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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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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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How Small Biotechs Should Protect Their Interests During Mergers and AcquisitionsStrategic alliances and partnering deals were a big biotech news story during 2006-with deal values setting an all time record of over $23 billion for the year. The strategic partnering trend continues during 2007 and in this column we present some frequently asked questions and answers about the merger and acquisition (M&A) activity in the life sciences sector.
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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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Virus Removal by Filtration: Points to ConsiderIt is important to ensure that flow decay during processing is comparable to that observed during retention studies.
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QRM Tools for Contract BiomanufacturingQuality-risk management tools can assist biopharma companies in mitigating risks when outsourcing crucial elements of the drug-development process.
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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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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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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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Upgrading a Pharmaceutical Laboratory to Part 11 ComplianceFDA's regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper records and handwritten signatures.1
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Final Word: Canada's Landmark Decision: Planting the SeedCommercial embodiments of genetically modified inventions are protected in Canada.
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Validation Outsourcing: Getting the Most Out of Your Client?Contractor RelationshipSupplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.
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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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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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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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Introduction: An Overview of Intellectual PropertyBiopharmaceutical companies need to consider intellectual property issues early on, even at the start-up stage.
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From The Publisher Why Ireland?As companies evolve, they often must select new locations where they can centralize or expand their operations. This can be a daunting challenge that demands consideration of numerous factors.
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Intellectual Property LitigationPatents are litigated in the biopharmaceutical industry perhaps more often than any other form of IP
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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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Bioprocessing Technology Trends of RNA-Based Therapeutics and VaccinesThe authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.
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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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Downstream Process Optimization Opportunities Using On-Line and At-Line PAT InstrumentationThe purpose of the PAT initiative is to move analytical laboratory functions close to the manufacturing process to improve manufacturing efficiency and product quality.
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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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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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Successful Technology Transfer Requires More Than Technical Know-HowWe often assume we know what success looks like for our partner, but we never ask them, or take the time to write it down.
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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.
