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FDA's Recommendations to Industry Regarding OutsourcingOutsourcing introduces considerable complexity into ensuring compliance with good manufacturing practices. This article offers FDA guidance for how to ensure compliance in the outsourcing environment.
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Versatility of a Single-Use Bioreactor Platform for Culture of Diverse Cell TypesAre disposable bioreactors effective for cell culture?
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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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Filter Clogging Issues in Sterile FiltrationA case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.
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Developing and Manufacturing Attenuated Live Bacterial VaccinesThere are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines.
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NIH Offers Licensing Agreements to Commercialize TechnologiesNIH makes available a full range of licenses for commercial evaluation and for the sale of commercial products and services.
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Developing and Manufacturing Attenuated Live Bacterial VaccinesThere are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines.
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Biopharmaceuticals in India: Evolving from Generics to Innovator DrugsThe new patent regime is challenging the Indian biopharm industry to transition from generics to novel products.
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Implications of Cell Culture Conditions on Protein GlycosylationThe authors present a review of the techniques commonly used for glycosylation analysis.
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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.
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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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Connecting the Manufacturing Process to Patient WellnessManufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.
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Vaccines Incorporating Toll-Like Receptor LigandsThis article discusses the production process of the major influenza antigen, hemagglutinin (HA), by rDNA methods in E. coli.
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Upcoming Technologies to Facilitate More Efficient Biologics ManufacturingChoosing the right tools to enhance the process.
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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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Integrating Risk Management as an Effective Approach to Root Cause AnalysisOptimize time and cost of product development by managing risk.
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Meningitis Vaccine Manufacturing: Fermentation Harvest Procedures Affect PurificationCareful analysis of an unusual precipitate identifies defects.
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Upgrading a Pharmaceutical Laboratory to Part 11 ComplianceFDA's regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper records and handwritten signatures.1
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Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit OperationA review of some recent contributions in process chromatography.
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Devising an International Clinical Trial Distribution Strategy: Genentech's ApproachA decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term.
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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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Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
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Failure Mode Effects Analysis for Filter Integrity TestingUnderstanding of the risks associated with FMEA is crucial in lot release testing.
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The Therapeutic Vaccine Potential of MIS416 AdjuvantThis article discusses the potential of MIS416 adjuvant, a vaccine adjuvant and immunogen co-delivery system, to provide adequate immunostimulation to overcome host factors that may limit the success of therapeutic vaccines.
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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?
