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The Link Between Manufacturing and Commercialization in Gene and Cell TherapiesThe highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
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Secure Critical Life Science AssetsWhen life science facilities are forced to shut down, or operate with fewer staff, it exposes a severe lack of capabilities to monitor critical assets and environments. This white paper states critical parameters in a lab or life science facility that should be monitored by a 24/7 real-time data acquisition system.
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The Link Between Manufacturing and Commercialization in Gene and Cell TherapiesThe highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
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Approaches to Reduced Sampling and Testing for Starting MaterialsThis article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.
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Managing Clinical Development Risk: Pharma and CRO ReportThe relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.
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Solving Sticking and Picking Through Tablet DesignSticking and picking are common problems in tablet manufacturing. Considering tablet compression issues before tablet designs are finalized can prevent unanticipated problems during scale-up and full-scale production.
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Solving Sticking and Picking Through Tablet DesignSticking and picking are common problems in tablet manufacturing. Considering tablet compression issues before tablet designs are finalized can prevent unanticipated problems during scale-up and full-scale production.
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Advanced Cell Penetrating Peptide Systems for Gene TherapyIntracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.
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Advanced Cell Penetrating Peptide Systems for Gene TherapyIntracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.
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Advanced Cell Penetrating Peptide Systems for Gene TherapyIntracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.
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Leveraging Computational Models of Glycosylation for Biopharma QAClose collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
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Degradation Pathways: A Case Study with Pegylated L-AsparaginaseIt is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
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Degradation Pathways: A Case Study with Pegylated L-AsparaginaseIt is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
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Gilding the PillMarket demand and regulatory guidance continues to promote improved medication design.
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Technology Transfer: Best Practices in Operational DevelopmentSuccessful technology transfer depends on the ability to anticipate risks and plan ahead.
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Technology Transfer: Best Practices in Operational DevelopmentSuccessful technology transfer depends on the ability to anticipate risks and plan ahead.
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Layer by Layer: The Fundamentals of Multi-Layer Tableting***Live: Tuesday, Oct. 27, 2020 *** Multi-layer tableting offers an inexpensive and straightforward solution for a variety of challenging formulations. Learn how multi-layer formulations compare to traditional methods, gain insight to the multi-layer tableting process, and crucial tips to formulating and manufacturing robust multi-layer tablets. ***On demand available after final airing until Oct. 27, 2021***
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Speeding Sample Preparation and API Extraction from Solid Oral Dosage FormulationsLaboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.
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Speeding Sample Preparation and API Extraction from Solid Oral Dosage FormulationsLaboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.
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Speeding Sample Preparation and API Extraction from Solid Oral Dosage FormulationsLaboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.
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Speeding Sample Preparation and API Extraction from Solid Oral Dosage FormulationsLaboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.
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Modified-Release Formulations: Improving Efficacy and Patient ComplianceModified-release oral dosage forms can offer benefits to both formulation scientists and patients.
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Modified-Release Formulations: Improving Efficacy and Patient ComplianceModified-release oral dosage forms can offer benefits to both formulation scientists and patients.
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Digitizing to Modernize ManufacturingMoving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.
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Improving Pharma Supply Chain Agility: A Lesson from the Retail IndustryNovartis, BMS, and other companies are reducing complexity by thinning out product portfolios. Reducing complexity can reduce waste and improve responsiveness, but it must be done right.
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Details Make the Difference for Successful Disinfection v2Many details must be considered to maintain a successful disinfection program. These details can make a big difference in a critical environment.
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Role of Particle Morphology on Tablet Dissolution RatesParticle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.
