2015

Featured on 2015

Special Report: Toward Sustainable Engineering Practices in Biologics Manufacturing
Sponsored Content
Special Report: Toward Sustainable Engineering Practices in Biologics ManufacturingSpecial Report: Toward Sustainable Engineering Practices in Biologics Manufacturing

+6
byKristi Budzinski, Sa Hoand 6 more
Dec 18, 2015
Advances in Bioprocessing: Single-Use and Stainless Steel Technologies
Facility Design/Engineering
Advances in Bioprocessing: Single-Use and Stainless Steel TechnologiesAdvances in Bioprocessing: Single-Use and Stainless Steel Technologies
byEric S. Langer
Dec 18, 2015
Disposable Components in Biomanufacturing: A Regulatory Perspective
Single Use
Disposable Components in Biomanufacturing: A Regulatory PerspectiveDisposable Components in Biomanufacturing: A Regulatory Perspective
byPeter Calcott
Dec 18, 2015
The Single-Use or Stainless Steel Decision Process: A CDMO Perspective
Single Use
The Single-Use or Stainless Steel Decision Process: A CDMO PerspectiveThe Single-Use or Stainless Steel Decision Process: A CDMO Perspective
byPeter Rogge, Dethardt Müllerand 1 more
Dec 18, 2015
Meeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering Challenge
Facility Design/Engineering
Meeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering ChallengeMeeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering Challenge
byAeby Thomas, Morten Munk
Dec 18, 2015
End-User Considerations: How Biopharmaceutical Companies and Their Employees Approach Single-Use and Stainless Steel
Single Use
End-User Considerations: How Biopharmaceutical Companies and Their Employees Approach Single-Use and Stainless SteelEnd-User Considerations: How Biopharmaceutical Companies and Their Employees Approach Single-Use and Stainless Steel
byS. Anne Montgomery
Dec 18, 2015

More from 2015

Choosing Between Single-Use and Multiuse Technologies: An Interphex 2015 Roundtable Discussion
Single Use
Choosing Between Single-Use and Multiuse Technologies: An Interphex 2015 Roundtable Discussion
Choosing Between Single-Use and Multiuse Technologies: An Interphex 2015 Roundtable Discussion
Dec 18, 2015
byCheryl Scott
Single-Use and Stainless Steel Technologies: Comparison, Contrast — Where Are They Going?
Facility Design/Engineering
Single-Use and Stainless Steel Technologies: Comparison, Contrast — Where Are They Going?
Single-Use and Stainless Steel Technologies: Comparison, Contrast — Where Are They Going?
Dec 18, 2015
byJames D. Vogel
Spotlight
Business
Spotlight December 2015
Spotlight December 2015
Dec 17, 2015
byBPI Staff
From the Editor
Business
From the Editor December 2015
From the Editor December 2015
Dec 17, 2015
byS. Anne Montgomery
Bioindustry Researchers Take Strides in Preventing Diseases: Developments in Genetic Diagnosis and Therapy
Economics
Bioindustry Researchers Take Strides in Preventing Diseases: Developments in Genetic Diagnosis and Therapy
Bioindustry Researchers Take Strides in Preventing Diseases: Developments in Genetic Diagnosis and Therapy
Dec 16, 2015
byPeter Huber
Accounting for Portfolio Risk: Creating an Analytical Framework for Optimizing the Portfolio Mix
Economics
Accounting for Portfolio Risk: Creating an Analytical Framework for Optimizing the Portfolio Mix
Accounting for Portfolio Risk: Creating an Analytical Framework for Optimizing the Portfolio Mix
Dec 16, 2015
byLeslie Sandberg Orne
From Silos to Synergy: Optimize Your Managed-Markets Division with Cross-Team Collaboration
Economics
From Silos to Synergy: Optimize Your Managed-Markets Division with Cross-Team Collaboration
From Silos to Synergy: Optimize Your Managed-Markets Division with Cross-Team Collaboration
Dec 16, 2015
byChris Lagoeiro
Standardization of Disposables Design: The Path Forward for a Potential Game Changer
Supply Chain
Standardization of Disposables Design: The Path Forward for a Potential Game Changer
Standardization of Disposables Design: The Path Forward for a Potential Game Changer
Dec 16, 2015
+2
byDavid Wolton, Luke Heavenand 2 more
From Chips to CHO Cells: IT Advances in Upstream Bioprocessing
Information Technology
From Chips to CHO Cells: IT Advances in Upstream Bioprocessing
From Chips to CHO Cells: IT Advances in Upstream Bioprocessing
Dec 16, 2015
byHelena Fan, Cheryl Scott
Decision-Support Tools for Monoclonal Antibody and Cell Therapy Bioprocessing: Current Landscape and Development Opportunities
MAb
Decision-Support Tools for Monoclonal Antibody and Cell Therapy Bioprocessing: Current Landscape and Development Opportunities
Decision-Support Tools for Monoclonal Antibody and Cell Therapy Bioprocessing: Current Landscape and Development Opportunities
Dec 16, 2015
+6
byRahul Rekhi, James A. Smithand 6 more
Primary and Higher-Order Structural Characterization Strategy for Biosimilarity Assessment
Biosimilars
Primary and Higher-Order Structural Characterization Strategy for Biosimilarity Assessment
Primary and Higher-Order Structural Characterization Strategy for Biosimilarity Assessment
Dec 16, 2015
byFiona M. Greer
Elucidation: Centers for the Innovation in Advanced Development and Manufacturing
Regulatory Affairs
Elucidation: Centers for the Innovation in Advanced Development and Manufacturing
Elucidation: Centers for the Innovation in Advanced Development and Manufacturing
Dec 16, 2015
+2
byMichael P. Angelastro, R. Thomas Warfand 2 more
Process economy and production capacity: Comparing single-use and stainless steel strategies for microbial fermentation
Sponsored Content
Process economy and production capacity: Comparing single-use and stainless steel strategies for microbial fermentation
Process economy and production capacity: Comparing single-use and stainless steel strategies for microbial fermentation
Dec 9, 2015
+2
byKenneth Clapp, Eva Lindskogand 2 more
From the Editor
Business
From the Editor November 2015
From the Editor November 2015
Nov 17, 2015
byS. Anne Montgomery
Spotlight
Business
Spotlight November 2015
Spotlight November 2015
Nov 17, 2015
byBPI Staff
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
Outsourcing Stability Testing: Discussions with Contract Laboratories
Formulation
Outsourcing Stability Testing: Discussions with Contract Laboratories
Outsourcing Stability Testing: Discussions with Contract Laboratories
Nov 17, 2015
byMaribel Rios
Next-Generation Bioprocessing for Meeting Healthcare Challenges: The Role Single-Use Handling Systems Can Play
Single Use
Next-Generation Bioprocessing for Meeting Healthcare Challenges: The Role Single-Use Handling Systems Can Play
Next-Generation Bioprocessing for Meeting Healthcare Challenges: The Role Single-Use Handling Systems Can Play
Nov 17, 2015
byWallace Wittkoff, John Boehm
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
CMC Forums
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
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Nov 17, 2015
byCheryl Scott
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Biosimilar Products: Scientific Principles,
Biosimilars
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Biosimilar Products: Scientific Principles, Challenges, and Opportunities
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Biosimilar Products: Scientific Principles, Challenges, and Opportunities
Nov 17, 2015
+2
byAnthony Ridgway, PhD, Nadine Ritterand 2 more
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining
QA/QC
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Nov 17, 2015
+3
byZiping Wei, Emily Shacterand 3 more
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized
QA/QC
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase, and Postapproval
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase, and Postapproval
Nov 17, 2015
byJohn Towns, Keith Webber
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and
Fill/Finish
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and Stability Testing
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and Stability Testing
Nov 17, 2015
+5
byNoel Rieder, Helene Gazzano-Santoroand 5 more
Quantitative Risk Assessment of Bioaccumulation Attributable to Extractables and Leachables in Cellular Immunotherapy Biomanufacturing
Cell Therapies
Quantitative Risk Assessment of Bioaccumulation Attributable to Extractables and Leachables in Cellular Immunotherapy Biomanufacturing
Quantitative Risk Assessment of Bioaccumulation Attributable to Extractables and Leachables in Cellular Immunotherapy Biomanufacturing
Nov 16, 2015
+2
byKevin Lannon, James A. Smithand 2 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
Ask the Expert: Taking Medium and Feed Development Beyond Maximizing Protein Titer to Optimizing Glycan Distribution and Simplifying Process Scale-Up
Sponsored Content
Ask the Expert: Taking Medium and Feed Development Beyond Maximizing Protein Titer to Optimizing Glycan Distribution and Simplifying Process Scale-Up
Ask the Expert: Taking Medium and Feed Development Beyond Maximizing Protein Titer to Optimizing Glycan Distribution and Simplifying Process Scale-Up
Nov 16, 2015
byBPI Staff
Spotlight
Business
Spotlight October 2015
Spotlight October 2015
Oct 15, 2015
byCheryl Scott
Effective Management of Contract Organizations: Keeping the Product Pipeline Moving, Compliant, and Available
Economics
Effective Management of Contract Organizations: Keeping the Product Pipeline Moving, Compliant, and Available
Effective Management of Contract Organizations: Keeping the Product Pipeline Moving, Compliant, and Available
Oct 15, 2015
+7
byAnthony Mire-Sluis, Julia Edwardsand 7 more
Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities
Single Use
Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities
Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities
Oct 15, 2015
byTony White, Kevin Ott
<b>Special Report:</b> Turning Discoveries into Products &mdash; Developability Assessments and Highly Efficient Process Design
Cell Line Development
Special Report: Turning Discoveries into Products — Developability Assessments and Highly Efficient Process Design
Special Report: Turning Discoveries into Products — Developability Assessments and Highly Efficient Process Design
Oct 15, 2015
byAngelo DePalma

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