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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.
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Facility Design and Expansion: Commissioning for InnovationOnce guiding principles are identified, designers can explore the most cost-effective methods for delivering a flexible, expandable site.
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A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 3: Effects of Manufacturing Changes in Immunogenicity and the Utility of Animal Immunogenicity StudiesManufacturing changes - such as changes in formulation or source material - can impact a product’s immunogenicity.
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Automated Process Control for the Development LaboratoryMinimum disruption and maximum gain result when adopting a distributed process control and data management system for a cell culture and fermentation lab.
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The United Kingdom: Leading the Global Competition for BiotechAs a company that performs site selection for biopharmaceutical companies worldwide, Fluor Global Location Strategies has witnessed one country truly distinguishing itself from the competition as a worldwide leader in the industry: the United Kingdom. The global competition for biotech investments has been at a fever pitch over the past few years, with varied results.
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Securing Your Company's Manufacturing DataA 2000 cyber crime study revealed that 71 percent of security breaches were caused by people who worked within the company.
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Gas Selection/Management for the Biotech LabSimple practices can increase profit margins and ensure gas supply.
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Expediting the Technical Transfer of Biopharmaceutical ProductsEstablished, fully validated methodology and SOPs are required prior to initiation of any training activities.
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Specification Setting: Setting Acceptance Criteria from Statistics of the DataThis article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.
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Information Management Systems Enable Manufacturing Facilities to Ramp Up ProductivityPharma industry equipment utilization hovers below 40 percent, which would be an unacceptable figure in most industries.
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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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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.
