@misc{overton_boi_shastry_smith-moore_balchunas_sambandan_gilleskie_2023, title={Development and Delivery of a Hands-On Short Course in Adeno-Associated Virus Manufacturing to Support Growing Workforce Needs in Gene Therapy}, volume={34}, ISSN={["1557-7422"]}, url={http://dx.doi.org/10.1089/hum.2022.235}, DOI={10.1089/hum.2022.235}, abstractNote={The manufacturing of gene therapy products is a rapidly growing industry bolstered by the tremendous potential of these therapies to provide lifesaving treatment for rare and complex genetic diseases. The industry's steep rise has resulted in a high demand for skilled staff required to manufacture gene therapy products of the expected high quality. To address this skill shortage, more opportunities for education and training in all aspects of gene therapy manufacturing are needed. The Biomanufacturing Training and Education Center (BTEC) at the North Carolina State University (NC State) has developed and delivered (and continues to deliver) a four-day, hands-on course titled Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy. The course, which consists of 60% hands-on laboratory activities and 40% lectures, aims to provide a comprehensive understanding of the gene therapy production process, from vial thaw through the final formulation step, and analytical testing. This paper discusses the design of the course, the backgrounds of the nearly 80 students who have participated in the seven offerings held since March 2019, and feedback from the course participants.}, number={7-8}, journal={HUMAN GENE THERAPY}, publisher={Mary Ann Liebert Inc}, author={Overton, Laurie and Boi, Cristiana and Shastry, Shriarjun and Smith-Moore, Caroline and Balchunas, John and Sambandan, Deepa and Gilleskie, Gary}, year={2023}, month={Apr}, pages={259–272} }
 @inbook{stevnsborg_selle_barton_prado-rubio_gargalo_gernaey_gilleskie_huusom_2023, title={Digital Twins in Pilot Scale Fermentation: Non-Linear State Estimation for Improving Induction Timing}, ISBN={9780443152740}, ISSN={1570-7946}, url={http://dx.doi.org/10.1016/B978-0-443-15274-0.50419-4}, DOI={10.1016/b978-0-443-15274-0.50419-4}, abstractNote={In this work, a model is developed and implemented for GFPUV production with aerobic fed-batch fermentation of E coli BL21 (DE3). The model parameters are estimated using historical process data and minimizing the prediction and measurement error. The model implements an extended Kalman filter for non-linear state estimation of biomass, glucose, and dissolved oxygen concentration. The filter includes an existing cascade feed-back loop for dissolved oxygen control which improves the predictive accuracy of the filter. The estimator is used during fermentation to predict the induction point based on a threshold glucose concentration which is otherwise determined exclusively with at-line measurements. The validation examples presented in this work show great agreement between the estimated and measured glucose concentrations, making it a useful tool for predicting the time until induction without requiring high-frequency at-line sampling.}, booktitle={Computer Aided Chemical Engineering}, publisher={Elsevier}, author={Stevnsborg, Mads and Selle, Kurt and Barton, Ryan and Prado-Rubio, Oscar A. and Gargalo, Carina and Gernaey, Krist V. and Gilleskie, Gary and Huusom, Jakob K.}, year={2023}, pages={2637–2642} }
 @article{wenning_shastry_barbieri_prodromou_greback-clarke_smith_moore_kilgore_cummings_pancorbo_et al._2023, title={Peptide ligands for the affinity purification of adeno-associated viruses from HEK 293 cell lysates}, volume={2}, url={https://doi.org/10.1101/2023.02.19.529155}, DOI={10.1101/2023.02.19.529155}, abstractNote={Abstract}, publisher={Cold Spring Harbor Laboratory}, author={WENNING, CHU and Shastry, Shriarjun and Barbieri, Eduardo and Prodromou, Raphael and Greback-Clarke, Paul and Smith, Will and Moore, Brandyn and Kilgore, Ryan and Cummings, Christopher and Pancorbo, Jennifer and et al.}, year={2023}, month={Feb} }
 @article{chu_shastry_barbieri_prodromou_greback-clarke_smith_moore_kilgore_cummings_pancorbo_et al._2023, title={Peptide ligands for the affinity purification of adeno-associated viruses from HEK 293 cell lysates}, volume={7}, ISSN={["1097-0290"]}, DOI={10.1002/bit.28495}, abstractNote={Abstract}, journal={BIOTECHNOLOGY AND BIOENGINEERING}, author={Chu, Wenning and Shastry, Shriarjun and Barbieri, Eduardo and Prodromou, Raphael and Greback-Clarke, Paul and Smith, Will and Moore, Brandyn and Kilgore, Ryan and Cummings, Christopher and Pancorbo, Jennifer and et al.}, year={2023}, month={Jul} }
 @article{shastry_wenning_barbieri_greback-clarke_smith_cummings_minzoni_pancorbo_gilleskie_ritola_et al._2023, title={Rational design and experimental evaluation of peptide ligands for the purification of adeno-associated viruses via affinity chromatography}, url={https://doi.org/10.22541/au.168482798.87003310/v1}, DOI={10.22541/au.168482798.87003310/v1}, abstractNote={Adeno-associated viruses (AAVs) have acquired a central role in modern
medicine as delivery agents for gene therapies targeting rare diseases.
While new AAVs with improved tissue targeting, potency, and safety are
being introduced, their biomanufacturing technology is lagging. The AAV
purification pipeline, in particular, hinges on protein ligands for the
affinity-based capture step: while featuring excellent AAV binding
capacity and selectivity, these ligands require strong acid (pH
<3) elution conditions, which can compromise the product’s
activity and stability; additionally, their high cost and limited
lifetime has a significant impact on the price tag of AAV-based
therapies. Seeking to introduce a more robust and affordable – yet
equally effective – affinity technology, this study introduces a cohort
of peptide ligands that (i) mimic the biorecognition activity of the AAV
receptor (AAVR) and anti-AAV antibody A20, while (ii) enabling product
elution under near-physiological conditions (pH 6.0) and (iii) granting
extended reusability by withstanding multiple regenerations. A20-mimetic
CYIHFSGYTNYNPSLKSC and AAVR-mimetic CVIDGSQSTDDDKIC demonstrated
excellent capture of serotypes belonging to distinct clones/clades –
AAV1, AAV2, AAV5, AAV6, AAV8, and AAV9 – corroborating the in silico
models documenting their ability to target regions of the viral capsid
that are conserved across all serotypes. CVIDGSQSTDDDKIC-Toyopearl resin
features binding capacity (~1014 vp per mL) and product
yields (~60-80%) on par with commercial adsorbents, and
purified AAV2 from HEK293 and Sf9 cell lysates affording high recovery
(up to 78%) and reduction of host cell proteins (up to 700-fold), and
high transduction activity (up to 65%) of the purified vectors.}, author={Shastry, Shriarjun and WENNING, CHU and Barbieri, Eduardo and Greback-Clarke, Paul and Smith, William and Cummings, Christopher and Minzoni, Ariann and Pancorbo, Jenifer and Gilleskie, Gary and Ritola, Kimberly and et al.}, year={2023}, month={May} }
 @article{shastry_chu_barbieri_greback-clarke_smith_cummings_minzoni_pancorbo_gilleskie_ritola_et al._2023, title={Rational design and experimental evaluation of peptide ligands for the purification of adeno-associated viruses via affinity chromatography}, volume={9}, ISSN={["1860-7314"]}, DOI={10.1002/biot.202300230}, abstractNote={Abstract}, journal={BIOTECHNOLOGY JOURNAL}, author={Shastry, Shriarjun and Chu, Wenning and Barbieri, Eduardo and Greback-Clarke, Paul and Smith, William K. and Cummings, Christopher and Minzoni, Arianna and Pancorbo, Jennifer and Gilleskie, Gary and Ritola, Kimberly and et al.}, year={2023}, month={Sep} }
 @article{boi_malavasi_carbonell_gilleskie_2022, title={A direct comparison between membrane adsorber and packed column chromatography performance (vol 1612, 460629, 2020)}, volume={1666}, ISSN={["1873-3778"]}, DOI={10.1016/j.chroma.2022.462852}, journal={JOURNAL OF CHROMATOGRAPHY A}, author={Boi, Cristiana and Malavasi, Andrea and Carbonell, Ruben G. and Gilleskie, Gary}, year={2022}, month={Mar} }
 @article{fahr_pena-benavides_thiel_sengoba_karacasulu_ihling_sosa-hernandez_gilleskie_woodley_parra-saldivar_et al._2022, title={Mobile On Demand COVID-19 Vaccine Production Units for Developing Countries}, volume={61}, ISSN={["0888-5885"]}, url={http://dx.doi.org/10.1021/acs.iecr.2c01217}, DOI={10.1021/acs.iecr.2c01217}, abstractNote={Two years into the COVID-19 pandemic and more than one year after the approval of the first vaccine, bottlenecks in production and supply chain infrastructure continue to delay vaccination campaigns in the Global South. Mobile on Demand (MOD) vaccine manufacture may help quickly ramp up production capacity while bypassing infrastructure bottlenecks. Such decentralized small-scale factories can help tip the scales in the battle against COVID-19 and future pandemics. In this work, we designed two MOD vaccine manufacturing units based on a protein antigen expressed in yeast and in vitro transcription of mRNA. Each unit consists of three shipping containers and can produce on the order of 10,000 vaccine doses daily for competitive prices and in close proximity of their end users. Abandoning economies of scale may lead to a moderate increase in production costs that may be outweighed by reduced closed-vial dose wastage and an earlier protection of vulnerable populations. © 2022 American Chemical Society.}, number={35}, journal={INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH}, publisher={American Chemical Society (ACS)}, author={Fahr, Steffen and Pena-Benavides, Samantha Ayde and Thiel, Lukas and Sengoba, Carl and Karacasulu, Kaan and Ihling, Nina and Sosa-Hernandez, Juan Eduardo and Gilleskie, Gary and Woodley, John M. and Parra-Saldivar, Roberto and et al.}, year={2022}, month={Aug} }
 @book{gilleskie_rutter_mccuen_2021, title={Biopharmaceutical Manufacturing}, ISBN={9783110616880}, url={http://dx.doi.org/10.1515/9783110616880}, DOI={10.1515/9783110616880}, abstractNote={Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:}, publisher={De Gruyter}, author={Gilleskie, Gary and Rutter, Charles and McCuen, Becky}, year={2021}, month={Aug} }
 @article{boi_malavasi_carbonell_gilleskie_2020, title={A direct comparison between membrane adsorber and packed column chromatography performance}, volume={1612}, ISSN={["1873-3778"]}, DOI={10.1016/j.chroma.2019.460629}, abstractNote={The purpose of this work was to compare side by side the performance of packed bed and membrane chromatography adsorption processes for protein purification. The comparison was performed using anion exchange media with the same ligand immobilized on the adsorbing surface, namely the strong Q quaternary ammonium group, R-CH2-N+-(CH3)3, and bovine serum albumin (BSA) as a model protein. In addition, the stationary phase volume was held constant for each geometry (3 mL) and runs were executed using the same mobile phase superficial velocity. As expected, the packed bed column showed higher equilibrium binding of BSA at 66.9 mg/mL versus 43.04 mg/mL for the membrane adsorber. Dynamic binding capacities were also higher in the packed bed; for example, at 97.5 cm/h, a capacity of 62.8 mg/mL was measured for the packed bed versus 20.7 mg/mL for the membrane adsorber. The higher equilibrium and dynamic capacities of the packed bed are likely due to the higher surface area per unit volume of the resin. However, the maximum productivity for the membrane adsorber was 111 mg/(mL h), a value that was 3.3 times higher than the one of the packed column. The bed utilization - defined as the ratio of the dynamic binding capacity at 10% breakthrough to the saturation binding capacity - was also higher for the packed column at long residence times and lower at short residence times confirming the better performance of membrane chromatography at high flow rates.}, journal={JOURNAL OF CHROMATOGRAPHY A}, author={Boi, Cristiana and Malavasi, Andrea and Carbonell, Ruben G. and Gilleskie, Gary}, year={2020}, month={Feb} }
 @article{karoshi_kolar_shah_gilleskie_2020, title={Recycled eggshells as precursors for iron-impregnated calcium oxide catalysts for partial oxidation of methane}, volume={7}, ISSN={["2197-4365"]}, DOI={10.1186/s40643-020-00336-4}, abstractNote={Abstract}, number={1}, journal={BIORESOURCES AND BIOPROCESSING}, author={Karoshi, Gourishankar and Kolar, Praveen and Shah, Sanjay B. and Gilleskie, Gary}, year={2020}, month={Aug} }
 @article{karoshi_kolar_shah_gilleskie_2020, title={Valorization of Eggshell Waste into Supported Copper Catalysts for Partial Oxidation of Methane}, volume={14}, ISSN={["2008-2304"]}, DOI={10.1007/s41742-019-00238-0}, number={1}, journal={INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH}, author={Karoshi, Gourishankar and Kolar, Praveen and Shah, Sanjay Bikram and Gilleskie, Gary}, year={2020}, month={Feb}, pages={61–70} }
 @article{a life cycle approach to education and training for the biopharmaceutical industry_2016, url={https://journals.flvc.org/cee/article/view/88298}, journal={Chemical Engineering Education}, year={2016} }
 @article{process-oriented training in single-use technology_2016, journal={BioProcess International Supplement Series}, year={2016} }
 @article{karoshi_kolar_shah_gilleskie_das_2015, title={Calcined eggshell as an inexpensive catalyst for partial oxidation of methane}, volume={57}, ISSN={["1876-1089"]}, DOI={10.1016/j.jtice.2015.05.025}, abstractNote={Calcined eggshell was evaluated as an inexpensive catalyst for selective oxidation of methane. Experiments were conducted using a packed bed reactor to determine the effects of oxygen on methane ratio (1, 3 and 7), flow rate (0.4, 0.8 and 1.2 L/min), and temperature (650, 700, and 750 °C) on methane conversion and selectivity. Our results suggested that partial oxidation of methane on calcined eggshell yielded higher hydrocarbons (C2–C7) via oxidative coupling with an average fractional methane conversion of ∼30%. Several factors including oxygen concentration, flow rate, and temperature were observed to influence fractional methane conversion and product selectivity. Catalyst characterization showed enhanced porosity and surface area upon calcination due to removal of organics and carbon dioxide. Surface deformation was observed in spent catalyst due to the physical impact of feed gas. Results from this research are expected to add value to eggshells and enhance agricultural waste management opportunities in areas where poultry industry is concentrated.}, journal={JOURNAL OF THE TAIWAN INSTITUTE OF CHEMICAL ENGINEERS}, author={Karoshi, Gourishankar and Kolar, Praveen and Shah, Sanjay B. and Gilleskie, Gary and Das, Lalitendu}, year={2015}, month={Dec}, pages={123–128} }
 @article{comparison of concentration measurement technologies in bioprocess solutions_2015, journal={BioProcess International}, year={2015} }
 @article{comprehensive hands-on training for biopharmaceutical manufacturing_2015, journal={BioProcess International}, year={2015} }
 @article{ruiz_gilleskie_brown_burnett_carbonell_2014, title={Comprehensive Hands-on Training for Influenza Vaccine Manufacturing: A WHO-BARDA-BTEC Partnership for Global Workforce Development}, volume={42}, ISSN={["1539-3429"]}, DOI={10.1002/bmb.20817}, abstractNote={Abstract}, number={5}, journal={BIOCHEMISTRY AND MOLECULAR BIOLOGY EDUCATION}, author={Ruiz, Jennifer and Gilleskie, Gary L. and Brown, Patty and Burnett, Bruce and Carbonell, Ruben G.}, year={2014}, pages={414–419} }
 @article{from process development to manufacturing: lab-intensive courses in downstream bioprocessing_2014, url={https://journals.flvc.org/cee/article/view/83365}, journal={Chemical Engineering Education}, year={2014} }
 @article{karoshi_kolar_shah_gilleskie_2014, title={Value-addition of methane via selective catalytic oxidation}, volume={5}, url={http://dx.doi.org/10.4155/bfs.14.1}, DOI={10.4155/bfs.14.1}, abstractNote={Selective oxidation of methane into fuels and chemicals has attracted significant attention from researchers worldwide. However, because of its high stability, methane conversion involves multistep reactions. Hence, several catalytic approaches including homogeneous, heterogeneous biological and photocatalytic methods have been explored to selectively oxidize methane into methanol, and other chemicals such as ethane, ethylene and formaldehyde. The purpose of this Review is to discuss the current technologies and catalysts associated with selective oxidation of methane, reaction variables that influence selectivity and conversion, and challenges and available opportunities with methane conversion technologies. In addition, a few ideas to enhance the selectivity and conversion of methane are also presented.}, number={2}, journal={Biofuels}, publisher={Informa UK Limited}, author={Karoshi, Gourishankar and Kolar, Praveen and Shah, Sanjay B and Gilleskie, Gary}, year={2014}, month={Mar}, pages={175–188} }
 @article{biopharmaceutical microbial contamination control_2013, journal={Pharmaceutical Processing}, year={2013} }
 @article{gilleskie_parker_cussler_1995, title={Gas separations in hollow-fiber adsorbers}, volume={41}, url={http://dx.doi.org/10.1002/aic.690410608}, DOI={10.1002/aic.690410608}, abstractNote={Abstract}, number={6}, journal={AIChE Journal}, publisher={Wiley}, author={Gilleskie, Gary L. and Parker, Jennifer L. and Cussler, E. L.}, year={1995}, month={Jun}, pages={1413–1425} }
 @article{pressure swing adsorption in hollow fibers immersed in liquid_1992, journal={Separations Technology}, year={1992} }
 @article{ganesan_lloyd_gilleskie_lim_1989, title={SEGREGATION AND CHEMICAL CONVERSION AT OIL-WATER INTERFACE}, volume={44}, ISSN={["0009-2509"]}, url={http://dx.doi.org/10.1016/0009-2509(89)85242-x}, DOI={10.1016/0009-2509(89)85242-x}, abstractNote={Abstract Experimental evidence and theoretical consideration are presented to draw attention to the adsorptive power of the oil-water interface and the promising potential it provides for the development of an interfacial emulsion technique that can be useful for separation and materials conversion. It is shown that dissolved and suspended materials can be segregated into a compact emulsion in between water and an immiscible oil phase, and that such segragation facilitates the separation or conversion of the materials. On account of its property range being wider than that of solid-water and gas-water interfaces, the oil-water interface could provide a flexibility and versatility that would make the envisioned emulsion technique more useful than packed-bed and foam techniques. Other possible advantages may include a high capacity and high enrichment, and the availability of surface variation as a convenient process parameter.}, number={1}, journal={CHEMICAL ENGINEERING SCIENCE}, publisher={Elsevier BV}, author={GANESAN, S and LLOYD, PB and GILLESKIE, GL and LIM, PK}, year={1989}, pages={171–177} }