Process Monitoring and Controls

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Regulations
Sterile Filtration Process Control: Meeting Regulatory ExpectationsSterile Filtration Process Control: Meeting Regulatory Expectations

byLibby Russell
Mar 6, 2024
Pharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the Clinic
QA/QC
Pharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the ClinicPharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the Clinic
byLauren Schoukroun-Barnes, Dianne Cantaraand 2 more
May 23, 2023
Cleaning Validation Acceptance Limits for Biological Process Residues: Part 1 — Acceptable Exposure of Degraded Proteins Based on Reference
Validation
Cleaning Validation Acceptance Limits for Biological Process Residues: Part 1 — Acceptable Exposure of Degraded Proteins Based on Reference ImmunogensCleaning Validation Acceptance Limits for Biological Process Residues: Part 1 — Acceptable Exposure of Degraded Proteins Based on Reference Immunogens
byRizwan Sharnez, Andrew Brewerand 15 more
May 23, 2023
eBook: BPI Lab — Patterns, Peaks, and Trends: Advantages of Digital Data for Biopharmaceutical Quality Control
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eBook: BPI Lab — Patterns, Peaks, and Trends: Advantages of Digital Data for Biopharmaceutical Quality ControleBook: BPI Lab — Patterns, Peaks, and Trends: Advantages of Digital Data for Biopharmaceutical Quality Control
byTim Sandle
Apr 24, 2023
eBook: Bioprocess Monitoring — Still on the Path to Dynamic Control
Sponsored Content
eBook: Bioprocess Monitoring — Still on the Path to Dynamic ControleBook: Bioprocess Monitoring — Still on the Path to Dynamic Control
byBrian Gazaille
Mar 15, 2023
Tangential-Flow Filtration Process Control and Data Acquisition System for Process Development
Sponsored Content
Tangential-Flow Filtration Process Control and Data Acquisition System for Process DevelopmentTangential-Flow Filtration Process Control and Data Acquisition System for Process Development
byMahesh Khot
Dec 6, 2022
Statistical Method for Establishing Control Limits for Nonnormal Data Distribution: Focus on Continued Process Verification Monitoring
Process Monitoring and Controls
Statistical Method for Establishing Control Limits for Nonnormal Data Distribution: Focus on Continued Process Verification Monitoring
Statistical Method for Establishing Control Limits for Nonnormal Data Distribution: Focus on Continued Process Verification Monitoring
Oct 20, 2022
byNaveenganesh Muralidharan
September 2022 Featured Report
Process Monitoring and Controls
September 2022 Featured Report
September 2022 Featured Report
Innovations in Cell Culture, Sensor Technology, and Process Control: Preparing for Industry 4.0
Sponsored Content
Innovations in Cell Culture, Sensor Technology, and Process Control: Preparing for Industry 4.0
Innovations in Cell Culture, Sensor Technology, and Process Control: Preparing for Industry 4.0
Aug 22, 2022
byJim Furey
Bioprocess Monitoring and Control: New and Continuing Needs in the Biopharmaceutical Industry
Sponsored Content
Bioprocess Monitoring and Control: New and Continuing Needs in the Biopharmaceutical Industry
Bioprocess Monitoring and Control: New and Continuing Needs in the Biopharmaceutical Industry
Aug 22, 2022
byNick Pittman, Magnus Wetterhall
Process Intelligence: Gene Therapy Case Study Shows That the Journey to Improved Capabilities Starts with One Step
Cell Therapies
Process Intelligence: Gene Therapy Case Study Shows That the Journey to Improved Capabilities Starts with One Step
Process Intelligence: Gene Therapy Case Study Shows That the Journey to Improved Capabilities Starts with One Step
Apr 19, 2022
byDermot McCaul
Automated Process Control Based on In Situ Measured Glucose Concentration
Sponsored Content
Automated Process Control Based on In Situ Measured Glucose Concentration
Automated Process Control Based on In Situ Measured Glucose Concentration
Dec 14, 2021
bySilvia Sturzenegger
Seamless Integration of Glucose Control: Using Raman Spectroscopy in CHO Cell Culture
Sponsored Content
Seamless Integration of Glucose Control: Using Raman Spectroscopy in CHO Cell Culture
Seamless Integration of Glucose Control: Using Raman Spectroscopy in CHO Cell Culture
Dec 8, 2021
+2
byCélia Sanchez, Laure Pétillotand 2 more
Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop
CMC Forums
Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop
Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop
Oct 28, 2021
+4
bySarah Kennett, Kristopher Barnthouseand 4 more
Multivariate Data-Driven Modeling for Continued Process Verification
Process Monitoring and Controls
Multivariate Data-Driven Modeling for Continued Process Verification
Multivariate Data-Driven Modeling for Continued Process Verification
Oct 28, 2021
+1
byShreya Maiti, Michal Mleczkoand 1 more
Advanced Data-Driven Modeling for Biopharmaceutical Purification Processes
Process Monitoring and Controls
Advanced Data-Driven Modeling for Biopharmaceutical Purification Processes
Advanced Data-Driven Modeling for Biopharmaceutical Purification Processes
Sep 30, 2021
byShreya Maiti, Konstantinos Spetsieris
Design and Performance of a New Single-Use pH Sensor with Long Shelf Life and High Stability
Sponsored Content
Design and Performance of a New Single-Use pH Sensor with Long Shelf Life and High Stability
Design and Performance of a New Single-Use pH Sensor with Long Shelf Life and High Stability
Aug 24, 2021
byBen Arriola, Jinbo Hu
Clamp-On Flow Meters for Process Monitoring
Sponsored Content
Clamp-On Flow Meters for Process Monitoring
Clamp-On Flow Meters for Process Monitoring
Aug 24, 2021
byFernando Rangel
August 2021
Process Monitoring and Controls
August 2021
August 2021
Validation of a Next-Generation Single-Use Turbidity System
Sponsored Content
Validation of a Next-Generation Single-Use Turbidity System
Validation of a Next-Generation Single-Use Turbidity System
Jun 18, 2021
byNick Troise
The Five Heresies of Cell Culture: Debunking Conventional Wisdom
Sponsored Content
The Five Heresies of Cell Culture: Debunking Conventional Wisdom
The Five Heresies of Cell Culture: Debunking Conventional Wisdom
Jun 11, 2021
byIan Sarad
Measuring Cell Density in HyPerforma S.U.B.s with ABER Futura neo<sub>tf</sub><br> Single-Use Sensors
Sponsored Content
Measuring Cell Density in HyPerforma S.U.B.s with ABER Futura neotf Single-Use Sensors
Measuring Cell Density in HyPerforma S.U.B.s with ABER Futura neotf Single-Use Sensors
Jun 11, 2021
+2
byBen Madsen, Nephi Jonesand 2 more
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 &mdash; Validation, Legacy Products, and Lifecycle Management
CMC Forums
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
Apr 16, 2021
+7
byZahra Shahrokh, Andrew Weiskopfand 7 more
Using Prior Knowledge to Estimate Long-Term Variation
Process Monitoring and Controls
Using Prior Knowledge to Estimate Long-Term Variation
Using Prior Knowledge to Estimate Long-Term Variation
Mar 9, 2021
byKeith M. Bower
Nontargeted HCP Monitoring in Downstream Process Samples: Combining Micro Pillar Array Columns with Mass Spectrometry
Sponsored Content
Nontargeted HCP Monitoring in Downstream Process Samples: Combining Micro Pillar Array Columns with Mass Spectrometry
Nontargeted HCP Monitoring in Downstream Process Samples: Combining Micro Pillar Array Columns with Mass Spectrometry
Dec 18, 2020
byJeff Op de Beeck, Paul Jacobs
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics
CMC Forums
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics
Dec 17, 2020
+8
byAnthony Mire-Sluis, Sarah Kennettand 8 more
Product Quality Attribute Shifts in Perfusion Systems, Part 2: Elucidating Cellular Mechanisms
Perfusion Cell Culture
Product Quality Attribute Shifts in Perfusion Systems, Part 2: Elucidating Cellular Mechanisms
Product Quality Attribute Shifts in Perfusion Systems, Part 2: Elucidating Cellular Mechanisms
Dec 17, 2020
+1
byYuval Shimoni, Lakshmi Prasad Pathangeand 1 more
Practical Considerations for Statistical Analyses in Continued Process Verification
Process Monitoring and Controls
Practical Considerations for Statistical Analyses in Continued Process Verification
Practical Considerations for Statistical Analyses in Continued Process Verification
Dec 17, 2020
byKeith M. Bower
Ultrasonic Flow and Bubble Sensors: Optimize Process Quality in Single-Use Bioprocessing Applications
Sponsored Content
Ultrasonic Flow and Bubble Sensors: Optimize Process Quality in Single-Use Bioprocessing Applications
Ultrasonic Flow and Bubble Sensors: Optimize Process Quality in Single-Use Bioprocessing Applications
Dec 17, 2020
byFrauke Beelman
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies
CMC Forums
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies
Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies
Oct 29, 2020
+7
byAnthony Mire-Sluis, Sarah Kennettand 7 more
Run Rules with Autocorrelated Data for Continued Process Verification
Continuous Bioprocessing
Run Rules with Autocorrelated Data for Continued Process Verification
Run Rules with Autocorrelated Data for Continued Process Verification
Oct 29, 2020
byKeith M. Bower
Endotoxin Questions and Answers
Sponsored Content
Endotoxin Questions and Answers
Endotoxin Questions and Answers
Oct 29, 2020
byCheryl Scott, Lisa Komski
eBook: Raw Material Control Strategy &mdash; Leveraging Knowledge of Material Attributes and Data Analytics as Key Elements
Biochemicals/Raw Materials
eBook: Raw Material Control Strategy — Leveraging Knowledge of Material Attributes and Data Analytics as Key Elements
eBook: Raw Material Control Strategy — Leveraging Knowledge of Material Attributes and Data Analytics as Key Elements
Oct 28, 2020
+1
bySusan Burke, Matthew Hammondand 1 more
Dissolved Oxygen Control Tuning for Cell Culture Applications
Sponsored Content
Dissolved Oxygen Control Tuning for Cell Culture Applications
Dissolved Oxygen Control Tuning for Cell Culture Applications
Sep 22, 2020
+1
byJohn Longsworth, Nina Schillingsand 1 more
Novel Integrated Raman Spectroscopy Technology for Minibioreactors: Accelerating Raman Model Building for Cell Culture Monitoring and Control
Sponsored Content
Novel Integrated Raman Spectroscopy Technology for Minibioreactors: Accelerating Raman Model Building for Cell Culture Monitoring and Control
Novel Integrated Raman Spectroscopy Technology for Minibioreactors: Accelerating Raman Model Building for Cell Culture Monitoring and Control
Sep 22, 2020
+2
byMichael Sibley, Angus Woodhamsand 2 more

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