Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.
- Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
- AI Is Not The CMC Revolution You're Looking For, And That's OK
- Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development
- How To Improve Sponsor–CMO Collaboration Around Digital Deviations
- Solving The Stem Cell Consistency Conundrum With iMSCs
- Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach
- Exploring The Benefits Of Electroporation In NK Cell Transfection
EDITOR'S DESK
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On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.
Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.
DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.
Nobel laureate, David Baltimore passed away at 87 years old, on September 6, 2025. He was widely regarded as a scientific visionary who at just 37, co-discovered reverse transcriptase, an enzyme that flipped molecular biology on its head by showing that genetic information could flow from RNA back to DNA, not just the other way around.
During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.
GUEST COLUMNISTS
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Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
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AI Is Not The CMC Revolution You're Looking For, And That's OK
Advanced therapy development today is less about big funding, more about frugality. Artificial intelligence unlocks a competitive advantage.
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Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development
The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
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How To Improve Sponsor–CMO Collaboration Around Digital Deviations
Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.
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Solving The Stem Cell Consistency Conundrum With iMSCs
The ability to produce unlimited batches of induced mesenchymal stem cells from a single iPSC cell bank is, perhaps, one of their most alluring features.
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Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach
Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.
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Exploring The Benefits Of Electroporation In NK Cell Transfection
Electroporation creates temporary holes in cell membranes for genetic material to slip through. The technique offers some key advantages to viral transduction.
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On The Potency Assurance Journey, Travelers Need A Road Map
When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.
BIOPROCESSING WHITE PAPERS
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Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells
Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.
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Best Practices In Commissioning And Qualification7/5/2024
An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
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Ready To Demystify Organoids?7/1/2025
Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
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Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration7/7/2025
Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
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Innovation And Evolution Of Affinity Chromatography Resins For Monoclonal Antibody Purification9/30/2025
Discover how innovations in ligand design and resin manufacturing have improved monoclonal antibody purification by enhancing selectivity, stability, and process economics.
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Scaling Up Viral Vector Harvest With Ease And Regulatory Compliance4/11/2025
Explore how scalable, high-performance solutions can help you overcome the challenges of large-volume viral vector production and accelerate the delivery of life-changing gene therapies.
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- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- Supporting The Next Generation Of ADCs
- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
- On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
- On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing
- On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.
- Single-Use Standardization Starts At Home
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.
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