Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
- 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- FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK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
- 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
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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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FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK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.
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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.
BIOPROCESSING WHITE PAPERS
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Antibody-Based Drug Discovery At The Speed Of Light
Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.
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Modular Automation: The Plug-And-Produce Opportunity For Life Sciences2/12/2025
Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.
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Development And Regulation Of Veterinary Monoclonals2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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If You Can't Win The Game, Change It12/11/2024
Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.
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Driving Digital Excellence In Life Sciences7/1/2025
The life sciences industry is rapidly evolving through digital transformation and agility. Discover why embracing modern technologies is essential to thrive in today’s competitive landscape.
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Advancing QC Efficiency With SEC-MALS System And Empower Software7/31/2025
Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.
BIOPROCESSING APP NOTES & CASE STUDIES
- A Study To Assess Organoid Size And Cell Count From 3D Image Analysis
- High-Yield Expression Of Complex Proteins From Stable Pools
- How Pierre Fabre Laboratories Enhances Their Antibody Developability Platform
- Use Of 60 Micron Plastic (PE) Retention Filter For Perfusion Media Exchange
- Analyzing Biological Drug Effects In 3D
- 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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