Authors
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Controlled Crystallization During Freeze-DryingThe authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
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Deviation Investigation Format and Content: A Guide for Inspection SuccessThis article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
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Countering the Loss in Efficiency Caused by Mandated Serialization Complianceigital tracking of overall equipment effectiveness can improve efficiency.
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Chemspec Europe 2022 35th International Exhibition for Fine and Speciality ChemicalsChemspec Europe is the fine and speciality chemicals exhibition held in Frankfurt, Germany, providing a powerful industry platform for product sourcing, networking opportunity and knowledge transfer via a comprehensive conference programme.
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Cleaning Chromatography Resin Residues from SurfacesLaboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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Navigate your Efficient-Pro journey with professional supportThis asset outlines the comprehensive support and guidance offered by the FAS team for optimizing monoclonal antibody (mAb) manufacturing processes using the Efficient-Pro medium and feeds. Readers will learn about the tailored assistance provided at every stage, including troubleshooting, recommendations
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Solid-Phase Extraction for the Preparation of Aqueous Sample Matrices for Gas Chromatographic Analysis in Extractable/Leachable StudiesSolid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
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Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
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Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Latest:
Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Latest:
Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
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CROMAIMA is world leader in the design and manufacture of automatic machines and complete lines for the processing and packaging of pharmaceutical products.
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iMScope TRIOLatest:
Transforming Regulatory Data ManagementThe Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
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Addressing Security Risks in Connected OperationsA rigorous approach to industrial security is essential for protecting intellectual property and product integrity in connected pharmaceutical operations.
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Testing Water for Pharmaceutical UseUSP describes analytical and microbiology testing required for different types of pharmaceutical water.
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Innovation Boom TownsPartnerships between industry and academic medical centers are expanding to meet R&D needs.
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Understanding Fluidized-Bed GranulationThis study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
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Ensuring the Continuous Supply of Quality Drug Products During Uncertain TimesThe global coronavirus pandemic has tested the abilities of bio/pharmaceutical companies to develop new therapies and maintain-or even accelerate-production of existing drugs. In this webcast, experts will discuss business continuity practices, regulatory compliance, and supply chain management under current-or future-emergency conditions. Live: Tuesday, Apr. 28, 2020 at 11 am EDT | 10 am CDT | 8 am PDT On Demand: available after airing until Apr. 28, 2021 Register free
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Clean, Disinfect, and ValidateEffective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.
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Cold Chain Logistics for Personalized Medicine: Dealing With ComplexityThe complex packaging and logistics required for personalized medicine pose significant challenges, but proactive planning can help ensure success.
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Continuous Manufacturing: A Generic Industry PerspectiveThe pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
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Decoding Serialization RegulationsThe author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.
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Particle Size Reduction for Investigational New DrugsModern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.
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A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic SolutionIn this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic SolutionIn this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic SolutionIn this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
