Authors
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Analytical Method Transfer Conditions Used by Global Biologics ManufacturersThe authors present the results of a survey of biologics manufacturers to evaluate how these manufacturers transfer analytical methods.
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Technical and Economical Evaluation of Downstream Processing Options for Monoclonal Antibody (Mab) ProductionDownstream process design can increase facility output through improved overall process yield or higher batch capacity in mass and volume.
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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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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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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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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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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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Applying Fusion Protein Technology to E. coliProtein expression remains an arduous task that involves a complex decision tree. Establishing tools and optimal conditions for each protein remains an empirical exercise.
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Making Site-specific PEGylation WorkThere are challenges aplenty in purification and analysis of PEGylated protein pharmaceuticals. Here are a variety of technical solutions, many concentrating on the chemistry of the linker.
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LicensingHistorically, the big pharmaceutical companies (Big Pharma) have sought to feed their marketing machines by manufacturing blockbuster drugs—chemical-based, one-type-fits-all products that treat chronic conditions such as heart disease or arthritis. This approach has yielded recurring revenue streams from large patient populations. In contrast, biotechnology companies typically have created protein-based drugs,or biologics, to treat acute or niche conditions and diseases. With few exceptions (such as the biotech giant Amgen), biotech companies have foregone doing the marketing and sales of their drugs themselves, and have, instead, relied on others to perform their marketing and sales functions.
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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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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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Where is Biopharmaceutical Manufacturing Heading?An analysis of current and upcoming industry challenges.
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Technical and Economical Evaluation of Downstream Processing Options for Monoclonal Antibody (Mab) ProductionDownstream process design can increase facility output through improved overall process yield or higher batch capacity in mass and volume.
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Bioanalytical Development ToolsNearly every process conducted in a biotechnology company requires analytical methods to back it up. Since BioPharm's last guide published in December 2001,1 scientists have developed exciting, new tools for conducting research. Listed here is a sampling of new technological developments unveiled in 2005.
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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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A 25-Year Retrospective on Bio-EngineeringSteven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."
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Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFPHuman plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin, and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of new therapeutic products have recently been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring, and Octagam from Octapharma.
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Development of a Novel Platform TFF System for Insect Cell Culture HarvestThe overall average flux rate for the concentration and diafiltration step was 41 L m–2 h–1.
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The FDA is Here! A Primer on What To ExpectPresenting documentation in a timely manner will expedite the inspection process and provide a positive impression to agency representatives.
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Efficient Small-Scale Production of ProteinsOver the last three decades, numerous protein expression systems have been developed with various quality requirements on large and small scales. Huge steps have been made in large-scale protein production in mammalian systems while the small-scale mammalian systems are expensive and inflexible. Thus, small-scale production is done in simpler expression systems, sometimes sacrificing the quality of the proteins. However, relief is on the way.
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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 Solve Tomorrow's Manufacturing ProblemsDisposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination.
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The FDA is Here! A Primer on What To ExpectPresenting documentation in a timely manner will expedite the inspection process and provide a positive impression to agency representatives.
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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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Salary Survey: Is Your Paycheck as Robust as Your Proteins?The biotechnology industry is thriving, and hopefully you are too. BioPharm International's first salary and employee satisfaction survey presents a wealth of data that will allow you to compare many aspects of your job with those of your peers. The survey reports on demographics, education, work experience, salary and benefits, and attitudes toward current employment.
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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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Immunogenicity of Biopharmaceuticals: An Example from ErythropoietinSubcutaneous administration is likely to be an important factor in generating an immunogenic response.
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Effective Biopharmaceutical Quality Assurance UnitsQuality assurance units are interwoven throughout the biopharmaceutical enterprise and provide support to sustain operations. Most importantly, they must have the capacity and leadership to adapt to change.
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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.
