Authors
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QbD: Convincing the SkepticsWithout a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.
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Standardized, Hands-on Biomanufacturing Training is EssentialThe development of a skilled labor force is essential for an expanding biopharmaceutical industry.
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Strategies for Sourcing Animal-Origin Free Cell Culture Media ComponentsHow to successfully balance patient safety with supply-chain management
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Detection of Cache Valley Virus in Biologics Manufactured in CHO CellsAvoid manufacturing failures by effective viral inactivation.
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Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
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Purification of IgM Monoclonal AntibodiesManufacturing challenges surround the use of IgM monoclonal antibodies, but these can be overcome with current technology.
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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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Coming to a Biotech Near You: Quality by Design Part 2: Design Space in Development and ManufacturingQuality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.
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A Purification Platform for the Production of MAbs from Fermenters with Titers of 5 g/L and BeyondNew techniques can overcome bottlenecks in existing facilities.
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Benefits of Effective Communication with a Contract Analytical LaboratoryCommunication between contract analytical laboratory and client is extremley important when out-of-specification (OOS) results arise.
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Disposable Bioreactors for Cells and MicrobesProductivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors.
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Bioprocessing Technology Trends of RNA-Based Therapeutics and VaccinesThe authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.
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Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
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Getting the Results You Expect from ConsultantsThere are several steps that you can take to ensure that you get the greatest benefit from consultants.
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Purification Strategies to Process 5 g/L Titers of Monoclonal AntibodiesAltering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.
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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.
