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A New Era in Cell Culture Media DevelopmentCell-line specific complex media supplements combine chemically defined media additives into a single supplement.
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Modeling of Biopharmaceutical Processes—Part 1: Microbial and Mammalian Unit OperationsProcess-modeling tools can ensure smooth tech transfer.
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Considerations for Scaling-up Depth Filtration of Harvested Cell Culture FluidData on the performance and variability of different formats.
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Fusion Tags for Protein Expression and PurificationGene fusion tags can improve the yield and solubility of many recombinant proteins. This article discusses the most popular fusion tags and the proteases used to remove them, with special reference to recently introduced technologies.
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Improving Protein Production in CHO CellsUsing chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly.
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How to Avert Supply-Chain Quality FailuresTo stave off quality issues associated with production processes, a centralized and enterprise-wide quality management initiative must be enforced.
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Lifecycle Cost Analysis for Single-Use SystemsThis article describes a quick method for evaluating lifecycle costs for single-use systems against their more conventional stainless-steel counterparts.
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Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
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Antibody Purification Using Membrane AdsorbersA membrane adsorber in retention mode can be used efficiently in a commercial antibody manufacturing process.
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Recombinant Protein Production Yields from Mammalian Cells: Past, Present, and FutureA discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells.
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Plasmid DNA Recovery Using Size-Exclusion and Perfusion ChromatographyScalable method to recover plasmid-DNA.
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Improving Protein Production in CHO CellsUsing chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly.
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Systematic Evaluation of Single-Use Systems Using Process Simulation ToolsThis article describes the steps required to build a comprehensive model in a batch process simulator for a process that uses single-use systems for buffer preparation and storage.
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The Development and Application of a Monoclonal Antibody Purification PlatformA purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
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Intact Mass Analysis of Multispecific Antibodies: Automation and Data ManagementTuesday, October 25th, 2022 at 11am EDT|8am PDT|4pm BST|5pm CEST Discover approaches for medium- and high-throughput analysis of multispecific antibodies using Byos software with AWS automation workflows. In this presentation, we will discuss how to use this data to select optimal therapeutic candidates produced on our high-throughput protein production platform.
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Recombinant Protein Production Yields from Mammalian Cells: Past, Present, and FutureA discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells.
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Fusion Tags for Protein Expression and PurificationGene fusion tags can improve the yield and solubility of many recombinant proteins. This article discusses the most popular fusion tags and the proteases used to remove them, with special reference to recently introduced technologies.
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Considerations When Outsourcing the Production of Clinical MaterialIt is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.
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A Case Study of Developing Analytical MethodsContract manufacturers must plan for increased analytical resources in development and quality control.
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Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
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Developing the Future: Big Questions, Multiple AnswersWhen you don't know the answer to a question, ask an expert. If the question is really big, ask more experts. If you have a collection of difficult questions, run a poll of many experts. That, in effect, was the impetus for Eden Biodesign to survey 670 BioPharm International subscribers with questions as to what will be the development mechanism to achieve safe, effective, and cheap new medicines.
Latest:
Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
Latest:
Recombinant Protein Production Yields from Mammalian Cells: Past, Present, and FutureA discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells.
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Top 10 Legal Issues Biotech Start-Ups Must AddressA top-10 list of critical legal issues that biotech start-ups should make an effort to address, even when the capital squeeze is intense.
Latest:
Systematic Evaluation of Single-Use Systems Using Process Simulation ToolsThis article describes the steps required to build a comprehensive model in a batch process simulator for a process that uses single-use systems for buffer preparation and storage.
Latest:
Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
