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Abstract: 

Bigger is Better in Samsung's Approach to Biomanufacturing, 3p.

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CMO Roundup: Expansions for Biomanufacturing, 2p.

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Designing a Single-Use Biopharmaceutical Process, 2p.

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FDA is Not Playing Games with Biosimilars, 1p.

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FDA Seeks to Revive Quality Metrics Initiative, 2p.

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Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification, 4p.

Abstract: 

Multi-Purpose Biopharmaceutical Manufacturing Facilities, 5p.

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USP’s Update to Compounding Rules Could Affect Cleanroom Design

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What Ifs in the Five-Year Plan, 2p.

Article: 

Aseptic Production, Gowning Systems and Airborne Contaminants

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Assuring the Safe Handling of Potent APIs, Intermediates, and Solid-Dosage Drugs

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Best Practices for Design and Operation of Multiproduct Manufacturing Facilities

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Best Practices for Design and Operation of Multiproduct Manufacturing Facilities

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Best Practices in Using Isolator Technology

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Best Practices in Using Isolator Technology

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Bioprocessing Facilities and FDA Inspection Problems

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Choosing a Cleanroom Infrastructure Technology

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Cleanroom Cleaning: Proper Methodology and Determining Efficacy by Ryan Burke, and Madison Prifti

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CMOs Leading the Way on Single-Use Systems Adoption

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Continuous Manufacturing Gains Major Push from FDA

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Electrodeionization in Pharmaceutical Water Treatment

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Embracing the Digital Factory for Bio/Pharma Manufacturing

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FDA Advances New Approach to Drug Quality Assessment

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Getting to the Root of Quality Problems

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GMPs Guide COVID-19 Vaccine Manufacturing

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HPAPI Capacity Challenges, 4p.

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Human-Centered Work: How Pharma Can Move to a Blame-Free Culture

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Improving Efficiency for Sustainable Pharmaceutical Facilities

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Inhalation Drug Delivery: the Impact of Particle Size Reduction, 4p.

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Inside Italy’s Pharmaceutical Industry by Abi Millar

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Integrating Industrial Internet of Things (IoT)and Pharmaceutical Manufacturing Processes

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Intelligent Packaging Promotes Interaction with Patients

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Navigating Uncharted Waters. Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

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Not a Particle of Doubt

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Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy Facilities

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Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

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Performing Remote Audits During the Pandemic

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Pharma Contract Market Update, 3p.

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Pharma Facilities Still Have a Lot to Learn

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Qualification of a Swab Sampling Procedure for Cleaning Validation

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Real-World Vapor Phase Hydrogen Peroxide Decontamination

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Resuming Operations During a Pandemic

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Risk-Averse Fill/Finish Industry Embraces Change, 4p.

Article: 

Robotics Solve Aseptic Filling Challenges, 3p.

Article: 

Understanding the Critical Role of Integrity Testing in Laboratory Sterility Filtration

Article: 

Understanding the Impact of Annex 1 on Isolator Design