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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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Advances in mAb Purification with Super A Chromatography ResinWebinar Date/Time: Thurs, September 19, 2024 Session 1: 9:00am EDT | 1:00pm GMT | 2:00pm CET Session 2: 1:00pm EDT| 5:00pm GMT | 6:00 am CET
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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.
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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.
