Manufacturing

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Hybrid Design Considerations in Biomanufacturing: Leveraging Both Stainless-Steel and Single-Use Systems
Facility Design/Engineering
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Change Is Difficult, But It Is Inevitable: The Value of Integrated Project Delivery to Biomanufacturing-Facility Construction
Facility Design/Engineering
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May 23, 2023
Pharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the Clinic
QA/QC
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byLauren Schoukroun-Barnes, Dianne Cantaraand 2 more
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Digital Transformation in Biopharmaceutical Operations
Information Technology
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byDani Edmunds, Fausto Artico
May 23, 2023
Cleaning Validation Acceptance Limits for Biological Process Residues: Part 1 — Acceptable Exposure of Degraded Proteins Based on Reference
Validation
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May 23, 2023
Two-pronged approach advances Omisirge accessibility, says Gamida
Regulations
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byMillie Nelson
May 18, 2023
1 Min Read
Streamlining and Accelerating Biosimilar Adoption in the United States logo in a gray background | Streamlining and Accelerating Biosimilar Adoption in the United States
Biosimilars
Streamlining and Accelerating Biosimilar Adoption in the United States
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May 17, 2023
byJin Ah Jung
High Precision: Automated Aseptic Filling of Small Volumes
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High Precision: Automated Aseptic Filling of Small Volumes
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May 3, 2023
byBrian Moloney
Purpose-Built Viral-Vector Facility Construction: Applying Quality and Engineering Controls
Sponsored Content
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May 2, 2023
byAtef Khezri
eBook: BPI Lab — Patterns, Peaks, and Trends: Advantages of Digital Data for Biopharmaceutical Quality Control
Sponsored Content
eBook: BPI Lab — Patterns, Peaks, and Trends: Advantages of Digital Data for Biopharmaceutical Quality Control
eBook: BPI Lab — Patterns, Peaks, and Trends: Advantages of Digital Data for Biopharmaceutical Quality Control
Apr 24, 2023
byTim Sandle
Cell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics
Cell Line Development
Cell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics
Cell Lines Are the Foundation: A Methodical Approach to Derisking Outsourced Development and Improving Manufacturability of Novel Biologics
Apr 20, 2023
byJason Condon
Overcoming the Digital Divide: Leveraging Intelligent Automation and Informatics Expertise
Information Technology
Overcoming the Digital Divide: Leveraging Intelligent Automation and Informatics Expertise
Overcoming the Digital Divide: Leveraging Intelligent Automation and Informatics Expertise
Apr 20, 2023
byKarl-Heinz Loebel, Jim Nichols
Biopharma 4.0 — the Talent Evolution
Information Technology
Biopharma 4.0 — the Talent Evolution
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Apr 20, 2023
+5
byJason Beckwith, Robbie Dooland 5 more
Strengthening Data Management and Integrity for CGT Applications logo in a gray background | Strengthening Data Management and Integrity for CGT Applications
Cell Therapies
Strengthening Data Management and Integrity for CGT Applications
Strengthening Data Management and Integrity for CGT Applications
Apr 20, 2023
byKwok Pang
ELEVECTA<sup>TM</sup> &mdash; Truly Stable and Inducible Producer Cell Line for Large Scale AAV Manufacturing
Sponsored Content
ELEVECTATM — Truly Stable and Inducible Producer Cell Line for Large Scale AAV Manufacturing
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Apr 20, 2023
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byBPI Contributor
Advances in Bioanalytical Tools for the Characterization of In-Process Viral Samples
Sponsored Content
Advances in Bioanalytical Tools for the Characterization of In-Process Viral Samples April 2023
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Apr 4, 2023
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byBPI Contributor
eBook: The Post-Pandemic Supply Chain
Supply Chain
eBook: The Post-Pandemic Supply Chain
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Mar 27, 2023
+1
byDan Stanton, Millie Nelsonand 1 more
Introduction: Practicalities of Aseptic Processing for Modern Biological Drug Products
Fill/Finish
Introduction: Practicalities of Aseptic Processing for Modern Biological Drug Products
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Mar 21, 2023
byCheryl Scott
Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System
CMC Forums
Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System
Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System
Mar 21, 2023
byDavid W. Murray
Predictive Algorithm Modeling for Early Assessments in Downstream Processing: Using Direct Transition and Moment Analysis To Assess Chromatography
Chromatography
Predictive Algorithm Modeling for Early Assessments in Downstream Processing: Using Direct Transition and Moment Analysis To Assess Chromatography Column Integrity at Production Scale
Predictive Algorithm Modeling for Early Assessments in Downstream Processing: Using Direct Transition and Moment Analysis To Assess Chromatography Column Integrity at Production Scale
Mar 21, 2023
+4
byNahee Kim, Soonbin Kwonand 4 more
Advances Toward Dry-Powder Formulations for Monoclonal Antibodies
Formulation
Advances Toward Dry-Powder Formulations for Monoclonal Antibodies
Advances Toward Dry-Powder Formulations for Monoclonal Antibodies
Mar 21, 2023
byBrian Gazaille, Robert O. Williams III
eBook: Bioprocess Monitoring &mdash; Still on the Path to Dynamic Control
Sponsored Content
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Mar 15, 2023
byBrian Gazaille
Accelerating Antibody Characterization and AAV Analytics Using Next Gen Biolayer Interferometry (BLI)
Sponsored Content
Accelerating Antibody Characterization and AAV Analytics Using Next Gen Biolayer Interferometry (BLI)
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Mar 10, 2023
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20 Min View
byBPI Contributor
Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture
Sponsored Content
Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture
Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture
Mar 2, 2023
+1
byOleksandr Karpenko, Jigar Pateland 1 more
The Talent Enigma in Digital Biomanufacturing
Careers & Training
The Talent Enigma in Digital Biomanufacturing
The Talent Enigma in Digital Biomanufacturing
Feb 9, 2023
+5
byJason Beckwith, Paul Rooneyand 5 more
Delivering the Digital Skills Needs of the Bioprocessing Sector: Realizing the Vision of Industry 4.0 for Your Organization
Careers & Training
Delivering the Digital Skills Needs of the Bioprocessing Sector: Realizing the Vision of Industry 4.0 for Your Organization
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Feb 9, 2023
+2
bySuzanne S. Farid, Duygu Dikiciogluand 2 more
Real-Time, Data-Driven, and Predictive Modeling: Accelerating Digital Transformation in Drug Substance Commercial Manufacturing
PAT
Real-Time, Data-Driven, and Predictive Modeling: Accelerating Digital Transformation in Drug Substance Commercial Manufacturing
Real-Time, Data-Driven, and Predictive Modeling: Accelerating Digital Transformation in Drug Substance Commercial Manufacturing
Feb 9, 2023
+1
byPablo J. Rosado, Badua Merheband 1 more
Save Valuable Facility Time with Single-Use TFF
Sponsored Content
Save Valuable Facility Time with Single-Use TFF
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Feb 9, 2023
+2
byFranziska Froboese, Katy McLaughlinand 2 more
Grow Your CDMO with Automated Aseptic-Filling Workcells logo in a gray background | Grow Your CDMO with Automated Aseptic-Filling Workcells
Sponsored Content
Grow Your CDMO with Automated Aseptic-Filling Workcells
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Feb 9, 2023
byJohn Harmer
How To Achieve DSCSA Compliance by November 2023
Supply Chain
How To Achieve DSCSA Compliance by November 2023
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Feb 9, 2023
byAndre Caprio
Rapid and Efficient Measurement of Critical Quality Attributes and Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems
Sponsored Content
Rapid and Efficient Measurement of Critical Quality Attributes and Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems
Rapid and Efficient Measurement of Critical Quality Attributes and Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems
Feb 1, 2023
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1 Min Read
byBPI Contributor
Cell Therapy &mdash; Supply Chain Discussions
Supply Chain
Cell Therapy — Supply Chain Discussions
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Dec 15, 2022
+3
byDan Stanton, Gareth Macdonaldand 3 more
Simplify Residual DNA Quantitation in Viral Vector Production With qPCR and dPCR Tools
Sponsored Content
Simplify Residual DNA Quantitation in Viral Vector Production With qPCR and dPCR Tools
Simplify Residual DNA Quantitation in Viral Vector Production With qPCR and dPCR Tools
Dec 13, 2022
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20 Min View
byBPI Contributor
Container Materials for Biopharmaceuticals: A Comparative Small-Scale Case Study of Stainless Steel and a Proprietary Nickel-Based Alloy
Single Use
Container Materials for Biopharmaceuticals: A Comparative Small-Scale Case Study of Stainless Steel and a Proprietary Nickel-Based Alloy
Container Materials for Biopharmaceuticals: A Comparative Small-Scale Case Study of Stainless Steel and a Proprietary Nickel-Based Alloy
Dec 12, 2022
+5
bySonia Bedi, Mintai Peter Hwangand 5 more
Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications
Sponsored Content
Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications
Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications
Dec 8, 2022
+1
byMarc Hogreve, Inga Reinertand 1 more

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Register Now: Big Impact from Small Samples: Harnessing High-Precision Tunable Laser Spectroscopy for Complex Bioprocessing Analysis
Register Now: Big Impact from Small Samples: Harnessing High-Precision Tunable Laser Spectroscopy for Complex Bioprocessing Analysis
Ask the Expert webcasts
ATE Webcasts
Register Now: Advancing mRNA and CircRNA-based Vaccines and Therapeutics in CMC: From Process Development to Analytics
Register Now: Advancing mRNA and CircRNA-based Vaccines and Therapeutics in CMC: From Process Development to Analytics
Insider News
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Jun 5 - Jun 6, 2024
Exploit Advances in Exosomes to Improve Efficiencies in Drug Delivery: Connect with senior-level executives and scientists who will share new data and novel case studies on advancing EV products through clinical stage towards commercialization
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Peptones: A Powerful Tool for Manufacturing Complex Protein Therapies
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Nov 21, 2024

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