactors remains challenging because growth emerges from the coupling between radiative transfer, intracellular bioenergetics, and physiological acclimation. Although existing approaches have progressively integrated light attenuation and reactor-scale heterogeneity, extending knowledge-based formulations to eukaryotic microalgae still raises difficulties, especially regarding the role of respiration under illumination and the dynamic adjustment of pigment content. In this work, we establish a biochemically structured predictive model of photoautotrophic growth for the eukaryotic microalga Chlamydomonas reinhardtii. The model is built from an explicit stoichiometric decomposition of the main metabolic functions involved in biomass synthesis, pigment synthesis, photosynthetic energy conversion, respiration, and ATP-consuming futile processes under redox regulation. Its structure is derived from intracellular conservation relationships and observability analysis, leading to a reduced formulation driven by two variables: the net conversion rate of photochemically productive photons within the biotic phase, <math> <mrow><msub><mi>q</mi> <mi>γ</mi></msub> </mrow> </math> , and a dissipative ATP sink. The kinetic formulation explicitly couples growth to radiative transfer and accounts for dynamic pigment acclimation through variable partitioning of biomass formation between residual biomass and pigments. Model parameters were either fixed from previous physiological and bioenergetic analyses or identified from batch-culture experiments performed under different incident photon flux densities in a flat-panel photobioreactor illuminated from one side. The model satisfactorily predicts biomass and pigment dynamics in batch and continuous cultures over a broad range of light conditions and dilution rates, while comparisons with oxygen-exchange measurements under illumination provide additional support for its structural relevance. The proposed framework provides a predictive and mechanistically interpretable description of eukaryotic microalgal growth in photobioreactors.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e88543"},"PeriodicalIF":2.8,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148583485","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}
Kevin Vera, Ivan Gajic, Praveen Kusumanchi, Angela Andaluz, Gabrielle Dela Pena, Clifford A Froelich, Elizabeth Higgins, Jennifer Johnston, Seyed Pouria Motevalian
{"title":"High-throughput development and scale-up of recombinant adeno-associated virus 5 anion-exchange chromatography for high-purity capsid separation.","authors":"Kevin Vera, Ivan Gajic, Praveen Kusumanchi, Angela Andaluz, Gabrielle Dela Pena, Clifford A Froelich, Elizabeth Higgins, Jennifer Johnston, Seyed Pouria Motevalian","doi":"10.1002/btpr.88542","DOIUrl":"https://doi.org/10.1002/btpr.88542","url":null,"abstract":"<p><p>Recombinant adeno-associated virus (rAAV) production commonly yields a high proportion of empty and partially filled capsids, necessitating downstream purification to enrich full capsids. Among purification approaches, anion-exchange chromatography (AEX) has emerged as a scalable alternative to ultracentrifugation. In this study, a structured and scalable development strategy for AAV5 AEX purification is presented. A high-throughput, ultra-scale-down platform using 200 μL RoboColumns™ was established to enable rapid screening of salt systems, additives, and operating conditions with minimal material requirements. Dual-salt systems were evaluated to decouple ionic strength from ion-specific effects, leading to the identification of a magnesium-only system (MgCl<sub>2</sub>/MgSO<sub>4</sub>) that improved both enrichment and recovery. Optimized conditions achieved >85% full capsids with robust recovery and >90% full capsids in peak fractions. Scalability was demonstrated through strong agreement between ultra scale-down (200 μL) and scale-down (1 mL) formats. A QbD-aligned framework was applied to define the purity-recovery design space and guide selection of operating conditions based on target product profile. The optimized gradient process was translated into a manufacturing-relevant isocratic step format, with systematic evaluation of buffer conductivity sensitivity and load robustness to address large-scale operational constraints.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e88542"},"PeriodicalIF":2.8,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148560758","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}
{"title":"Screening of bispecific antibodies during single cell cloning of recombinant Chinese hamster ovary cell lines to improve titer and product quality.","authors":"Molly Robinson, Jessica Willmott, Holly Corrigall, Daniela Lega, Joseph Stirling, Vithiya Vimalraj, Mitul Patel, Robyn Emmins","doi":"10.1002/btpr.88539","DOIUrl":"https://doi.org/10.1002/btpr.88539","url":null,"abstract":"<p><p>Development of therapeutic bispecific antibodies (BsAbs) poses significant manufacturability challenges associated with correct chain pairing and an increased diversity of impurities. Here we address this with a product quality assessment during cell line development (CLD), forgoing the need for genetic characterization during cell line screening. Using Chinese Hamster Ovary (CHO) cell lines expressing a panel of monoclonal antibodies (mAb) and BsAbs, we demonstrate the highly specific binding of SpotLight™ Huλ, Huĸ and HuFc reagents to their target chain isotypes (lambda or kappa light chain and Fc regions) during single cell cloning workflows on a Bruker Beacon® Optofluidic System. We then demonstrate combinatorial use of SpotLight™ Huλ and Huĸ reagents as an early product quality indicator on a CHO cell line expressing a BsAb with dual kappa-lambda light chain configuration. Cell lines presenting equal binding profiles for each SpotLight assay exhibited platform-typical heterodimer levels with an average of 87.26% following fed-batch bioreactor production assessment. Conversely, cell lines biased towards either SpotLight™ assay resulted in lower than desired heterodimer (0%-84.23%) and increased associated impurities. This study demonstrates the application of dual SpotLight™ assays as an identifier of CHO cell lines expressing a kappa-lambda light chain BsAb with a high heterodimer percentage. This allows cell lines with optimal product quality to be identified earlier in CLD, resulting in fewer cell lines being progressed to resource-intensive fed-batch studies and subsequent product quality assessment. Furthermore, this assay provides an opportunity to characterize impurity expression biases prior to developing downstream purification processes.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e88539"},"PeriodicalIF":2.8,"publicationDate":"2026-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148454586","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}
Rebekka Horstmann, Mario Beckers, Jörn Viell, Fabian Allan Watt, Valentin Steier, Marcel Mann, Jørgen B Magnus
{"title":"Scalable catalyst production process for oleate hydratase whole-cell biocatalysis.","authors":"Rebekka Horstmann, Mario Beckers, Jörn Viell, Fabian Allan Watt, Valentin Steier, Marcel Mann, Jørgen B Magnus","doi":"10.1002/btpr.88535","DOIUrl":"https://doi.org/10.1002/btpr.88535","url":null,"abstract":"<p><p>The sustainable production of hydroxy fatty acids, such as 10-hydroxystearic acid (10-HSA), by biocatalysis is a promising alternative to petrochemical and castor oil-derived products. However, industrial implementation still requires an efficient and scalable process for biocatalyst production by fermentation, which precedes the biotransformation to 10-HSA. In general, industrial biocatalysis is commonly performed using whole cells, which are cheaper than purified enzymes. Still, the fermentation process itself is a major cost contributor requiring a high-yielding and scalable process. Here, we established and scaled a lactose-induced fed-batch process to produce an Escherichia coli BL21 (DE3) based whole-cell biocatalyst containing an oleate hydratase from Stenotrophomonas nitritireducens. The two-phased process employs an initial growth phase on glucose, followed by an induced feed phase using glycerol and lactose. When comparing two different growth rates during enzyme expression, a higher growth rate was found beneficial, resulting in a higher biomass concentration of 69.2 ± 0.5 g L<sup>-1</sup> and a yield increase of 80 % while maintaining biocatalyst activity at >85 % conversion. This highlights the importance of process design variables, such as growth rate settings, for a high-yielding and economic process. Feasibility of the process was demonstrated by scaling into a 150 L bioreactor, achieving a biomass concentration of 60.6 ± 0.4 g L<sup>-1</sup> with a yield of 0.44 g<sub>C,Biomass</sub> g<sub>C</sub> <sup>-1</sup> and 91.5 ± 1.4 % conversion. Supplemented with an initial test of suitable unit operations for technical biomass separation, this work provides a fermentation route for a whole-cell oleate hydratase biocatalyst, paving the way for further scaling toward industrial 10-HSA production.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e88535"},"PeriodicalIF":2.8,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148444129","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}
{"title":"A 3D-printed multi-well lung-on-chip platform with bioprinted stromal compartment for upper airway tissue culture and antiviral drug evaluation.","authors":"Pooja Sawant, Gudepalya Renukaiah Rudramurthy, Varun Kailaje, Radha Krishan Shandil, Shridhar Narayanan, Ratnesh Jain, Prajakta Dandekar","doi":"10.1002/btpr.88538","DOIUrl":"https://doi.org/10.1002/btpr.88538","url":null,"abstract":"<p><p>Physiologically relevant lung-on-chip (LoC) systems remain constrained by polydimethylsiloxane (PDMS) limitations including small-molecule adsorption and mechanical deformation of device microchannels under perfusion, single-channel architectures limiting parallel tissue culture, and absence of organized stromal and immune compartments. Existing platforms predominantly model the distal airway, leaving the upper airway, the primary site of respiratory viral entry, insufficiently addressed as an in vitro tissue model for preclinical drug evaluation. We report a six-well, 3D-printed LoC platform fabricated using a photopolymer resin that addresses these limitations. Computational fluid dynamics (CFD)-guided design ensured uniform perfusion across all six wells, enabling parallel tissue culture within a single device. The photopolymer architecture eliminated mechanical deformation of the device microchannels under prolonged perfusion and demonstrated significantly reduced small-molecule adsorption relative to PDMS, improving quantitative reliability for drug evaluation workflows. Human tracheobronchial epithelial cells differentiated at air-liquid interface expressed MUC5AC and cytokeratin-14, formed continuous ZO-1 tight junctions, and achieved a transepithelial electrical resistance of ~800 Ω·cm<sup>2</sup>, consistent with physiological barrier integrity. A GelMA-based stromal compartment, fabricated by extrusion bioprinting of lung fibroblast- and THP-1 monocyte-laden bioink, established a layered epithelial-stromal-immune architecture. Functional validation demonstrated IL-6 and IL-8 elevation following SARS-CoV-2 spike S1 stimulation, IFN-γ-driven modulation of apical ACE2 expression, and coordinated TNF-α, IL-6, and IL-8 release during Influenza A infection, all suppressed by oseltamivir treatment. This platform integrates CFD-optimized multi-well device fabrication, extrusion bioprinting of stromal constructs, and photopolymer resin-based microfluidic manufacturing into a reproducible, human-relevant upper airway model for respiratory infection research and preclinical antiviral drug evaluation.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e88538"},"PeriodicalIF":2.8,"publicationDate":"2026-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148435096","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}
{"title":"Demonstration of nanofiltration-based virus safety for AAV manufacturing using model viruses.","authors":"Brian Buesing, Tomoki Igi, Daniel Strauss","doi":"10.1002/btpr.88541","DOIUrl":"https://doi.org/10.1002/btpr.88541","url":null,"abstract":"<p><p>Virus safety for biopharmaceutical products has been a well-established concern for several decades. While various virus reduction steps have been identified and implemented for traditional plasma-derived and monoclonal antibody products, there are various challenges to achieving the same virus safety in emerging gene therapy products. Virus removal filtration, or nanofiltration, has proven difficult to implement for larger gene therapy modalities, though there is a regulatory expectation to incorporate this step for smaller modalities such as adeno-associated virus (AAV) vector products. Here, we demonstrate the applicability of a virus removal filter with a 35 nm mean pore size distribution for AAV processes based on filtrations with porcine parvovirus (PPV) as a model for AAV vector and simian virus 40 (SV40) as a model contaminant virus. Filtration runs were performed at low pressure and included a defined process pause, two manufacturing conditions known to potentially impact viral clearance. All filtrations demonstrated SV40 reduction to below the limit of detection and no detectable reduction in PPV, indicating robust removal of large contaminating viruses without impacting product yields for AAV products. Thus, virus removal filtration is appropriate for the removal of adventitious viruses in gene therapy product manufacturing. Virus removal filters have an established history of improving patient safety and should be included in the manufacture of advanced gene therapy products whenever possible.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e88541"},"PeriodicalIF":2.8,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148403405","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}