Biochemicals/Raw Materials

Comprehensive risk assessment framework
Biochemicals/Raw Materials
Buffer and Solution Mixing-Time Validation: A Risk-Assessment Framework for Analysts Using Matrix and Bracketing ApproachesBuffer and Solution Mixing-Time Validation: A Risk-Assessment Framework for Analysts Using Matrix and Bracketing Approaches

+6
byNaveenganesh Muralidharan, Leya S. Roseand 6 more
Jan 29, 2025
Continued Process Verification: A Multivariate, Data-Driven Modeling Application for Monitoring Raw Materials Used in Biopharmaceutical Manufacturing
Biochemicals/Raw Materials
Continued Process Verification: A Multivariate, Data-Driven Modeling Application for Monitoring Raw Materials Used in Biopharmaceutical ManufacturingContinued Process Verification: A Multivariate, Data-Driven Modeling Application for Monitoring Raw Materials Used in Biopharmaceutical Manufacturing
byHao Wei, John Masonand 1 more
Jun 26, 2023
Tris, a Critical Raw Material: Improving the Quality and Consistency of Supply
Sponsored Content
Tris, a Critical Raw Material: Improving the Quality and Consistency of SupplyTris, a Critical Raw Material: Improving the Quality and Consistency of Supply
byCheryl Scott
Dec 21, 2021
Optimizing the AAV Transfection Process in Suspension Cells
Cell Therapies
Optimizing the AAV Transfection Process in Suspension CellsOptimizing the AAV Transfection Process in Suspension Cells
byMatthias Hebben, Alengo Nyamay'antu
Oct 29, 2021
Viral Safety of Viral Vectors:<br> Special Concerns Arise When the Virus Is the Product
Viral Clearance
Viral Safety of Viral Vectors: Special Concerns Arise When the Virus Is the ProductViral Safety of Viral Vectors: Special Concerns Arise When the Virus Is the Product
byCheryl Scott, Hazel Aranha
Oct 29, 2021
Transfection Best Practices for AAV Gene Therapy Programs
Sponsored Content
Transfection Best Practices for AAV Gene Therapy ProgramsTransfection Best Practices for AAV Gene Therapy Programs
byAnn Rossi Bilodeau, Alengo Nyamay'antuand 1 more
Oct 28, 2021
Recombinant Proteins for Cell and Gene Therapy Research: A Conversation with Shenandoah Biotechnology
Sponsored Content
Recombinant Proteins for Cell and Gene Therapy Research: A Conversation with Shenandoah Biotechnology
Recombinant Proteins for Cell and Gene Therapy Research: A Conversation with Shenandoah Biotechnology
Oct 20, 2021
byBPI Contributor, Pamela De Lacy
Spontaneous Infection: Did You Leave the Back Door Open to Your Cultivation Suite?
Biochemicals/Raw Materials
Spontaneous Infection: Did You Leave the Back Door Open to Your Cultivation Suite?
Spontaneous Infection: Did You Leave the Back Door Open to Your Cultivation Suite?
Sep 30, 2021
+9
byRobert Boulanger, Marc Pelletierand 9 more
Ask the Expert: Leveraging Quality Management Systems to Achieve Competitive Advantages logo in a gray background | Ask the Expert: Leveraging Quality Management Systems to Achieve Competitive Advantages
Sponsored Content
Ask the Expert: Leveraging Quality Management Systems to Achieve Competitive Advantages
Ask the Expert: Leveraging Quality Management Systems to Achieve Competitive Advantages
Sep 17, 2021
byBPI Contributor
Take Complexity and Risk Out of Regulatory Compliance
Sponsored Content
Take Complexity and Risk Out of Regulatory Compliance
Take Complexity and Risk Out of Regulatory Compliance
Aug 12, 2021
byChantale Julien
Raw Materials for Advanced Therapies: When the Process Is the Product, Ingredients Are Key
Cell Therapies
Raw Materials for Advanced Therapies: When the Process Is the Product, Ingredients Are Key
Raw Materials for Advanced Therapies: When the Process Is the Product, Ingredients Are Key
Jun 18, 2021
+1
byBrian Gazaille, Bill Janssenand 1 more
Cell Banking in the Spotlight: Advising Biologics Developers About Cell Bank Preparation and Characterization
Cell Line Development
Cell Banking in the Spotlight: Advising Biologics Developers About Cell Bank Preparation and Characterization
Cell Banking in the Spotlight: Advising Biologics Developers About Cell Bank Preparation and Characterization
Jun 7, 2021
+1
byBrian Gazaille, Francisco Castilloand 1 more
Compounded Media Powder Streamlines Cell Culture Media Preparation Operations
Cell Culture Media
Compounded Media Powder Streamlines Cell Culture Media Preparation Operations
Compounded Media Powder Streamlines Cell Culture Media Preparation Operations
Mar 9, 2021
byYuval Shimoni, Volker Moehrle
Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures
Regulatory Affairs
Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures
Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures
Feb 4, 2021
+1
byOle Bødtker Nielsen, Marc Wintgensand 1 more
Intensified Seed Train Strategy for Faster, Cost-Effective Scale-Up of Biologics Manufacturing
Sponsored Content
Intensified Seed Train Strategy for Faster, Cost-Effective Scale-Up of Biologics Manufacturing
Intensified Seed Train Strategy for Faster, Cost-Effective Scale-Up of Biologics Manufacturing
Dec 6, 2020
+5
byJens-Christoph Matuszczyk, Johannes Lemkeand 5 more
Cryopreserved Leukapheresis Materials Help Alleviate Donor Sourcing Issues logo in a gray background | Cryopreserved Leukapheresis Materials Help Alleviate Donor Sourcing Issues
Biochemicals/Raw Materials
Cryopreserved Leukapheresis Materials Help Alleviate Donor Sourcing Issues
Cryopreserved Leukapheresis Materials Help Alleviate Donor Sourcing Issues
Dec 6, 2020
byBrad Taylor, Dominic Clarke, PhD
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
Using Peptones to Achieve Diverse and Demanding Bioproduction Goals
Sponsored Content
Using Peptones to Achieve Diverse and Demanding Bioproduction Goals
Using Peptones to Achieve Diverse and Demanding Bioproduction Goals
Sep 30, 2020
byStacy Holdread
Toward a Roadmap for Cell-Free Synthesis in Bioprocessing
Expression Platforms
Toward a Roadmap for Cell-Free Synthesis in Bioprocessing
Toward a Roadmap for Cell-Free Synthesis in Bioprocessing
Sep 22, 2020
+6
byBeatrice Melinek, Noelle Colantand 6 more
Microbial Expression and Purification: One Company’s Historical Perspective
Biochemicals/Raw Materials
Microbial Expression and Purification: One Company’s Historical Perspective
Microbial Expression and Purification: One Company’s Historical Perspective
Sep 22, 2020
+1
byChristopher H. Taron, James C. Samuelsonand 1 more
BVDV Risk Mitigation: Dealing with Bovine Viral Diarrhea Virus in Serum
Biochemicals/Raw Materials
BVDV Risk Mitigation: Dealing with Bovine Viral Diarrhea Virus in Serum
BVDV Risk Mitigation: Dealing with Bovine Viral Diarrhea Virus in Serum
Apr 13, 2020
+4
bySteven Doelger, Lisa Orfeand 4 more
Brazilian JBS Federally Inspected Fetal Bovine Serum
Sponsored Content
Brazilian JBS Federally Inspected Fetal Bovine Serum
Brazilian JBS Federally Inspected Fetal Bovine Serum
Apr 13, 2020
byPaulo A. Reimann
Upstream: Make the Right Decisions for Your mAb
Sponsored Content
Upstream: Make the Right Decisions for Your mAb
Upstream: Make the Right Decisions for Your mAb
Jan 27, 2020
byBPI Contributor
A Challenging Future for Fetal Bovine Serum
Biochemicals/Raw Materials
A Challenging Future for Fetal Bovine Serum
A Challenging Future for Fetal Bovine Serum
Sep 21, 2019
byJennifer Murray
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Viral Clearance
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Nov 10, 2018
byCheryl Scott
eBook: Raw Materials Quality, Processing, and Storage &mdash; A Manufacturing Case Study
Biochemicals/Raw Materials
eBook: Raw Materials Quality, Processing, and Storage — A Manufacturing Case Study
eBook: Raw Materials Quality, Processing, and Storage — A Manufacturing Case Study
Jun 13, 2018
+2
byMaribel Rios, Bunyada Kwongand 2 more
Enhanced Galactosylation of Monoclonal Antibodies: Using Medium Supplements and Precursors of UDP-Galactose, Part 1
Cell Culture Media
Enhanced Galactosylation of Monoclonal Antibodies: Using Medium Supplements and Precursors of UDP-Galactose, Part 1
Enhanced Galactosylation of Monoclonal Antibodies: Using Medium Supplements and Precursors of UDP-Galactose, Part 1
Feb 16, 2018
+2
byRoger Anderson, Lindsay Hockand 2 more
Addressing the Challenge of Complex Buffer Management: An In-Line Conditioning Collaboration
Separation/Purification
Addressing the Challenge of Complex Buffer Management: An In-Line Conditioning Collaboration
Addressing the Challenge of Complex Buffer Management: An In-Line Conditioning Collaboration
Dec 13, 2017
+3
byDavide Fabbrini, Carlo Simoniniand 3 more
Buffers in Biologics Manufacturing
QA/QC
Buffers in Biologics Manufacturing
Buffers in Biologics Manufacturing
Feb 13, 2017
+2
byAngela Linderholm, Steven M. Chamowand 2 more
Setting Raw-Material Specifications Using Prediction Models: Determination of a Specification Limit for a Raw-Material Impurity in mPEG-Aldehyde
Biochemicals/Raw Materials
Setting Raw-Material Specifications Using Prediction Models: Determination of a Specification Limit for a Raw-Material Impurity in mPEG-Aldehyde
Setting Raw-Material Specifications Using Prediction Models: Determination of a Specification Limit for a Raw-Material Impurity in mPEG-Aldehyde
Jan 19, 2017
+3
byLisandra Negron-Vega, Kirla Maurasand 3 more
Viral Risk Evaluation of Raw Materials Used in Biopharmaceutical Production
QA/QC
Viral Risk Evaluation of Raw Materials Used in Biopharmaceutical Production
Viral Risk Evaluation of Raw Materials Used in Biopharmaceutical Production
Oct 14, 2016
+3
byYuval Shimoni, Andre Pastorand 3 more
Multivariate Analysis of Biological Additives for Growth Media and Feeds
Biochemicals/Raw Materials
Multivariate Analysis of Biological Additives for Growth Media and Feeds
Multivariate Analysis of Biological Additives for Growth Media and Feeds
Mar 11, 2016
byRonan D. O'Kennedy
A Risk-Based Approach to Supplier and Raw Materials Management
Biochemicals/Raw Materials
A Risk-Based Approach to Supplier and Raw Materials Management
A Risk-Based Approach to Supplier and Raw Materials Management
Nov 17, 2015
+1
byYuval Shimoni, Venkatesh Srinivasanand 1 more
Comparison of Concentration Measurement Technologies in Bioprocess Solutions
Biochemicals/Raw Materials
Comparison of Concentration Measurement Technologies in Bioprocess Solutions
Comparison of Concentration Measurement Technologies in Bioprocess Solutions
Oct 15, 2015
+3
byMichael W. Johnson, Kevin Goldenand 3 more
Strategies for Microcarrier Culture Optimization
Sponsored Content
Strategies for Microcarrier Culture Optimization
Strategies for Microcarrier Culture Optimization
Sep 16, 2015
byMark Szczypka, Alain Fairbank

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