Process Development

regulatory approvals

Process Development

Process Development, Manufacturing, and Clinical Support for Bispecific Antibodies: Chemistry, Manufacturing, and Controls Considerations Process Development, Manufacturing, and Clinical Support for Bispecific Antibodies: Chemistry, Manufacturing, and Controls Considerations

+2

byYanhuai (Richard) Ding, Bruce Andrienand 2 more

Nov 15, 2024

innovation network/collaboration

Process Development

Driving Sustainability in Biologics Process Development: Innovative Strategies and Technologies Driving Sustainability in Biologics Process Development: Innovative Strategies and Technologies

byDavid Roush, Sri Madabhushi

Nov 14, 2024

A Scale-Up/-Down Platform for Fast-Paced Upstream Process Development of rAAV-Based Gene Therapies A Scale-Up/-Down Platform for Fast-Paced Upstream Process Development of rAAV-Based Gene Therapies

byTereza Pavlištová, Maria João Alves Correiaand 5 more

Oct 17, 2024

scientist in lab

Process Development

Safeguarding Bioproduction Modalities: Comprehensive Testing Strategies Require Reliable Analytical Processes and Reference Materials Safeguarding Bioproduction Modalities: Comprehensive Testing Strategies Require Reliable Analytical Processes and Reference Materials

byLeka Papazisi, Fang Tian

Oct 15, 2024

scientist assessing virus-filter integrity

Process Development

Influence of Air-Diffusion Value Shifts on Virus-Clearance Values: Safety Risk Assessment for Virus-Filter Integrity Testing in Multiround Housings Influence of Air-Diffusion Value Shifts on Virus-Clearance Values: Safety Risk Assessment for Virus-Filter Integrity Testing in Multiround Housings

byHyejee Jang, Lalit Saxenaand 3 more

Oct 15, 2024

Process Development

Benefits of Process Control for Combination Products: From Cost and Compliance to Unexpected Efficiencies Benefits of Process Control for Combination Products: From Cost and Compliance to Unexpected Efficiencies

Sep 20, 2024

Ingenza

Process Development

Bacillus subtilis: A Promising Microbial Host System for Efficient Recombinant-Protein Production

Bacillus subtilis: A Promising Microbial Host System for Efficient Recombinant-Protein Production

BPI Theater Panelists

Process Development

Driving Therapies Forward with the End Goal in Mind

Driving Therapies Forward with the End Goal in Mind

compass on a map

Process Development

Navigating the Commercial Cycle of Biologics Manufacturing

Navigating the Commercial Cycle of Biologics Manufacturing

byFilippo Pendin

PRI/HCP eBook cover wide

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eBook: Host Cell Proteins — Moving from Detection to Knowledge-Building

eBook: Host Cell Proteins — Moving from Detection to Knowledge-Building

+3

byDerrick Zhang, Shankar Sellappanand 3 more

Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor Cell Therapies: Part 1 — In-Process and Drug Product Control

Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor Cell Therapies: Part 1 — In-Process and Drug Product Control

byBrent Morse, Alicja Fiedorowicz

Monoclonal Antibody Productivity

A Fully Single-Use Downstream Process for Monoclonal Antibodies

A Fully Single-Use Downstream Process for Monoclonal Antibodies

+1

byShunsuke Shiina, Neha Saxenaand 1 more

hydrogels as cell encapsulants

Characterization of Hydrogel Carriers: Improving the Efficacy of Existing Cell Therapies

Characterization of Hydrogel Carriers: Improving the Efficacy of Existing Cell Therapies

+1

byStella Vnook, Megan Hamiltonand 1 more

integration of four deterministic lateral displacement (DLD) sorting arrays in parallel on a single chip

Microfluidic Cell Sorting: Scaling for Clinical and Therapeutic Applications

Microfluidic Cell Sorting: Scaling for Clinical and Therapeutic Applications

+1

byNicholas Tan Kwan Zen, Jongyoon Hanand 1 more

Process Development

Increased Productivity and Seamless Scalability: Advantages of an ATF System for Upstream Process Intensification

Increased Productivity and Seamless Scalability: Advantages of an ATF System for Upstream Process Intensification

byMuhammad Shamim

Bioreactor

Lessons in Bioreactor Scale-Up: Part 1 — Exploring Introductory Principles

Lessons in Bioreactor Scale-Up: Part 1 — Exploring Introductory Principles

byMuhammad Arshad Chaudhry

Host Cell Proteins — Bench to Production Solutions

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Host Cell Proteins — Bench to Production Solutions

Host Cell Proteins — Bench to Production Solutions

byBPI Contributor

Optimizing and Intensifying ADC Aggregate Removal: A DoE Approach to Membrane Chromatography and Rapid Cycling

Process Development

Optimizing and Intensifying ADC Aggregate Removal: A DoE Approach to Membrane Chromatography and Rapid Cycling

Optimizing and Intensifying ADC Aggregate Removal: A DoE Approach to Membrane Chromatography and Rapid Cycling

+3

byAudrey Bendelac, Timo Schmidbergerand 3 more

Deciphering Nutritional Needs in Bioprocess Optimization: Targeted and Untargeted Metabolomics with Genome-Scale Modeling

Process Development

Deciphering Nutritional Needs in Bioprocess Optimization: Targeted and Untargeted Metabolomics with Genome-Scale Modeling

Deciphering Nutritional Needs in Bioprocess Optimization: Targeted and Untargeted Metabolomics with Genome-Scale Modeling

+1

byCecilia Socolsky, William G. Whitfordand 1 more

Overcoming the Productivity Bottleneck in MAb Capture

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Overcoming the Productivity Bottleneck in MAb Capture

Overcoming the Productivity Bottleneck in MAb Capture

+1

byMario Grünberg, Kim Beatrice Kuchemüllerand 1 more

Enabling Next-Generation Biomanufacturing Using Cell-Free Technology

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Enabling Next-Generation Biomanufacturing Using Cell-Free Technology

Enabling Next-Generation Biomanufacturing Using Cell-Free Technology

byBPI Contributor

Hardware, Software, and Wetware: 20 Years of Advancements in Biopharmaceutical Production, Part 1

Hardware, Software, and Wetware: 20 Years of Advancements in Biopharmaceutical Production, Part 1

Hardware, Software, and Wetware: 20 Years of Advancements in Biopharmaceutical Production, Part 1

byYuval Shimoni, Cheryl Scott

Host-Cell Protein Analytics: History and Future Trends

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Host-Cell Protein Analytics: History and Future Trends

Host-Cell Protein Analytics: History and Future Trends

Transfection: Past, Present, and Future

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Transfection: Past, Present, and Future

Transfection: Past, Present, and Future

byMiguel Dominguez

Host Cell Protein Analysis: Immunoassays and Orthogonal Characterization By Antibody Affinity Extraction and Mass Spectrometry Methods

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Host Cell Protein Analysis: Immunoassays and Orthogonal Characterization By Antibody Affinity Extraction and Mass Spectrometry Methods

Host Cell Protein Analysis: Immunoassays and Orthogonal Characterization By Antibody Affinity Extraction and Mass Spectrometry Methods

+3

byAlla Zilberman, Kerry Woodingand 3 more

Plant-Based Protein Expression: Emerging Systems Bring Viable Approaches to Biopharmaceutical Manufacturing

Expression Platforms

Plant-Based Protein Expression: Emerging Systems Bring Viable Approaches to Biopharmaceutical Manufacturing

Plant-Based Protein Expression: Emerging Systems Bring Viable Approaches to Biopharmaceutical Manufacturing

+1

byDoug Cossar, Michael D. McLeanand 1 more

Reducing Downstream Scale-Up Needs: Advances Toward Continuous Downstream Processing

Process Development

Reducing Downstream Scale-Up Needs: Advances Toward Continuous Downstream Processing

Reducing Downstream Scale-Up Needs: Advances Toward Continuous Downstream Processing

byBrian Gazaille, Margit Holzer

Scaling AAV Production: Easing the Transition from Laboratory Scales to Commercial Manufacturing

Process Development

Scaling AAV Production: Easing the Transition from Laboratory Scales to Commercial Manufacturing

Scaling AAV Production: Easing the Transition from Laboratory Scales to Commercial Manufacturing

byBrian Gazaille, Barbara Kraus

Mind the Gap: Managing Relationships Between Upstream and Downstream Intensification

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Mind the Gap: Managing Relationships Between Upstream and Downstream Intensification

Mind the Gap: Managing Relationships Between Upstream and Downstream Intensification

byPriyanka Gupta, Katy McLaughlin

Bench to Bedside: Why Successful Drug Development Requires a Team Approach

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Bench to Bedside: Why Successful Drug Development Requires a Team Approach

Bench to Bedside: Why Successful Drug Development Requires a Team Approach

Posttranslational Modifications and Their Control in CHO Culture

Expression Platforms

Posttranslational Modifications and Their Control in CHO Culture

Posttranslational Modifications and Their Control in CHO Culture

+1

byYixiao Zhang, Zhimei Duand 1 more

Analyzing Single-Use Polymers for Cell Culture Processes: Comparison of Cell Growth and Viability Test Procedures

Process Development

Analyzing Single-Use Polymers for Cell Culture Processes: Comparison of Cell Growth and Viability Test Procedures

Analyzing Single-Use Polymers for Cell Culture Processes: Comparison of Cell Growth and Viability Test Procedures

+4

byJennifer Kneitz, Maximilian Rotterand 4 more

Gain Control of Culture Conditions: Technology for Sustained Delivery of Recombinant Proteins

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Gain Control of Culture Conditions: Technology for Sustained Delivery of Recombinant Proteins

Gain Control of Culture Conditions: Technology for Sustained Delivery of Recombinant Proteins

byPamela De Lacy, Sally Temple

Sponsored Content

Ask the Expert: HCP Analysis By Orthogonal Methods in Vaccine and Gene Therapy Development

Ask the Expert: HCP Analysis By Orthogonal Methods in Vaccine and Gene Therapy Development

byBPI Contributor

Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform

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Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform

Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform