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Disposable Process for cGMP Manufacture of Plasmid DNADisposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation.
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Feature-Rich, Integrated Quality, and Regulatory Compliance Management Software for Biopharmaceutical CompaniesAbstract: Sparta Systems' TrackWise quality and compliance management software (QMS) helps global biopharmaceutical companies reduce risk, achieve compliance, and lower costs. TrackWise streamlines processes by improving visibility, traceability, and accountability through structured workflow, escalation and reporting.
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Antibody Purification with an Integrated Disposable AssemblyComparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high.
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Virus Clearance Strategy Using a Three-Tier Orthogonal Technology PlatformHow to implement a risk-based approach to eliminate viruses using orthogonal technologies.
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A Case Study of Developing Analytical MethodsContract manufacturers must plan for increased analytical resources in development and quality control.
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The Company at the Crossroads. Part 1: To Commercialize or Not?Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.
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The Importance of Project ManagementAre the deadlines for your outsourced projects often not met? Are you unsure of the status of your project at any given time? Is the original budget of your study typically exceeded?
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Biopharmaceuticals Approval Trends in 2013A review of the past year's trends in biopharmaceutical approvals shows an above average approval rate.
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Platform Technology for Developing Purification ProcessesThe future of therapeutic MAbs lies in the development of economically feasible downstream processes.
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Demonstrating Comparability of Stability Profiles Using Statistical Equivalence TestingThe authors present an approach for testing statistical equivalence of two stability profiles.
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The Evolution of Protein Expression and Cell CultureIt is commonly believed that technologies in the next 10–15 years will enable sequencing an individualized human genome for less than $1,000. With innovations like these, the twenty-first century will certainly belong to biotechnology. From an industrial standpoint, the discovery of therapeutic molecules and the development of cell lines and processes to produce these molecules will be of paramount importance. This article describes various approaches that have been prevalent in the industry or are likely to be used in the future for generating cell lines with desirable traits and developing high titer cell culture processes.
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Cell-Culture–Based Manufacturing: Meeting the Challenge of 21st Century InfluenzaVaccines against strains originating from avian flu may achieve poor yields in egg-based systems. Consequently, both public and private interest in alternative systems is high.
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Chromatography: A Two-Column Process To Purify Antibodies Without Protein AThis flexible setup minimizes the number of purification process steps, buffers, and process components.
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The Impact of Expedited Review Status on Biomanufacturing Facility DesignFor rapid scale-up of biomanufacturing under expedited review status, facility design must better integrate product development and manufacturing lifecycle activities.
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Pandemic Flu Preparedness: A Manufacturing PerspectiveFor pandemic vaccine processing, single-use filter cartridges and membrane chromatography technologies could offer significant time- and cost-reduction advantages.
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New-Age Vaccine Adjuvants: Friend or Foe?Adjuvant-caused vaccine reactions are one of the most important barriers to better acceptance of routine prophylactic vaccination.
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Quality by Design in the CMO EnvironmentHow the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.
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Downstream Processing: Improving Productivity in Downstream ProcessingIncreased resin stability can extend the number of cleaning cycles that can be performed in situ.
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Strategies to Improve Vaccines for the NeonatePotential interference with maternally-derived antibodies makes most vaccines less effective in the neonate.
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The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional VaccinesIn animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.
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Rapid High-Throughput Feed OptimizationGrowth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.
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An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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Increasing Capacity Utilization in Protein A ChromatographyA twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.
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DNA Vaccine DeliveryDevelopment of the ideal DNA vaccine requires the optimization of delivery strategies and plasmid vectors.
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Chromatography: A Two-Column Process To Purify Antibodies Without Protein AThis flexible setup minimizes the number of purification process steps, buffers, and process components.
Latest:
The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional VaccinesIn animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.
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ON-LINE PROCESS CONTROL: Automating the Control of Process-Scale Purification Columns Using On-Line Liquid ChromatographyThis article discusses how on-line high-performance liquid chromatography (HPLC) can measure product purity in the column eluent stream in near–real time. These data can then enable the automation and control of a purification column operation, thus reducing product variability, shortening process cycle time, and increasing yield. An example application demonstrates how on-line HPLC is used as a process analytical technology to ensure the process can accommodate variability in the separation while ensuring the product meets its critical quality attributes.
