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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.
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GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological ReagentDevelopment guidelines for MAbs serve as a blueprint for their manufacture, safety, and efficacy testing.
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Strong government support, a talented workforce, and a thriving research environment drive life sciences excellence in ScotlandInternational partnerships, an attractive regulatory environment, and robust funding make Scotland a world leader in biotechnology.
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Efficiency Measurements for Chromatography ColumnsMisinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.
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Violet Diode-Assisted Photoporation and Transfection of CellsVarious methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
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Expression of Recombinant Proteins in YeastYeast systems have been a staple for producing large amounts of proteins for industrial and biopharmaceutical use for many years. Yeast can be grown to very high cell mass densities in well-defined medium. Recombinant proteins in yeast can be over-expressed so the product is secreted from the cell and available for recovery in the fermentation solution. Proteins secreted by yeasts are heavily glycosylated at consensus glycosylation sites. Thus, expression of recombinant proteins in yeast systems historically has been confined to proteins where post-translations glycosylation patterns do not affect the function of proteins. Several yeast expression systems are used for recombinant protein expression, including Sacharomyces, Scizosacchromyces pombe, Pichia pastoris and Hansanuela polymorpha.
