Authors
Latest:
The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional VaccinesIn animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.
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Optimized Vaccine Development and Manufacturing: A Technology OverviewThe replacement of a IgG ELISA assay with an SPR-based test can shorten the production workflow by one day.
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Back to the FutureOne company even connected hollow fiber cell culture chambers to living cows.
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Supplementary Material for Allogeneic Versus Autologous Stem-Cell Therapy: Manufacturing Costs and Commercialization StrategiesThis article contains online-exclusive supplemental material for Malik's article entitled, "Allogenic Versus Autologous Stem-Cell Therapy."
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Patents: Patent Strategies for Biotechnology EnterprisesCompanies in the biotech industry typically require one or several partners as they complete the product development cycle.
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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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Pandemic Flu Preparedness: A Manufacturing PerspectiveFor pandemic vaccine processing, single-use filter cartridges and membrane chromatography technologies could offer significant time- and cost-reduction advantages.
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Characterization of Aluminum Hydroxide Gel and Oil-in-Water Emulsion Formulations Containing CpG ODNsAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Process Lifecycle Validation: Applying Risk ManagementThe authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.
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Outsourcing: Managing Your Contractor Relationship—A Smart InvestmentCompanies need to avoid operating in a manner that is inconsistent with the priorities established in the strategic sourcing decision.
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Disposable Biopharmaceutical Processes–Myth or Reality?Biopharmaceutical processes typically require a significant investment in equipment-often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy.
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Outsourcing: Transition from Business Process Outsourcing to Knowledge Process OutsourcingBy outsourcing high-end processes that demand advanced analytical and technical skills, biopharm companies are reaping substantial savings.
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Quality by Design in the CMO EnvironmentHow the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.
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The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional VaccinesIn animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.
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Biotech Manufacturing Grows UpIt became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable.
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Principles and Practical Steps to Develop Robust Reversed Phase Separations of PeptidesWebinar Dates/Times: Session 1 (EU): Wednesday, May 17th, 2023 at 2pm BST | 3pm CEST | 9am EDT Session 2 (NA): Wednesday, May 17th, 2023 at 1pm EDT | 10am PDT | 6pm BST Session 3 (APAC): Thursday, May 18th, 2023 at 12pm JST | 11am CST | 11pm EDT
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New-Age Vaccine Adjuvants: Friend or Foe?Adjuvant-caused vaccine reactions are one of the most important barriers to better acceptance of routine prophylactic vaccination.
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Production Cost Analysis: Economic Analysis as a tool for Process Development: Harvest of a High Cell-Density FermentationThe number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust.
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Devising an International Clinical Trial Distribution Strategy: Genentech's ApproachA decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term.
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Considerations in Identification and Qualification of Spectrophotometer Equipment for Microbial FermentationsThe authors outline qualification procedures for a process-critical piece of equipment.
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New-Age Vaccine Adjuvants: Friend or Foe?Adjuvant-caused vaccine reactions are one of the most important barriers to better acceptance of routine prophylactic vaccination.
Latest:
The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional VaccinesIn animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.
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Outsourcing: Offshoring to China: What Should Your Model Be?Offshoring to China has captured the imagination of Western managers seeking to reduce operating costs. What is the best approach?
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Cell-Culture–Based Manufacturing: Meeting the Challenge of 21st Century InfluenzaVaccines against strains originating from avian flu may achieve poor yields in egg-based systems. Consequently, both public and private interest in alternative systems is high.
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CONTINUOUS PROCESSING: The Multicolumn Countercurrent Solvent Gradient Purification ProcessThis article presents the multicolumn countercurrent solvent gradient purification (MCSGP) process, which uses three chromatographic columns, and incorporates the principle of countercurrent operation and the possibility of using solvent gradients. A MCSGP prototype has been built using commercial chromatographic equipment. The application of this prototype for purifying a MAb from a clarified cell culture supernatant using only a commercial, preparative cation exchange resin shows that the MCSGP process can result in purities and yields comparable to those of purification using Protein A.
