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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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Economy and Reproducibility: Varying Virus Spike Conditions on a Planova 20N Virus-Removal FilterIntroduction; Materials and Methods
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Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
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The CMO Advantage in Biologics ManufacturingBiologics manufacturing is a technologically complex, highly regulated process. In comparison to small-molecule manufacturing, biologics manufacturing requires far more planning, investment, and skilled personnel and, therefore, can be much riskier. For biotech companies requiring such manufacturing capabilities and experience, partnering with a biologics-focused contract manufacturing organization (CMO) can be a good solution.
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Rapid Development and Optimization of Cell Culture MediaChinese hamster ovary (CHO) cells are used extensively in the biopharmaceutical industry to produce recombinant proteins that require post-translation modification for full biological functionality. Optimization of culture conditions for recombinant CHO cell lines presents challenges in light of the diverse nutritional requirements observed with different clonally derived cell lines.
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Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their ContractorsDuring the past several years in the pharmaceutical and biopharmaceutical industries, conflicts and misunderstandings have arisen between companies and their contractors. Too often, productive working relationships have crumbled, resulting in expensive production delays with companies and contractors squabbling over their roles and responsibilities. Such conflicts may have their roots in the lack of a sound quality agreement (QAG). QAGs that clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor can help companies and their contractors avoid certain conflicts.
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On-Demand GMP CMO Capacity through Sequential Cascade BioManufacturingIntroduction, Capabilities
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Successful Steps for Outsourcing the Manufacture of Clinical Trials MaterialsConsider the number of patients, the dose each will receive (and how this dose is calculated), the number of doses per patient, and what overage is needed to allow for vial breakage.
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Rapid Development and Optimization of Cell Culture MediaChinese hamster ovary (CHO) cells are used extensively in the biopharmaceutical industry to produce recombinant proteins that require post-translation modification for full biological functionality. Optimization of culture conditions for recombinant CHO cell lines presents challenges in light of the diverse nutritional requirements observed with different clonally derived cell lines.
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Filtration:Vendor Notes: The Effect of Flux Decay on a 20-nm Nanofilter for Virus RetentionAlthough contaminants and other parameters may be main causes of filter breakdown, some nanofilters still remove viruses at high Log Reduction Value (LRV).
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China Today: Vaccine Development in ChinaThe Chinese vaccine market competition is now transferring from the former price-competition model to a technology- competition model.
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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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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.
