Therapeutic Modalities

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

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byNaveenganesh Muralidharan

Apr 20, 2023

Strengthening Data Management and Integrity for CGT Applications

Strengthening Data Management and Integrity for CGT Applications Strengthening Data Management and Integrity for CGT Applications

Apr 20, 2023

Purification of Hepatitis B Virus Surface Antigen for Vaccine Products: Impact of Ligand Density on HBsAg Purification By Immunoaffinity

Purification of Hepatitis B Virus Surface Antigen for Vaccine Products: Impact of Ligand Density on HBsAg Purification By Immunoaffinity Chromatography Purification of Hepatitis B Virus Surface Antigen for Vaccine Products: Impact of Ligand Density on HBsAg Purification By Immunoaffinity Chromatography

byMayté Quintana, Williams Ferroand 6 more

Mar 21, 2023

Advances Toward Dry-Powder Formulations for Monoclonal Antibodies

Advances Toward Dry-Powder Formulations for Monoclonal Antibodies Advances Toward Dry-Powder Formulations for Monoclonal Antibodies

byBrian Gazaille, Robert O. Williams III

Mar 21, 2023

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

Mar 21, 2023

Meeting the Unique Needs of Rare-Disease Patients

Meeting the Unique Needs of Rare-Disease Patients Meeting the Unique Needs of Rare-Disease Patients

Mar 21, 2023

eBook: Monoclonal Antibodies — Reviewing the Past Year in Design, Engineering, Characterization, Manufacturing, and Formulation

eBook: Monoclonal Antibodies — Reviewing the Past Year in Design, Engineering, Characterization, Manufacturing, and Formulation

eBook: Monoclonal Antibodies — Reviewing the Past Year in Design, Engineering, Characterization, Manufacturing, and Formulation

The Next Frontier for Viral-Vector Vaccines: Considerations for Manufacturing and Operations

The Next Frontier for Viral-Vector Vaccines: Considerations for Manufacturing and Operations

The Next Frontier for Viral-Vector Vaccines: Considerations for Manufacturing and Operations

byBrian Gazaille, Stefano Colloca

SARS-CoV-2 Variants: A Case for Expanding mRNA Vaccine Production Globally

SARS-CoV-2 Variants: A Case for Expanding mRNA Vaccine Production Globally

SARS-CoV-2 Variants: A Case for Expanding mRNA Vaccine Production Globally

byMahesh Bhalgat

Leishmaniasis — a Forgotten Epidemic

Leishmaniasis — a Forgotten Epidemic

Leishmaniasis — a Forgotten Epidemic

+4

byFlavia D'Alessio, Sophie Houardand 4 more

Water-Proton Nuclear Magnetic Resonance Spectroscopy: Emerging Applications for Vaccine Quality Assessment

Water-Proton Nuclear Magnetic Resonance Spectroscopy: Emerging Applications for Vaccine Quality Assessment

Water-Proton Nuclear Magnetic Resonance Spectroscopy: Emerging Applications for Vaccine Quality Assessment

byBrian Gazaille, Marc B. Taraban

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

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Less Is More in mRNA Therapeutics: Developing Big Ideas at Small Scales

Less Is More in mRNA Therapeutics: Developing Big Ideas at Small Scales

byLinda Mathiasson

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

+5

byBrian Gazaille, Joseph B. Lillegardand 5 more

January-February 2023 Featured Report

January-February 2023 Featured Report

January-February 2023 Featured Report

eBook: mRNA — Negotiating New Manufacturing Hurdles

eBook: mRNA — Negotiating New Manufacturing Hurdles

eBook: mRNA — Negotiating New Manufacturing Hurdles

+2

byJake Adams, Dan Stantonand 2 more

Cell Therapy — Supply Chain Discussions

Cell Therapy — Supply Chain Discussions

Cell Therapy — Supply Chain Discussions

+3

byDan Stanton, Gareth Macdonaldand 3 more

Improving Scalability of AAV and Lentivirus Production: Tailored Transfection Reagents Enable Large-Scale Manufacturing

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Improving Scalability of AAV and Lentivirus Production: Tailored Transfection Reagents Enable Large-Scale Manufacturing

Improving Scalability of AAV and Lentivirus Production: Tailored Transfection Reagents Enable Large-Scale Manufacturing

byMiguel Dominguez

Using Synthetic Biology To Develop Novel Biotherapeutics

Emerging Therapeutics

Using Synthetic Biology To Develop Novel Biotherapeutics

Using Synthetic Biology To Develop Novel Biotherapeutics

byDavid L. Hava

Purity by Design

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Purity by Design

Purity by Design

+4

byTerry Pizzie, Sujeong Yangand 4 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

Cell-Free Synthesis of Highly Potent Recombinant Neurotoxins: A Process Economic Feasibility Study

Emerging Therapeutics

Cell-Free Synthesis of Highly Potent Recombinant Neurotoxins: A Process Economic Feasibility Study

Cell-Free Synthesis of Highly Potent Recombinant Neurotoxins: A Process Economic Feasibility Study

+2

byWilliams Olughu, Christos Stamatisand 2 more

Allogeneic Cell Therapy Manufacturing: Preparing for Tomorrow’s Success

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Allogeneic Cell Therapy Manufacturing: Preparing for Tomorrow’s Success

Allogeneic Cell Therapy Manufacturing: Preparing for Tomorrow’s Success

Streamlining Vaccine Process Characterization Using an Automated Reactor System

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Streamlining Vaccine Process Characterization Using an Automated Reactor System

Streamlining Vaccine Process Characterization Using an Automated Reactor System

byKyle Deluca, Felix Milman

Addressing Challenges in Analyzing Heterogeneous AAV Populations

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Addressing Challenges in Analyzing Heterogeneous AAV Populations

Addressing Challenges in Analyzing Heterogeneous AAV Populations

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bySvea Cheeseman, Paul Gettyand 1 more

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

Cell and gene therapy regulations moving in right direction says ARM

Therapeutic Modalities

Cell and gene therapy regulations moving in right direction says ARM

Cell and gene therapy regulations moving in right direction says ARM

byGareth Macdonald

eBook: Vaccines — From Disease Prevention to Treatment

Therapeutic Class

eBook: Vaccines — From Disease Prevention to Treatment

eBook: Vaccines — From Disease Prevention to Treatment

byDan Stanton, Millie Nelson

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

Harnessing the Untapped Power of the Human Commensal Virome

Personalized Medicine

Harnessing the Untapped Power of the Human Commensal Virome

Harnessing the Untapped Power of the Human Commensal Virome

Optimize Your Early Preclinical Process for Gene Therapy Success

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Optimize Your Early Preclinical Process for Gene Therapy Success

Optimize Your Early Preclinical Process for Gene Therapy Success

byKatie Roberts

Addressing Unwanted Immunogenicity in Gene Therapies

Addressing Unwanted Immunogenicity in Gene Therapies

Addressing Unwanted Immunogenicity in Gene Therapies

byCarsten Brunn, Kei Kishimoto

Building Manufacturing Capabilities for Adenoassociated Virus Vectors: Key Considerations for Facility Design and Operations

Facility Design/Engineering

Building Manufacturing Capabilities for Adenoassociated Virus Vectors: Key Considerations for Facility Design and Operations

Building Manufacturing Capabilities for Adenoassociated Virus Vectors: Key Considerations for Facility Design and Operations

byBrian Gazaille, Curran Simpson

Effective Processing of Lentiviral Vectors: Introducing a Paradigm-Shifting Technology

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Effective Processing of Lentiviral Vectors: Introducing a Paradigm-Shifting Technology

Effective Processing of Lentiviral Vectors: Introducing a Paradigm-Shifting Technology

+1

byIan Scanlon, Sujeong Yangand 1 more

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