Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.
- Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
- On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle
- BIO 2026: Modernizing The FDA And Bolstering The Workforce
- Transforming Computer System Validation In The Life Sciences Industry
- BIO 2026: Crowley On Competing With China And Modernizing The FDA
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
EDITOR'S DESK
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Essential CMC Elements For A Therapeutic Secretome
Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.
This article summarizes the major developments and industry pressures highlighted by Life Science Connect editors in the "Better Biopharma" midyear editorial roundtable.
Bioprocess Online's Editorial Advisory Board responds to former FDA commissioner Marty Makary’s resignation amid a prolonged period of instability at the agency.
Audience polls and expert insights reveal insufficient vendor data as the main bottleneck stalling advanced single-use technology adoption. Explore that and other key takeaways in this recap of the Bioprocess Online Live event on "Closing The Adoption Gap For Advanced Single-Use Materials."
Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.
GUEST COLUMNISTS
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Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.
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Top 5 Challenges In Antibody-Oligonucleotide Manufacturing
AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.
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Transforming Computer System Validation In The Life Sciences Industry
Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.
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Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
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Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.
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An Open-Source Modeling Tool For Suspended Continuous Lyophilization
Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.
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Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.
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How To Avoid The Biggest USP <665> Compliance Trap
U.S. Pharmacopeia General Chapter <665> went into effect May 1. One expert explains why complex bioprocessing equipment trains present a greater obstacle than you might think.
BIOPROCESSING WHITE PAPERS
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Three Key Actions To Minimize Dead Volumes
Minimizing liquid dead volume helps labs conserve costly reagents and scarce samples while boosting assay throughput. Learn how advanced liquid level detection technologies are driving efficiency.
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Why Pharmaceutical Scientists Trust The Discovery Core Rheometer5/1/2026
Drug formulations demand more than single‑point viscosity data. Explore how rheology reveals stability, flow, and structural behavior across suspensions, topicals, and injectables.
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Three Key Strategies To Guide Efficient And Effective Recall Management2/18/2025
Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.
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Advancing Chronic Care Through GLP‑1 Innovation1/23/2026
GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.
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End-To-End Process Scalability Of HEK 293 Media For High Titer AAV Production6/2/2026
Explore how controlled bioreactor environments enable optimization of critical process parameters and support robust, scalable AAV production from development through manufacturing.
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How To Take Your Process To A Closed System4/22/2025
Understand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.
BIOPROCESSING APP NOTES & CASE STUDIES
- Sample Preparation Automation For Immunosuppressant Drug Analysis
- Application Of A Dual Spiking Strategy In Viral Clearance Studies
- Facilitating Efficient Clone Selection And Enabling High-Throughput Clarification And Purification Processes
- Characterization Of Antibody-Drug Conjugate Critical Quality Attributes
- Assessing Viability And Real-Time Apoptosis/Necrosis
- On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle
- BIO 2026: Modernizing The FDA And Bolstering The Workforce
- BIO 2026: Crowley On Competing With China And Modernizing The FDA
- Essential CMC Elements For A Therapeutic Secretome
- Midyear Pulse Check: What's Shaping Biopharma In 2026?
- Reflecting On Continued Turbulence At The FDA
- Insufficient Vendor Data Is Hamstringing Single-Use Adoption
BIOPROCESS ONLINE CONTENT COLLECTIONS
This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Leveraging 3Rs For Superior Cell Line Characterization
- Release, Redefined: QC Testing Across In Vivo And Ex Vivo CAR-T
- Modular vs Flexible Aseptic Filling Lines: Impacts On Speed, Changeovers, And Scale
- Lyophilization Excellence: Partnering For Sterile Fill/Finish Success
- Next-Generation Filtration For Enhanced Capacity And Sustainability
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 07.17.26 -- STREAM Edition: Using Better Tools And Better Data To Drive Process Productivity
- 07.17.26 -- Cell Therapy Without The Cells: Building A Therapeutic Secretome With Noveome Biotherapeutics' Larry Brown, Sc.D.
- 07.16.26 -- The Facility Master Planning Playbook With Herman Bozenhardt
- 07.15.26 -- New Thought Leadership: AI, ADCs, Cell Therapy, And The Future Of Bioprocessing
- 07.15.26 -- The Scale-Up Risk Many Advanced Therapy Teams Overlook