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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.
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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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Final Word: How to Attract Venture Capital – SuccessfullySuccessful acquisition of funding from venture capital (VC) partnerships requires a carefully planned, well-executed marketing campaign. You are, after all, selling ownership interests in your company when you seek VC investors. This sale requires an attractive product, nicely packaged, and presented in a way that allows the potential customer to understand and appreciate its value. The attractiveness of your company is the sum of many factors including revenue potential, intellectual property estate, time-to-milestones, existing competition, ease of entry, quality of management, and the perceived interest in your work by "the big guys" in your sector. Every potential venture investor will not perceive your company the same way.
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The Heart of Ireland's Economic Development StrategyThe Irish Minister for Enterprise, Trade, and Employment supports and encourages biotech research and development.
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Rapid Microbiological Methods and the PAT InitiativePAT can be defined as a collection of real-time data in-line to make decisions about product quality early in the production process.
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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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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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State-of-the-Art vs. Tried and TrustedFactors such as quality, time to market, and regulatory changes are forcing an evolution to state-of-the-art analytical test methods.
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Aseptic Processing for Cytotherapy, Regenerative Medicine, and Tissue-Engineered ProductsIsolators offer a safety and economic advantage for next-generation regenerative medicine products.
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Biopharmaceutical Characterization Techniques for Early Phase Development of ProteinsCharacterization of biopharmaceuticals (proteins) during early development is done for several reasons. The most important reason is the need to have supporting data that demonstrates the comparability of material used throughout development. This is particularly important as the production process is optimized and small changes in the process may affect the structure of the product. Demonstration of comparability of proteins produced throughout product development is more complicated, due to the inherently heterogeneous nature of many biologicals.
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PEGylation of Proteins: A Structural ApproachThe type of reactive moiety controls the site and stability of the covalent link and also the total number of PEGylation sites on a given protein.
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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.
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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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Biopartnering: Keys to SuccessThe pharmaceutical and biotechnology industries are at a critical point in their evolution. Industry experts at Datamonitor, an independent market analyst firm, say that in 2002 about $30 billion worth of blockbuster drugs lost patent protection. By 2008, an additional $35.5 billion worth of products is expected come off patent. At the same time, a host of scientific innovations in drug discovery including the use of high-throughput screening techniques, new classes of therapeutics such as aptamer technology and RNAi, and genomics-driven discovery methods, have resulted in large numbers of new drug candidates.
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New Binary Gas Integrity Test Improves Membrane Quality AssuranceThe authors developed a test for defects in filter membranes.
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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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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.
