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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.
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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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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.
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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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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:
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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Protecting Patents for Personalized MedicineThere are several challenges associated with protecting patents for personalized medicines.
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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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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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Advances in Single-Shot Vaccine DevelopmentThe disadvantages of the traditional vaccine regime (prime plus boost) have spurred the development of single-shot vaccines. This article describes the development and manufacture of a prototype single-shot vaccine that uses microspheres made from cross-linked modified dextran polymers for controlled release of the antigen.
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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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Integrating CMC Document Preparation into the Development Process for Vaccine INDsVaccine process development is complex, and so are the documents required before clinical trials begin. Technical writers and editors can effectively coordinate the timely authoring, reviewing, and auditing of regulatory documents, minimizing filing delays.
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Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process PerformanceUnderstanding the impact on process performance.
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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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The Environmental Impact of Disposable TechnologiesCan disposables reduce your facility's environmental footprint? We have compared the environmental footprint of a traditional biopharmaceutical manufacturing facility using fixed-in-place stainless steel equipment, and a facility implementing disposable technologies for cell culture, solution mixing and hold, product hold, and liquid transfer.
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Optimizing the Primary Recovery Step in Nonaffinity Purification Schemes for HuMAbsAn alternative approach to traditional Protein A schemes is comparable in overall efficiency, product recovery, and quality.
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The Environmental Impact of Disposable TechnologiesCan disposables reduce your facility's environmental footprint? We have compared the environmental footprint of a traditional biopharmaceutical manufacturing facility using fixed-in-place stainless steel equipment, and a facility implementing disposable technologies for cell culture, solution mixing and hold, product hold, and liquid transfer.
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Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
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Harvest and Recovery of Monoclonal Antibodies from Large-Scale Mammalian Cell CultureA comparison of primary harvest techniques.
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The Purification of Plasmid DNA for Clinical Trials Using Membrane ChromatographyMembrane chromatography ensures purity at high flow rates.
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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.
