Authors
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Changing Your Business ModelBioPharm talks with Tarja Mottram, CEO of Action for Results, on design-for-value concepts, management, and cross-functionality.
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Modeling the Efficacy of HTST for Inactivating Mouse Minute VirusThe authors investigate the sufficiency of high-temperature short-time treatment in inactivate mouse minute virus contamination.
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Criteria for Selecting a CMO: A Case Study"A systematic approach taken by a company involved making an assessment of internal capabilities, strengths, and needs before the selection process."
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Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
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Establishing a Successful CRO–Client RelationshipIt is essential to build and maintain a good working relationship between the client and contract research organization.
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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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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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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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Scale up of Fed-Batch Culture to Produce Plasmid DNA in Escherichia coli (Peer Reviewed)The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.
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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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Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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Pharmaceutical Quality Success: It's All About ManagementEngaging executive leadership in the quality process is the key to compliance success.
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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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Considerations for Scaling-up Depth Filtration of Harvested Cell Culture FluidData on the performance and variability of different formats.
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Maximizing Yields of Plasmid DNA ProcessesRecombinant protein and plasmid DNA production using microbial expression systems is the cornerstone of many biologics manufacturing processes. HCD methods are commonly used for these processes because of the advantages they provide.
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Speed and Efficiency in Designing and Building a Monoclonal Antibodies Pilot PlantA close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.
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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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The Case for Outsourcing Biologics Process DevelopmentFour reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.
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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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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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Plasmid DNA Recovery Using Size-Exclusion and Perfusion ChromatographyScalable method to recover plasmid-DNA.
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Speed and Efficiency in Designing and Building a Monoclonal Antibodies Pilot PlantA close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.
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Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory PerspectiveFDA perspectives on specs and effective control strategies.
