The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.
- Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
- A Hierarchy of Metrics Brings Strategy Into Biopharma's Daily Work
- An End-To-End Automated HTP Platform For Cell Line Optimization
- Here's What You Need To Know About The Access Consortium Pathway
- FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK
- 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
EDITOR'S DESK
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AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.
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.
GUEST COLUMNISTS
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Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
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A Hierarchy of Metrics Brings Strategy Into Biopharma's Daily Work
Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.
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An End-To-End Automated HTP Platform For Cell Line Optimization
Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.
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Here's What You Need To Know About The Access Consortium Pathway
Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.
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FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK
The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.
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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.
BIOPROCESSING WHITE PAPERS
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A Comparative Analysis Between Liquid Nitrogen And Mechanical Freezers
Explore the differences between liquid nitrogen and mechanical cryogenic freezers, and learn how each method supports scientific, medical, and industrial storage needs.
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Leveraging Life Sciences Data For Intelligent Decision-Making2/18/2025
Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing2/9/2024
Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.
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Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability10/16/2024
Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.
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Overcoming Challenges To High-Concentration Formulation Development3/25/2025
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
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Is Sustainability The Key To Agile Biopharma Manufacturing?3/18/2025
In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
BIOPROCESSING APP NOTES & CASE STUDIES
- Developing A Project Management Office (PMO) At A Small Manufacturing Site
- Enhanced Structural Characterization Of Thermal Unfolding With MMS
- Real-Time Growth Monitoring Of Spheroids In Round Bottom Microplates
- Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer
- Exosome Isolation By TFF And Size Exclusion Chromatography
- 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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- mAb Purification: A Two-Step Approach Using A Strong AEX-HIC Mixed-Mode Resin
- Streamlining pDNA: Capacity, Complexity, And Cutting-Edge Solutions
- Are You Keeping Pace With Oligo Synthesis Optimization?
- From Readiness To Results: Unlocking Capacity For Expanding Product Demand
- Accelerating Early Phase Biologics From The Clinic To Commercialization
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 11.25.25 -- Improving Sponsor–CMO Collaboration Around Digital Deviations
- 11.24.25 -- Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach
- 11.21.25 -- STREAM Edition: Developing Analytical Methods For Advanced ADCs
- 11.21.25 -- It's Not Just You, Everyone's Talking About OPV
- 11.20.25 -- Manufacturing Breakthroughs: γδ T Cells, CAR-T Automation, T Cell Expansion Solutions