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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.
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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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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.
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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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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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Continued Process Verification and the Drive to Digitize the Process Validation LifecycleManaging data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.
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Continuous Chromatographic mAb Polishing via Step Gradient SMBWebinar Date/Time: Tue, Dec 3, 2024 Session 1: 9:00 am EST | 1:00pm GMT | 2:00pm CST Session 2: 2:00 pm EST| 1:00pm CST| 11am PST
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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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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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cGMP Custom Manufacturing of Tomorrow's MedicinesCobra Biomanufacturing is dedicated to designing robust processes that deliver high-quality preclinical and clinical biopharmaceutical products for its international life-sciences customers. From proteins and viruses to DNA and cells, Cobra offers a full range of biomanufacturing services and has established an enviable track record in cGMP manufacturing.
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Utilizing RFID Technology to Make Filtration Processes Easier, More Reliable, and FasterRadio frequency identification (RFID) technology is a reliable, accurate method of conveying critical information from point to point. Well established digital data transfer standards ensure complete and accurate exchange of critical data at almost instantaneous speeds. Unlike bar codes, RFID possesses larger data storage capability meaning more information is available. RFID tags are embedded in the filters which make the data available at point of use, where you need it, and inherently less susceptible to mechanical damage. Finally, RFID does not require a specific orientation to be read, eliminating the need for human intervention, thus lending itself to reliable automated processes.
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Vendor Notes: The Biovest AutovaxID: Enabling the Promise of Personalized MedicineThe AutovaxID is a self-contained, completely enclosed, fully automated hollow fiber bioreactor that permits rapid, efficient scale up of patient-derived cells. It is based on hollow fiber bioreactor technology and is an ideal system for high-density cell culture and the production of monoclonal antibodies or other therapeutic proteins.
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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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Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 2The second of a two part article.
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Outsourcing: What is the Path Forward?The greatest benefits of outsourcing are realized when a company takes a strategic approach rather than a tactical approach.
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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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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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Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 2The second of a two part article.
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Biotech Manufacturing Grows UpIt became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable.
