Authors
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A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
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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.
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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Plasmid DNA–Based Vaccines: Combating Infectious DiseasesLike the egg-based vaccine production process, producing a vaccine under cGMP conditions using mammalian cells can be a lengthy process, taking a minimum of six to 12 months.
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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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Due Diligence Assessment of CMC ActivitiesFor planned acquisitions or licensing, careful analysis of CMC factors ensures no problem areas are overlooked.
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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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Properties of Materials Used in Single-Use Flexible Containers: Requirements and AnalysisThe adoption of single-use containers in the biopharmaceutical industry is becoming more frequent as the popularity and availability of the technologies increase. The choice of a solution for storage in single-use containers clearly depends on the application and the inherent risks associated with the application. A "one fits all" single-use system cannot respond to all the requirements of a particular step in a biopharmaceutical process, much less to all the steps of a process. The needs of an application will lead to very specific single-use solutions.
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Facility Design: Simulation Methodology for Facility DesignDiscrete simulation allows the design teams to see every meaningful detail about equipment and materials flowing through the process.
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Advancing Vaccine Technology to Combat Global Pandemic ThreatsNew technologies such as virus-like particles are promising weapons in the battle against pandemic influenza.
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Can the FDA Live up to its Promise of a Risk-Based Approach to Compliance?The expanding globalization of the industry poses a challenge for international enforcement.
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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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Vaccine Characterization Using Advanced TechnologyWith the advent of high-resolution mass spectrometers and highly sensitive MS instruments, vaccine characterization has entered a new phase.
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Cancer Vaccines: Asymptotically Approaching Product ApprovalFor many cell-based vaccines, the precursor monocytes or CD34+ cells are cultured with cytokines to obtain dendritic cells, which are very potent antigen-presenting cells (APCs).
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Plasmid DNA–Based Vaccines: Combating Infectious DiseasesLike the egg-based vaccine production process, producing a vaccine under cGMP conditions using mammalian cells can be a lengthy process, taking a minimum of six to 12 months.
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Advances in Animal-Free Manufacturing of BiopharmaceuticalsIn addition to existing guidance, in January 2007 the FDA announced further proposals to prohibit the use of certain bovine materials as ingredients in some medical products or as elements of product manufacturing.
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Producing Proteins Using Transgenic Oilbody-Oleosin TechnologyTransgenics can substantially reduce capital investment and lower production costs through economies of scale and more flexible scale-up.
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Radical Changes in the Engineering of Synthetic Genes for Protein ExpressionManaging codon pair interactions and simultaneously optimizing the entire set of parameters requires advanced computationally intensive design tools.
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Chromatography Process Development Using 96-Well Microplate FormatsUsing packed columns in process development activities limits the scope for appraising a large and diverse range of media.
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Final Word: The US is Falling Behind on Generic BiopharmaceuticalsWithout generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals.
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Investing, Innovating, InspiringIreland's dynamic life sciences industry attracts investors, both foreign and domestic, and lures its brightest minds back home.
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Producing Proteins Using Transgenic Oilbody-Oleosin TechnologyTransgenics can substantially reduce capital investment and lower production costs through economies of scale and more flexible scale-up.
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Disposables: Keeping Pace with Today's Disposable Processing ApplicationsFrequently asked questions on implementing and using single-use technologies
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GLPs and the Importance of Standard Operating ProceduresGood laboratory practice is the central dogma of all laboratory research and investigation - it's your commitment to regulators - and poor laboratory controls are a common cause of 483 observations and preapproval inspection failures.
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Immunogenicity of Biopharmaceuticals: An Example from ErythropoietinSubcutaneous administration is likely to be an important factor in generating an immunogenic response.
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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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Enhanced Affinity Columns Simplify Protein FractionationThe concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.
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Domestic Patents - Questions You Should Ask Your Patent AttorneyYour research and development team has just shouted "Eureka!" after long and expensive years of research, exclaiming they have developed a next-generation pain reliever. What do you do next? This article explores and suggests your next steps and identifies pertinent questions to ask a patent attorney. The focus is on intellectual property; this article does not address the myriad regulatory issues that must be resolved.
