Authors
Latest:
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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Careful, Early Cold-Chain Planning is Crucial for New BiologicsCold-chain requirements and the tight logistical windows needed for cell and gene therapies demand a focus on early communication and risk mitigation.
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Serialization: The Final CountdownMany pharmaceutical manufacturers were late in involving contract partners in serialization efforts. Are you ready, and are you working with the right partner?
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Serialization Preparation Prompts Data and Business QuestionsAs the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.
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Monitoring Supply Chain Risk on a Limited BudgetMonitoring supply-chain risk involves more than running a credit check on potential suppliers. It can, however, done without external expense.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Evaluating E&L Studies for Single-Use SystemsExtraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Collaborating for Efficiency and Safety in Raw Material InspectionBy working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.
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Collaborating for Efficiency and Safety in Raw Material InspectionBy working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.
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CDMOs: New Administration, New FrontierDespite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Latest:
Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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How to Select Pharmaceutical Dust Collectors in Accordance with the New ASHRAE Standard 199The pharmaceutical industry now has a way to accurately evaluate and compare dust collection systems that are self-cleaning
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Innovations and Future Trends in HPLC Column TechnologyDevelopments in chromatography column technology to deliver greater efficiency, speed and inertness benefit the drug development process from discovery to manufacturing and quality control.
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Advancements in Extrusion-SpheronizationMore agile techniques are improving the development of multiparticulate drug-delivery systems.
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
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Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
Latest:
Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
