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Latest:
Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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Evaluation of AAV Aggregation & Capsid Load (Empty / Full) CQAs Using Novel 700 Å SEC ColumnWebinar Date/Time: Wed, Sep 4, 2024 11:00 AM EDT
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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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Leveraging Fermentation Heat Transfer Data to Better Understand Metabolic ActivityA simple method to leverage fermentation heat transfer data.
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Final Word: Beware of Patent Infringement During Discovery ResearchExperimenting with a rival?s patented compound may land you in hot water.
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Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
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Purification of IgM Monoclonal AntibodiesManufacturing challenges surround the use of IgM monoclonal antibodies, but these can be overcome with current technology.
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Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
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Formulation Studies of an Adsorbed Conjugate VaccineNeisVac-C is a polysaccharide-protein conjugate vaccine for use against Neisseria meningitidis serogroup C infection. The Phase 1 clinical formulation consisted of physiological saline, thimerosal, and aluminum hydroxide. The long-term stability data for both the PBS and saline formulations are presented in this article.
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Biopharma Contract Manufacturing Prices Go Up—and DownA dynamic market, industry consolidation, and demand fluctuations lead to a mixed picture of pricing results.
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Purification Strategies to Process 5 g/L Titers of Monoclonal AntibodiesAltering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.
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Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit OperationA review of some recent contributions in process chromatography.
Latest:
Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
Latest:
Purification of IgM Monoclonal AntibodiesManufacturing challenges surround the use of IgM monoclonal antibodies, but these can be overcome with current technology.
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Tanks for the MemoriesSingle-use systems have greatly improved and simplified common manufacturing issues.
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Royalty Interest Investing: Addressing the Out-License Assignability IssueSeveral legal considerations are key to protect the buyer and seller in royalty interest transactions.
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Detection of Cache Valley Virus in Biologics Manufactured in CHO CellsAvoid manufacturing failures by effective viral inactivation.
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Trends in Convertible Note Financing for BiotechsAs more biotechs turn to convertible note financing instead of traditional venture capital, they need to be aware of investors' demands.
Latest:
Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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QbD: Convincing the SkepticsWithout a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.
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Standardized, Hands-on Biomanufacturing Training is EssentialThe development of a skilled labor force is essential for an expanding biopharmaceutical industry.
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Strategies for Sourcing Animal-Origin Free Cell Culture Media ComponentsHow to successfully balance patient safety with supply-chain management
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Detection of Cache Valley Virus in Biologics Manufactured in CHO CellsAvoid manufacturing failures by effective viral inactivation.
Latest:
Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
Latest:
Purification of IgM Monoclonal AntibodiesManufacturing challenges surround the use of IgM monoclonal antibodies, but these can be overcome with current technology.
Latest:
The Development and Application of a Monoclonal Antibody Purification PlatformA purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
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Coming to a Biotech Near You: Quality by Design Part 2: Design Space in Development and ManufacturingQuality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.
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A Purification Platform for the Production of MAbs from Fermenters with Titers of 5 g/L and BeyondNew techniques can overcome bottlenecks in existing facilities.
