Authors
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White paper: Effects of X-ray Inspection of Pharmaceutical ProductsThis paper answers a major concern of manufacturers: Do x-rays affect the quality and efficacy of a drug during product inspection?
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Managing Risk for Biomanufacturing Raw MaterialsUSP is developing new guidelines to help organizations prioritize risk and ensure raw material quality.
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USP Publishes Monoclonal Antibody GuidelinesA General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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EMA Guideline on Setting Health-Based Exposure LimitsThe results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Removing Aggregates from Monoclonal AntibodiesSeveral chromatographic resins are available for downstream purification.
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Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time ImagingThe pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.
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Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time ImagingThe pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.
Latest:
Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time ImagingThe pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.
Latest:
Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time ImagingThe pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.
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Managing Staff Training And GMP ComplianceA case study describes how a software control system can manage training needs across an international company and improve GMP compliance.
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Choosing Personal Protective Equipment for Handling Cytotoxic DrugsCompanies manufacturing cytotoxic drugs must ensure that staff are given the highest possible levels of protection.
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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk AssessmentIn-silico design facilitates process optimization and evaluation of process control strategies.
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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk AssessmentIn-silico design facilitates process optimization and evaluation of process control strategies.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk AssessmentIn-silico design facilitates process optimization and evaluation of process control strategies.
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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk AssessmentIn-silico design facilitates process optimization and evaluation of process control strategies.
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Navigating the Complexities of Emerging Therapy DevelopmentAdvancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.
