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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.
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Final Word: The Public Side of Science: The Cloning Three Ring CircusIn this century, we are unlikely to face biomedical issues more complex and controversial than that of human cloning coupled with embryonic stem cell research. With the stakes so high — promises of cures and therapies for a host of devastating diseases and medical conditions set against impassioned disputes about when life begins — the cloning debate has evolved beyond the realm of scientific discourse and into the spotlight of public opinion. Unfortunately, this intense scrutiny, largely fueled by the media, has resulted in the misrepresentation of facts, and the twisting of scientific opinions as statements about cloning are often taken out of their appropriate context. In an attempt to counteract this damaging trend, The Science Advisory Board decided to poll its members about some of the most controversial aspects of the cloning debate.
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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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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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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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Final Word: Think Safety and Use Common Sense to Meet New IND GMP RegulationsOn January 17, 2006, the FDA released new regulations, effective June 1, 2006, which affect the production of most investigational drug and biologic products intended for phase 1 clinical trials. These regulations are much broader in scope than the Exploratory IND guidance released on the same day, and which apply only to low-risk, CDER-regulated clinical studies.
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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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Enhanced Packaging and Reformulations Give New Life to BiologicsFormulations for pulmonary inhalation comprise spherical, porous particles that are 1–3 microns in diameter.
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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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Filtration Designs Remove Processing Bottlenecks for High-Yield Biotech DrugsBiotech companies are running into production bottlenecks because standard purification and separation technologies lack the capability to remove the elevated levels of biomass from high titer solutions. Recent developments in filter technology offer the biotech industry a cost-effective solution to processing challenges by reducing bottlenecks, thereby accelerating the time-to-market of new drugs.
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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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Filter Clogging Issues in Sterile FiltrationA case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.
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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.
