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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.
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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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Final Word: BIO: The Olympics of BiotechPlan ahead to make the most of every opportunity at this year?s BIO convention in San Francisco.
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Copyrights and TrademarksTrademark protection in the US is based on a dual system of federal and state laws.
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Cleaning Polyethersulfone Membranes After Ultrafiltration-Diafiltration in Monoclonal Antibody ProductionIn the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.
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Copyrights and TrademarksTrademark protection in the US is based on a dual system of federal and state laws.
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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.
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The Human Side of PartnershipsHe potential for frustration, time-wasting, and bad feelings between pharma and biotech partners is enormous. That some successful decisions are made under these circumstances is something of a miracle.
