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Final Word: The National Academies' Guidelines for Human Embryonic Stem-Cell ResearchOn April 26 the National Academies of Sciences and the Institute of Medicine released guidelines for human embryonic stem (hES) cell research, the result of eight months of deliberations by a human research ethics committee I co-chaired with MIT's Richard O. Hynes. Composed of scientists, physicians, lawyers, ethicists, a social scientist, and a private citizen, the committee held a two-day public workshop and numerous meetings. We also reviewed international guidelines, policies, and procedures in this field.
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Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
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International Patents and International Harmonization...biopharmaceutical companies still face rampant piracy and counterfeiting of patented products.
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The Value of a Supplier AllianceThese latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to the need to create smarter manufacturing operations
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Cell Line Authentication Using Isoenzyme AnalysisStrategies for accurate speciation and case studies for the detection of cell line cross-contamination using a commercial kit.
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Biosafety for Large-scale Operations Using Recombinant DNA TechnologyCurrent best practices of containment reduce the risks associated with biotech development.
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Chinese Biopharm Investment Moves Rapidly Up the Value ChainChina is becoming a much more sophisticated economy, with a large and well-educated workforce.
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The Laboratory Control System: Fulfilling cGMP RequirementsReserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.
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By the Numbers: What it Costs to Operate a Biopharmaceutical FacilityOperating costs are the white-hot issue in the boardrooms of our life sciences clients and they tend to rule the site selection process. A soft economy, worldwide trade competition, drug cost containment pressures from the US government, and a lean and mean message sent by the venture capital community mean that quantitative factors that focus on the cost of doing business are trumping qualitative lifestyle factors, especially when evaluating sites for a new biopharmaceutical facility.
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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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A Systems-Based Team Approach to GMP ComplianceCompanies faced with real or threatened FDA sanctions are usually least prepared to react effectively.
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A Case Study for the Inactivation of TSE Agents: Using an Alkaline Treatment in the Manufacturing Process of a Cell Culture Media SupplementBiopharmaceuticals are perceived as being at risk of transmitting spongiform encephalopathies to patients, although there has never been such an incident. Clearance studies such as the one described in this article (using a TSE model) can validate inactivation and enhance confidence in the safety of therapeutics produced using animal-derived cell culture supplements.
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Site Expansion: Adaptive Reuse of FacilitiesConversion of facilities from one use to another is a positive trend that keeps good paying jobs in local communities.
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Best Practices in Demand and Inventory PlanningThe foundation of a sound supply chain planning infrastructure requires implementing a strong, systematic forecasting process.
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Final Word: Obtaining Government Funding in a Post 9/11/EraThe ripple effects of 9/11 are still being felt, creating changes among individuals, businesses, and government organizations. The biotech community is no different; companies are taking a new look at the way they do business and shifting their focuses in response to new opportunities presented by federal preparedness programs. In 2004, President Bush signed "Project BioShield," a bill that made $5.6 billion in federal funds available over a 10-year period to develop countermeasures against chemical, biological, radiological, or nuclear attack. An additional $2.5 billion was added to the initiative in 2005. Numerous grants and contracts have already been awarded to companies developing innovative prophylactic measures, treatments, and diagnostic tools to be used in the event of a biological attack.
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Achieving Global Consensus through the International Conference on HarmonizationThe concept of design space has started a minor revolution in our industry.
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International Patents and International Harmonization...biopharmaceutical companies still face rampant piracy and counterfeiting of patented products.
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Centralizing Compliance for Competitive AdvantageAs the bustle of Sarbanes-Oxley (SOX) 2004 compliance deadlines for companies winds down, executives have an opportunity to reconsider their company's compliance strategy.
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State Regulation of Clinical TrialsFor those conducting clinical trials, strict adherence to state regulatory requirements makes sound business sense.
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Final Word: Clinical Research Organizations Make a DifferenceAchieving approval of a new pharmacologic agent or device on a worldwide basis is a significant challenge. The guidelines and requirements that steer our efforts at enhancing and extending life around the world are tedious and, fortunately, comprehensive. In spite of relatively few setbacks, perhaps in no other category than pharmaceutical development are the advantages of these guidelines more evident.
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The CRO Advantage: Outsource Clinical Trials to Launch Biotech Development SuccessLess than 35 percent of all biotech companies have sufficient finances to survive beyond one year.
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Final Word: Regulatory EvolutionHow much do regulatory agencies know about nanotechnology or microfluidics? Yesterday, the answer was probably, "not much." Tomorrow, it may be "a lot." The reason is that new technologies push the agencies to expand their expertise.
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IP Briefs: The Positive Side of Negative DisclaimersAddition of a disclaimer to a claim, based on words not present in the application as filed, is referred to as an undisclosed disclaimer.
