Cell Therapies

Analytical Method Validation Challenges for Advanced Therapies: Using Gene Therapies as an Example

Analytical Method Validation Challenges for Advanced Therapies: Using Gene Therapies as an Example Analytical Method Validation Challenges for Advanced Therapies: Using Gene Therapies as an Example

Due to novelty and complexity in molecular characteristics and manufacturing, validation of analytical methods for ATMPs can be challenging.

byPatrick Nieuwenhuizen, Christopher Rogers

Oct 20, 2023

eBook: Viral Vectors — Progress Toward Production Platforms

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eBook: Viral Vectors — Progress Toward Production Platforms eBook: Viral Vectors — Progress Toward Production Platforms

byBrian Gazaille

Aug 29, 2023

How Emerging Technology Is Improving the Cell Therapy Manufacturing Landscape

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How Emerging Technology Is Improving the Cell Therapy Manufacturing Landscape How Emerging Technology Is Improving the Cell Therapy Manufacturing Landscape

byBPI Contributor

Aug 21, 2023

BioProcess Insider Interview: Luis Berrade, Senior Director, Biologics Testing Solutions, Charles River Laboratories

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BioProcess Insider Interview: Luis Berrade, Senior Director, Biologics Testing Solutions, Charles River Laboratories BioProcess Insider Interview: Luis Berrade, Senior Director, Biologics Testing Solutions, Charles River Laboratories

byBPI Contributor

Aug 21, 2023

Improving AAV Manufacturing Processes: Using Design of Experiments and Fit-for-Purpose Transfection Reagents

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Improving AAV Manufacturing Processes: Using Design of Experiments and Fit-for-Purpose Transfection Reagents Improving AAV Manufacturing Processes: Using Design of Experiments and Fit-for-Purpose Transfection Reagents

byPaul Giroud, Hakima Flici

Jul 20, 2023

Xeno-free T cell Expansions in PBS Mini Vertical-Wheel® Bioreactor Using CellGenix® reagents

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Xeno-free T cell Expansions in PBS Mini Vertical-Wheel® Bioreactor Using CellGenix® reagents Xeno-free T cell Expansions in PBS Mini Vertical-Wheel® Bioreactor Using CellGenix® reagents

byBPI Contributor

Jun 29, 2023

1 Min Read

Measurement of Particulates in Single-Use Systems for Cell and Gene Therapies Manufacturing — Part 1: Misapplication of USP <788>

Cell Line Development

Measurement of Particulates in Single-Use Systems for Cell and Gene Therapies Manufacturing — Part 1: Misapplication of USP <788>

Measurement of Particulates in Single-Use Systems for Cell and Gene Therapies Manufacturing — Part 1: Misapplication of USP <788>

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byJames D. Vogel, Andreas Hohenleutnerand 2 more

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Introducing a Stable Producer Cell Line for Large-Scale AAV Manufacturing

Introducing a Stable Producer Cell Line for Large-Scale AAV Manufacturing

byDovile Gruzdyte

eBook: Perspectives on CAR-T Cell Therapy

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eBook: Perspectives on CAR-T Cell Therapy

eBook: Perspectives on CAR-T Cell Therapy

byDan Stanton, Managing editor

Using Regulatory T Cells for Treatment of Type 1 Diabetes, Part 2: Drug Development and the Transition to Clinical Trials

Using Regulatory T Cells for Treatment of Type 1 Diabetes, Part 2: Drug Development and the Transition to Clinical Trials

Using Regulatory T Cells for Treatment of Type 1 Diabetes, Part 2: Drug Development and the Transition to Clinical Trials

byJosh Abbott, Leonardo Ferreira

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

Viral Clearance

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

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byDavid Perez-Caballero, David Murrayand 2 more

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

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Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

byBPI Contributor

Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

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Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

byBPI Contributor

Quantitative Risk Assessment of Limits for Residual Host-Cell DNA: Ensuring Patient Safety for In Vitro Gene Therapies Produced Using Human-Derived

Quantitative Risk Assessment of Limits for Residual Host-Cell DNA: Ensuring Patient Safety for In Vitro Gene Therapies Produced Using Human-Derived Cell Lines

Quantitative Risk Assessment of Limits for Residual Host-Cell DNA: Ensuring Patient Safety for In Vitro Gene Therapies Produced Using Human-Derived Cell Lines

byNaveenganesh Muralidharan

Strengthening Data Management and Integrity for CGT Applications

Strengthening Data Management and Integrity for CGT Applications

Cryopreserving Hematopoietic Stem Cells — Part 2: Methods, Materials, and Operations

Cryopreserving Hematopoietic Stem Cells — Part 2: Methods, Materials, and Operations

Cryopreserving Hematopoietic Stem Cells — Part 2: Methods, Materials, and Operations

byBrian Gazaille, Erik Woods

Meeting the Unique Needs of Rare-Disease Patients

Meeting the Unique Needs of Rare-Disease Patients

Overcoming AAV Manufacturing Challenges: Movement Toward Plug-and-Play Solutions

Overcoming AAV Manufacturing Challenges: Movement Toward Plug-and-Play Solutions

Overcoming AAV Manufacturing Challenges: Movement Toward Plug-and-Play Solutions

eBook: Cell Therapy — Lessons Learned from Working with Vectors and Cells

eBook: Cell Therapy — Lessons Learned from Working with Vectors and Cells

eBook: Cell Therapy — Lessons Learned from Working with Vectors and Cells

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byBrian Gazaille, Joseph B. Lillegardand 5 more

From Concept to Cure: Using AAV in Gene Therapy

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From Concept to Cure: Using AAV in Gene Therapy

From Concept to Cure: Using AAV in Gene Therapy

byBPI Contributor

Leading Biopharma Uses Linkit® AX: Here are the Results

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Leading Biopharma Uses Linkit® AX: Here are the Results

Leading Biopharma Uses Linkit® AX: Here are the Results

byBPI Contributor

eBook: Cryopreservation — Special Considerations for Cell Therapies

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eBook: Cryopreservation — Special Considerations for Cell Therapies

eBook: Cryopreservation — Special Considerations for Cell Therapies

byBrian Gazaille, Erik Woods

Resource Roadmap to Screening Success: Cell-based Therapy Edition

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Resource Roadmap to Screening Success: Cell-based Therapy Edition

Resource Roadmap to Screening Success: Cell-based Therapy Edition

byBPI Contributor

Addressing Unwanted Immunogenicity in Gene Therapies

Addressing Unwanted Immunogenicity in Gene Therapies

Addressing Unwanted Immunogenicity in Gene Therapies

byCarsten Brunn, Kei Kishimoto

Why Cell Manufacturing Matters: How Bioprocess Innovations Have Laid the Foundation for a Cell-Based Products Revolution

Why Cell Manufacturing Matters: How Bioprocess Innovations Have Laid the Foundation for a Cell-Based Products Revolution

Why Cell Manufacturing Matters: How Bioprocess Innovations Have Laid the Foundation for a Cell-Based Products Revolution

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byJon A. Rowley, Michael Boychynand 1 more

A Plug-and-Produce GMP Plant for Cell and Gene Therapies Part 2: Rapid Deployment of a Commercial-Scale Facility

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A Plug-and-Produce GMP Plant for Cell and Gene Therapies Part 2: Rapid Deployment of a Commercial-Scale Facility

A Plug-and-Produce GMP Plant for Cell and Gene Therapies Part 2: Rapid Deployment of a Commercial-Scale Facility

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byStefan Robert Kappeler, Gordon Nicholsonand 2 more

Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality

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Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality

Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality

byBPI Contributor

Revolutionizing Cell Culture with Cryopreserved Pre-Plated Cell Monolayers

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Revolutionizing Cell Culture with Cryopreserved Pre-Plated Cell Monolayers

Revolutionizing Cell Culture with Cryopreserved Pre-Plated Cell Monolayers

byBPI Contributor

Deriving Mesenchymal Stromal Cells from Umbilical Cord Lining and Wharton’s Jelly: A Comparative Study of Extraction Methods and Culture Media

Deriving Mesenchymal Stromal Cells from Umbilical Cord Lining and Wharton’s Jelly: A Comparative Study of Extraction Methods and Culture Media

Deriving Mesenchymal Stromal Cells from Umbilical Cord Lining and Wharton’s Jelly: A Comparative Study of Extraction Methods and Culture Media

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byKenny P.Y. Boey, Chee Tian Ongand 7 more

Increasing the Efficacy and Impact of Cell and Gene Therapies

Increasing the Efficacy and Impact of Cell and Gene Therapies

Increasing the Efficacy and Impact of Cell and Gene Therapies

bySusan Nichols

eBook: Factors Affecting Scalability of Cell Therapies

eBook: Factors Affecting Scalability of Cell Therapies

eBook: Factors Affecting Scalability of Cell Therapies

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byBrian Gazaille, Miguel Forteand 1 more

Application Note: Early-Stage Process Optimization for Seamless Scaling of MSC Therapies

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Application Note: Early-Stage Process Optimization for Seamless Scaling of MSC Therapies

Application Note: Early-Stage Process Optimization for Seamless Scaling of MSC Therapies

Hurdles Ahead for Cell and Gene Therapy Makers

Hurdles Ahead for Cell and Gene Therapy Makers

Hurdles Ahead for Cell and Gene Therapy Makers

byRobert Salcedo, Will Rosellini

Novel Technologies for Advancing Allogeneic Cell Therapies

Novel Technologies for Advancing Allogeneic Cell Therapies

Novel Technologies for Advancing Allogeneic Cell Therapies

byErin Kimbrel, Gary Starling

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

Process Intelligence: Gene Therapy Case Study Shows That the Journey to Improved Capabilities Starts with One Step

byDermot McCaul

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