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Bioreactor control systems in the biopharmaceutical industry:a critical perspective

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Systems Microbiology and Biomanufacturing 2022年第1期2卷 91-112页

作者： Sagnik Mitra Ganti S.Murthy Department of Biosciences and Biomedical Engineering Indian Institute of Technology IndoreIndore 453552India

Industrial-scale bioprocessing underpins much of the production of pharmaceuticals,nutraceuticals,food,and beverage processing industries of the modern *** proftability of these processes increasingly leverages the economies of scale and scope that are critically dependent on the product yields,titers,and *** of the processes are controlled using classical control approaches and represent over 90%of the industrial controls used in bioprocessing ***,with the advances in the production processes,especially in the biopharmaceutical and nutraceutical industries,monitoring and control of bioprocesses such as fermentations with GMO organisms,and downstream processing has become increasingly complex and the inadequacies of the classical and some of the modern control systems techniques is becoming ***,with increasing research complexity,nonlinearity,and digitization in process,there has been a critical need for advanced process control that is more efective,and easier process intensifcation and product yield(both by quality and quantity)can be *** this review,industrial aspects of a process and automation along with various commercial control strategies have been extensively discussed to give an insight into the future prospects of industrial development and possible new strategies for process control and automation with a special focus on the biopharmaceutical industry.

关键词： Bioreactor control systems Digitization Advanced process control Industrial automation Single-use technology biopharmaceuticals

Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies

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Journal of Pharmaceutical Analysis 2020年第1期10卷 23-34页

作者： Sara Carillo Raquel Peerez-Robles Craig Jakes Meire Ribeiro da Silva Silvia Millan Martín Amy Farrell Natalia Navas Jonathan Bones Characterisation and Comparability Laboratory NIBRT e the National Institute for Bioprocessing Research and TrainingFoster AvenueMount MerrionBlackrockCo.DublinA94 X099Ireland Department of Analytical Chemistry Biohealth Research Institute(ibs.GRANADA)University of GranadaGranadaSpain School of Chemical and Bioprocess Engineering University College DublinBelfieldDublin 4D04 V1W8Ireland

With the size of the biopharmaceutical market exponentially increasing,there is an aligned growth in the importance of data-rich analyses,not only to assess drug product safety but also to assist drug development driven by the deeper understanding of structure/function *** monoclonal antibodies,many functions are regulated by N-glycans present in the constant region of the heavy chains and their mechanisms of action are not completely *** importance of their function focuses analytical research efforts on the development of robust,accurate and fast methods to support drug development and quality *** N-glycan analysis is considered as the gold standard for glycosylation characterisation;however,it is not the only method for quantitative analysis of glycoform *** this study,ten different analytical workflows for N-glycan analysis were compared using four monoclonal *** observing good comparability between the quantitative results generated,it was possible to appreciate the advantages and disadvantages of each technique and to summarise all the observations to guide the choice of the most appropriate analytical workflow according to application and the desired depth of data generated.

关键词： N-Glycans biopharmaceuticals Monoclonal antibodies Intact mass analysis Mass spectrometry Native mass spectrometry Glycan analysis Peptide mapping Glycopeptide analysis

Application of naturalβ-glucans as biocompatible functional nanomaterials

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Food Science and Human Wellness 2019年第4期8卷 315-319页

作者： Xiaojie Li Peter Chi Keung Cheung Food and Nutritional Sciences School of Life SciencesThe Chinese University of Hong KongHong KongChina

Naturally-occurringβ-glucans are mostly investigated for their antitumor activity and immunomodulatory *** have been widely regarded as a natural source for functional foods and ***,the physico-chemically stable and biocompatible properties ofβ-glucans are rarely explored as a coating material for nanomaterials to overcome the problems of aggregation and *** article reviews on the exploration ofβ-glucans,in particular those derived from mushrooms,as a natural coating material to modify the surface properties of bioactive substances as a relatively simple and cost-effective strategy to produce stable and biocompatible nanohybrids used for biopharmaceutical *** is envisaged that suchβ-glucan-based coating method will provide new opportunities to design biocompatible functional nanomaterials for wider clinical applications.

关键词： β-Glucans Biocompatibility biopharmaceuticals Nanohybrids

Study and ICH validation of a reverse-phase liquid chromatographic method for the quantification of the intact monoclonal antibody cetuximab

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Journal of Pharmaceutical Analysis 2016年第2期6卷 117-124页

作者： Antonio Martinez-Ortega Agustin Herrera Antonio Salmeron-Garcia Jose Cabeza Luis Cuadros-Rodriguez Natalia Navas Department of Analytical Chemistry University of Granada Faculty of Science Campus Fuentenueva s/n E-18071 Granada Spain UGC intercentro Interniveles Farmacia Granada San Cecilio Hospital Biomedical Research Institute ibs. GRANADA. Hospitales Universitarios de Granada University of Granada E-18012 Granada Spain Department of Analytical Chemistry Science Faculty Biomedical Research Institute ibis. GRANADA University of Granada Campus Fuentenuevo s/n E-18071 Granada Spain

Cetuximab （CTX） is a potent chimeric mouse/human monoclonal antibody （mAb） approved worldwide for treatment of metastatic colorectal cancer. Among the various biological and physical analyses per- formed for full study on this biopharmaceutic, the determination of the concentration preparations throughout manufacturing and subsequent handling in hospital is particularly relevant. In the present work, the study and validation of a method for quantifying intact CTX by reverse-phase high-perfor- mance liquid chromatography with diode array detection （（RP）HPLC/DAD） is presented. With that end, we checked the performance of a chromatographic method for quantifying CTX and conducted a study to validate the method as stability-indicating in accordance with the International Conference on Harmo- nization guidelines （ICH） for biotechnological drugs; therefore, we evaluated linearity, accuracy, preci- sion, detection and quantification limits, robustness and system suitability. The specificity of the method and the robustness of the mAb formulation against external stress factors were estimated by compre- hensive chromatographic analysis by subjecting CTX to several informative stress conditions. As de- monstrated, the method is rapid, accurate, and reproducible for CTX quantification. It was also suc- cessfully used to quantify CTX in a long-term stability study performed under hospital conditions.

关键词： Reverse-phase high performance liquidchromatography Diode detector Stress study biopharmaceuticals Cetuximab

Theory of Global Sustainable Development Based on Microalgae in Bio and Industrial Cycles, Management-Changing Decisions in Areas of Climate Change and Waste Management

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Journal of Sustainable Bioenergy Systems 2013年第4期3卷 287-297页

作者： Armen B. Avagyan Research & Industry Centre of Photosynthesizing Organisms Feed Additives and Physiologically Active Compounds Yerevan Armenia

The paper provides requested management-changing decisions through implementation of conclusions of Global Sustainable Development theory based on including of microalgae in Bio and Industrial Cycles in the area of waste-related management challenges within creating market opportunities for industry through expansion of resource efficiency use across global supply chains and new design and building sustainable development with contemporary manufacturing of value added products. A truly coherent waste management and other production policy (biofuel, biopharmaceuticals, food, feed and perfumery additives) and mitigation of Climate Change are ways to bring these traces closer to cost effective manufacturing, improving of resource efficiency use, well being economy and human health. Offered technological change dramatically increase biomass feedstock resources, reduce waste origin of greenhouse emission (since 13%-17%), organics sent to landfill, pyrolyses, etc. and create a model that all elements along the waste value chain create economic, societal and/or environmental value.

关键词： Microalgae Global Sustainable Development Climate Change Waste Management Biofuel Feed and Perfumery Additives biopharmaceuticals

Engineering Plants as Platforms for Production of Vaccines

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American Journal of Plant Sciences 2020年第5期11卷 707-735页

作者： Sujatha Thankeswaran Parvathy ICAR-Indian Institute of Agricultural Biotechnology Ranchi Jharkhand India

Microbial pathogens have always posed serious threats and challenges to human existence. Pathogenic microbes causing epidemic and pandemic outbreaks have the potential of effacing life on earth. Vaccines are used as prophylactic as well as treatment measures against diseases and are effective in eradicating deadly pathogens. Conventional vaccines though effective, have high production costs, involve tedious purification processes and have biosafety issues, requiring time-consuming biosafety tests for commercial production. Plant-based vaccines offer several advantages over the conventional systems such as ease of production, storage, higher yields, stability and safety. The review discusses significance, advantages, comparisons, prospects and challenges or constraints in the production of plant-based vaccines and antibodies.

关键词： Plant Vaccines biopharmaceuticals Molecular Farming Bioreactors Regulations