Authors
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Match.Contractmanufacturing: Finding The Perfect MatchThe contract manufacturer must have sufficient capacity so it can absorb possible surge in demand, and back-up capability in case of a power failure or other event.
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The Company at the Crossroads. Part 2: Build or Buy?When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.
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Single-Use Technologies—A Contract Biomanufacturer's PerspectiveOne of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors.
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Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 2The second of a two part article.
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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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A Rapid Solution to the Challenge of Synthetic Peptide PurificationA new universal RP-HPLC column for peptide purification, and the use of novel flow-through media for the removal of acidic ion pairing agents and peptide free base formation are reported. The use of these two products, with SOPs, can substantially increase the throughput of peptide manufacture.
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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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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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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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Validation & Compliance: Using Risk Analysis in Process ValidationAll of the primary unit operations for cell culture and purification had scores greater than the action threshold.
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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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Platform Technology for Developing Purification ProcessesThe future of therapeutic MAbs lies in the development of economically feasible downstream processes.
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Sterile Fill Facilities: Problems and ResolutionsThe author shares a case example that applies an eight-step structured approach to the front-end engineering of a vaccine R&D fill-and-finish facility project. Assumptions, issues, action items, owner interface, and interdisciplinary coordination are covered to meet the challenges of timing, technology, compliance, and cost.
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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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Single-Use Technologies—A Contract Biomanufacturer's PerspectiveOne of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors.
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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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Biopharmaceutical Manufacturing Using Blow–Fill–Seal TechnologyThe authors give special consideration factors affecting blow–fill–seal technology.
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IP Briefs: Demystifying the Patent Reform Act and its Impact on Company IP StrategyThe Act will establish third party rights to challenge the validity of a patent through postgrant opposition proceedings.
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Upstream Processing:Vendor Notes: Generating Stable, High-Expressing Cell Lines for Recombinant Protein ManufactureManufacturing recombinant proteins at industrially relevant levels requires technologies that can engineer stable, high-expressing cell lines rapidly, reproducibly, and with relative ease. Commonly used methods incorporate transfection of mammalian cell lines with plasmid DNA containing the gene of interest. Identifying stable, high-expressing transfectants is normally laborious and time consuming. To improve this process, the ACE System has been developed based on pre-engineered artificial chromosomes with multiple recombination acceptor sites. This system allows targeted integration of single or multiple gene copies and eliminates the need for random integration into native host chromosomes. To illustrate the usefulness of the ACE System in generating stable, high-expressing cell lines, we present several case studies covering CHO cell lines expressing monoclonal antibodies.
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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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Upstream Processing:Vendor Notes: Generating Stable, High-Expressing Cell Lines for Recombinant Protein ManufactureManufacturing recombinant proteins at industrially relevant levels requires technologies that can engineer stable, high-expressing cell lines rapidly, reproducibly, and with relative ease. Commonly used methods incorporate transfection of mammalian cell lines with plasmid DNA containing the gene of interest. Identifying stable, high-expressing transfectants is normally laborious and time consuming. To improve this process, the ACE System has been developed based on pre-engineered artificial chromosomes with multiple recombination acceptor sites. This system allows targeted integration of single or multiple gene copies and eliminates the need for random integration into native host chromosomes. To illustrate the usefulness of the ACE System in generating stable, high-expressing cell lines, we present several case studies covering CHO cell lines expressing monoclonal antibodies.
Latest:
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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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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Elements of Quality by Design in Development and Scale-Up of Freeze-Dried ParenteralsDesign space concepts are key to a successful technology transfer.
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Providing a Comprehensive Range of Biopharmaceutical Process Development and cGMP Manufacturing ServicesCytovance Biologics is a contract biopharmaceutical process development and cGMP manufacturing organization specializing in products derived from mammalian cell culture. Our highly experienced team of experts is committed to providing best-in-class services that help our customers move recombinant protein and antibody products rapidly and cost-effectively into and through clinical development. We employ a collaborative and flexible approach and business practices that meet the long-term needs of our customers and deliver long-term value and support.
