Validation

eBook: Development of a Representative Scale-Down UF/DF Model: Overcoming Equipment Limitations and Associated Process Challenges
Bioanalytical Methods
eBook: Development of a Representative Scale-Down UF/DF Model: Overcoming Equipment Limitations and Associated Process ChallengeseBook: Development of a Representative Scale-Down UF/DF Model: Overcoming Equipment Limitations and Associated Process Challenges

+1
byLawrence Huang, Zachary Rogersand 1 more
Feb 28, 2018
Antibody Higher Order Structure Stability: Polymorphism Revealed By Protein Conformational Array
Validation
Antibody Higher Order Structure Stability: Polymorphism Revealed By Protein Conformational ArrayAntibody Higher Order Structure Stability: Polymorphism Revealed By Protein Conformational Array
byXing Wang, Lavanya Kolluruand 2 more
Nov 16, 2017
Development of a Host-Cell Protein Platform Assay for a Chinese Hamster Ovary Cell Line
QA/QC
Development of a Host-Cell Protein Platform Assay for a Chinese Hamster Ovary Cell LineDevelopment of a Host-Cell Protein Platform Assay for a Chinese Hamster Ovary Cell Line
byStefan Haemmig, Josiane Tenudand 4 more
Oct 18, 2017
Aggregation from Shear Stress and Surface Interaction: Molecule-Specific or Universal Phenomenon?
Formulation
Aggregation from Shear Stress and Surface Interaction: Molecule-Specific or Universal Phenomenon?Aggregation from Shear Stress and Surface Interaction: Molecule-Specific or Universal Phenomenon?
byDouglas Nesta, Tatiana Nandaand 6 more
Apr 17, 2017
Conditional/Inducible Gene-Expression Mouse Models Using Advanced Gene Editing
Process Development
Conditional/Inducible Gene-Expression Mouse Models Using Advanced Gene EditingConditional/Inducible Gene-Expression Mouse Models Using Advanced Gene Editing
byNeeraja Parameswaran, Lanna Coxand 3 more
Mar 20, 2017
Residual Host-Cell DNA in Biopharmaceutical Products: 96-Well Plate-Based Extraction and Real-Time PCR Assay for Quantitative Measurement
QA/QC
Residual Host-Cell DNA in Biopharmaceutical Products: 96-Well Plate-Based Extraction and Real-Time PCR Assay for Quantitative MeasurementResidual Host-Cell DNA in Biopharmaceutical Products: 96-Well Plate-Based Extraction and Real-Time PCR Assay for Quantitative Measurement
byBing Hu, Robert Peglowand 4 more
Feb 13, 2017
A Statistical Approach to Assess and Justify Potential Product Specifications
QA/QC
A Statistical Approach to Assess and Justify Potential Product Specifications
A Statistical Approach to Assess and Justify Potential Product Specifications
Feb 13, 2017
byTodd Coffey, PhD, Keith M. Bower
Examining Single-Use Harvest Clarification Options: A Case Study Comparing Depth-Filter Turbidities and Recoveries
Filtration
Examining Single-Use Harvest Clarification Options: A Case Study Comparing Depth-Filter Turbidities and Recoveries
Examining Single-Use Harvest Clarification Options: A Case Study Comparing Depth-Filter Turbidities and Recoveries
Feb 13, 2017
+2
byManish K. Sharma, Snehal Raikarand 2 more
CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification
CMC Forums
CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification
CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification
Jan 19, 2017
+5
byJR Dobbins, Stefanie Pluschkelland 5 more
Response to the Publication of USP ‹1207›
QA/QC
Response to the Publication of USP ‹1207›
Response to the Publication of USP ‹1207›
Jan 19, 2017
+16
byBrian Vanness, Stephen Yiand 16 more
HCP Antigens and Antibodies from Different CHO Cell Lines
QA/QC
HCP Antigens and Antibodies from Different CHO Cell Lines
HCP Antigens and Antibodies from Different CHO Cell Lines
Jan 19, 2017
+4
byHaiyan Liu, Will Richesand 4 more
Using Technology to Overcome Bioprocessing Complexity: Advanced Concentration and Analytical Technologies Accelerate Development and Manufacture of
Sponsored Content
Using Technology to Overcome Bioprocessing Complexity: Advanced Concentration and Analytical Technologies Accelerate Development and Manufacture of mAbs, Vaccines, and Biosimilars
Using Technology to Overcome Bioprocessing Complexity: Advanced Concentration and Analytical Technologies Accelerate Development and Manufacture of mAbs, Vaccines, and Biosimilars
Jun 27, 2016
byEngin Ayturk, Jeannette Marshall
Clearance of Persistent Small-Molecule Impurities: Alternative Strategies
Bioanalytical Methods
Clearance of Persistent Small-Molecule Impurities: Alternative Strategies
Clearance of Persistent Small-Molecule Impurities: Alternative Strategies
May 11, 2016
+2
byAlan K. Hunter, Andrew Fultonand 2 more
Best Practices for Critical Sterile Filter Operation: A Case Study
Filtration
Best Practices for Critical Sterile Filter Operation: A Case Study
Best Practices for Critical Sterile Filter Operation: A Case Study
May 11, 2016
+3
byYanglin Mok, Lise Besnardand 3 more
CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview
CMC Forums
CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview
CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview
Apr 12, 2016
+18
byCheryl Scott, Siddharth J. Advant, PhDand 18 more
Using Optical Sensors for Bioprocess Monitoring: A Measurement Technique for Bioprocessors
Bioreactors
Using Optical Sensors for Bioprocess Monitoring: A Measurement Technique for Bioprocessors
Using Optical Sensors for Bioprocess Monitoring: A Measurement Technique for Bioprocessors
Mar 14, 2016
byGernot Thomas John
Detecting the Broad Spectrum of Pyrogens with the Human Whole-Blood Monocyte Activation Test
Bioanalytical Methods
Detecting the Broad Spectrum of Pyrogens with the Human Whole-Blood Monocyte Activation Test
Detecting the Broad Spectrum of Pyrogens with the Human Whole-Blood Monocyte Activation Test
Mar 11, 2016
+1
byThomas Hartung, Audrey Boreland 1 more
Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter
Bioanalytical Methods
Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter
Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter
Feb 11, 2016
byLeah Rosin
High-Throughput Methods Evaluation: Impurities Determination During Upstream and Downstream In-Process Development
Assays
High-Throughput Methods Evaluation: Impurities Determination During Upstream and Downstream In-Process Development
High-Throughput Methods Evaluation: Impurities Determination During Upstream and Downstream In-Process Development
Feb 4, 2016
+4
byEike Zimmermann, Lin Wangand 4 more
Using Glycosidases to Remove, Trim, or Modify Glycans on Therapeutic Proteins
Cell Line Development
Using Glycosidases to Remove, Trim, or Modify Glycans on Therapeutic Proteins
Using Glycosidases to Remove, Trim, or Modify Glycans on Therapeutic Proteins
Feb 4, 2016
byEllen P. Guthrie, Paula E. Magnelli
Development of a Novel Host-Cell Protein Assay: Supporting the <i>Physcomitrella patens</i> Expression System
Bioanalytical Methods
Development of a Novel Host-Cell Protein Assay: Supporting the Physcomitrella patens Expression System
Development of a Novel Host-Cell Protein Assay: Supporting the Physcomitrella patens Expression System
Feb 4, 2016
+4
byPaulina Dabrowska-Schlepp, Stefan Sommerschuhand 4 more
Experiences with a Benchtop-Scale Glass Bioreactor: Engineering Data and Cultivation Results
Bioreactors
Experiences with a Benchtop-Scale Glass Bioreactor: Engineering Data and Cultivation Results
Experiences with a Benchtop-Scale Glass Bioreactor: Engineering Data and Cultivation Results
Nov 16, 2015
+2
byStephan C. Kaiser, Nadezda Perepelitsaand 2 more
Identification and Quantification of Heat-Shock Protein 70: A Major Host-Cell Protein Contaminant from HEK Host Cells
Viral Clearance
Identification and Quantification of Heat-Shock Protein 70: A Major Host-Cell Protein Contaminant from HEK Host Cells
Identification and Quantification of Heat-Shock Protein 70: A Major Host-Cell Protein Contaminant from HEK Host Cells
Oct 15, 2015
+6
byXiaohui Lu, Chong-Feng Xuand 6 more
Evaluation of a Variable-Pathlength Spectrophotometer: A Comparable Instrument for Determining Protein Concentration
Bioanalytical Methods
Evaluation of a Variable-Pathlength Spectrophotometer: A Comparable Instrument for Determining Protein Concentration
Evaluation of a Variable-Pathlength Spectrophotometer: A Comparable Instrument for Determining Protein Concentration
Jun 16, 2015
+2
byBriana Lehr, John Robinsonand 2 more
Fundamental Strategies for Viral Clearance Part 2: Technical Approaches
Viral Clearance
Fundamental Strategies for Viral Clearance Part 2: Technical Approaches
Fundamental Strategies for Viral Clearance Part 2: Technical Approaches
May 12, 2015
byKathryn Martin Remington
Reagent Clearance Capability of Protein A Chromatography: A Platform Strategy for Elimination of Process Reagent Clearance Testing
Chromatography
Reagent Clearance Capability of Protein A Chromatography: A Platform Strategy for Elimination of Process Reagent Clearance Testing
Reagent Clearance Capability of Protein A Chromatography: A Platform Strategy for Elimination of Process Reagent Clearance Testing
May 12, 2015
+1
byXiaoyang Zhao, Henry Linand 1 more
Foundation Elements for Cell Therapy Smart Scaling
Cell Therapies
Foundation Elements for Cell Therapy Smart Scaling
Foundation Elements for Cell Therapy Smart Scaling
Apr 15, 2015
+3
byYonatan Levinson, Yonatan Eylonand 3 more
Hamster Phospholipase B-Like 2 (PLBL2): A Host-Cell Protein Impurity in Therapeutic Monoclonal Antibodies Derived from Chinese Hamster Ovary Cells
Bioanalytical Methods
Hamster Phospholipase B-Like 2 (PLBL2): A Host-Cell Protein Impurity in Therapeutic Monoclonal Antibodies Derived from Chinese Hamster Ovary Cells
Hamster Phospholipase B-Like 2 (PLBL2): A Host-Cell Protein Impurity in Therapeutic Monoclonal Antibodies Derived from Chinese Hamster Ovary Cells
Apr 14, 2015
+21
byMartin Vanderlaan, Wendy Sandovaland 21 more
Improved Fluorescent Labeling Efficiency of N-Linked, High-Mannose Oligosaccharides: Using 8-Aminopyrene-1,3,6-Trisulfonic Acid (APTS) for Analysis
MAb
Improved Fluorescent Labeling Efficiency of N-Linked, High-Mannose Oligosaccharides: Using 8-Aminopyrene-1,3,6-Trisulfonic Acid (APTS) for Analysis of Glycoproteins
Improved Fluorescent Labeling Efficiency of N-Linked, High-Mannose Oligosaccharides: Using 8-Aminopyrene-1,3,6-Trisulfonic Acid (APTS) for Analysis of Glycoproteins
Mar 10, 2015
+4
byYuling Zhang, Philip Campbelland 4 more
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal
Filtration
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal February 2015
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal February 2015
Feb 6, 2015
+5
byMario Metzger, Marcus Peikerand 5 more
Unwanted Immunogenicity: From Risk Assessment to Risk Management
Bioanalytical Methods
Unwanted Immunogenicity: From Risk Assessment to Risk Management
Unwanted Immunogenicity: From Risk Assessment to Risk Management
Nov 10, 2014
byCheryl Scott
Understanding and Controlling Sources of Process Variation: Risks to Achieving Product Critical Quality Attributes
Bioanalytical Methods
Understanding and Controlling Sources of Process Variation: Risks to Achieving Product Critical Quality Attributes
Understanding and Controlling Sources of Process Variation: Risks to Achieving Product Critical Quality Attributes
Oct 16, 2014
byNick Hutchinson
Replacing Reverse-Phase Chromatography for Mass Spectrometry: Is Salt-Free Size-Exclusion Chromatography Ready?
Formulation
Replacing Reverse-Phase Chromatography for Mass Spectrometry: Is Salt-Free Size-Exclusion Chromatography Ready?
Replacing Reverse-Phase Chromatography for Mass Spectrometry: Is Salt-Free Size-Exclusion Chromatography Ready?
Oct 16, 2014
byXi Lin, Jichao Kang
Preuse, Poststerilization Filter Integrity Testing for Single-Use and Stainless-Steel Installations
Filtration
Preuse, Poststerilization Filter Integrity Testing for Single-Use and Stainless-Steel Installations
Preuse, Poststerilization Filter Integrity Testing for Single-Use and Stainless-Steel Installations
Oct 16, 2014
byMagnus Stering
Pressure Decay Method for Postinstallation Single-Use Bioreactor Bag Testing
Single Use
Pressure Decay Method for Postinstallation Single-Use Bioreactor Bag Testing
Pressure Decay Method for Postinstallation Single-Use Bioreactor Bag Testing
Sep 23, 2014
+3
byMagnus Stering, Martin Dahlbergand 3 more

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