Authors
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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.
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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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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.
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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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Scotland: Ushering in the next age of life sciencesScotland is a recognized leader in stem cell research, neuroscience, cancer research, genomics, proteomics, and bioinformatics.
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Strategies to Improve Vaccines for the NeonatePotential interference with maternally-derived antibodies makes most vaccines less effective in the neonate.
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Precipitation of Process-Derived Impurities in Non-Protein A Purification Schemes for AntibodiesPrecipitation prior to capture chromatography offers a simple, robust, and economical method to remove CHO host cell proteins and DNA.
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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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Technology Transfer: How to Make It a Competitive AdvantageIf a company wants to reduce costs, it should consider outsourcing some manufacturing and analytical testing to low-cost sites.
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Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.
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.
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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Rapid High-Throughput Feed OptimizationGrowth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.
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Rapid High-Throughput Feed OptimizationGrowth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.
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Predicting Extractables and Leachables from Container StoppersData from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.
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Chromatography: A Two-Column Process To Purify Antibodies Without Protein AThis flexible setup minimizes the number of purification process steps, buffers, and process components.
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Manufacturing Vaccines in Adherent Cell Lines Using Disposable Multi-tray BioreactorsThe recent growth in the vaccine market has led to renewed interest in using adherent human cell lines for vaccine production. Traditionally, small-scale adherent cell line production has been carried out in roller bottles or T-flasks. Over the past few years, however, a number of companies have found multi-tray disposable bioreactors an effective method for producing high-quality drug products using adherent cells. These disposable, expandable systems have also facilitated scale up from laboratory to clinical-scale.
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Avoiding the Train WreckThe "due diligence framework" is an efficient process. But efficient is not the same as quick and easy. There are no shortcuts. The framework minimizes resource commitments and disruptions to ongoing programs and helps each side learn what it needs to know. In six steps, it converts the typical due diligence root canal into a painless filling.
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Rapid High-Throughput Feed OptimizationGrowth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.
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The Company at the Crossroads. Part 2: Build or Buy?When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.
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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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Precipitation of Process-Derived Impurities in Non-Protein A Purification Schemes for AntibodiesPrecipitation prior to capture chromatography offers a simple, robust, and economical method to remove CHO host cell proteins and DNA.
