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CMOs Leading the Way on Single-Use Systems AdoptionSingle-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
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Characterizing Biotherapeutics and Determining Biosimilar ComparabilityThe ability of SPR-based analysis to estimate association and dissociation rate constants is a major advantage over the traditional steady-state analysis of biomolecules.
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Pharmaceutical Compounding Calculations, Part One–Non-Salts, Salts, and Policy-Exception SaltsCalculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.
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Utilizing Spectral Analysis in HPLC Diode Array to Discover ImpuritiesInvestigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.
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Quantification and Characterization of Polysorbate-80 in Protein FormulationsHPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.
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FDA Modernizes Controlled Correspondence Interactions with Pharma IndustryAs part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
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FDA Modernizes Controlled Correspondence Interactions with Pharma IndustryAs part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
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Direct Compression Versus GranulationCompressed tablets are the most widely used solid dosage form so they must satisfy a number of physical requirements in terms of hardness, disintegration ability, friability and uniformity.
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Improving Process Mass Intensity for Bio/Pharmaceutical ProductionProcess optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Assuring the Safe Handling of Potent APIs, Intermediates, and Solid-Dosage DrugsContainment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.
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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.
