An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
- A Gentler Cell Line Selection Method Using microRNA
- Controls For Retrieval-Augmented Generation In GxP
- Implementing AI Solutions In GMP While Managing Risk
- Implementing And Optimizing Your eQMS
- A Much-Improved Approach For Understanding And Managing Safety Risks
- CSV Assumes The AI System Sits Still — It Doesn't.
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
GUEST COLUMNISTS
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A Gentler Cell Line Selection Method Using microRNA
Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.
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Controls For Retrieval-Augmented Generation In GxP
Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.
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Implementing AI Solutions In GMP While Managing Risk
When using artificial intelligence in GMP settings, risk management extends far beyond validation. This discussion explores moving AI solutions out of the pilot phase.
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Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
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A Much-Improved Approach For Understanding And Managing Safety Risks
Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.
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CSV Assumes The AI System Sits Still — It Doesn't.
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
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July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
BIOSIMILAR WHITE PAPERS
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Biopharma Supply, Reimagined: Regional, Resilient Manufacturing
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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Perfusion Cell Line Development For Intensified Processes5/5/2025
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing6/13/2025
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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A Comprehensive Solution For Adventitious Agent Testing2/13/2026
Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.
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Innovation In Filtration3/18/2025
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
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Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators4/28/2025
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
BIOSIMILAR APP NOTES & CASE STUDIES
- How To Successfully Isolate Your T Cells
- Non Animal Origin Squalene For High-Risk Applications
- Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing
- Implementation Of Multi-Column Chromatography Systems
- Microbial Recovery And Flow Performance With Membranes
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Biocon's Pertuzumab Becomes First Biosimilar To Secure EMA CHMP Approval Recommendation Under New Tailored Clinical Approach
- Sandoz Announces Collaboration With mAbxience To Expand Patient Access To Life-Enhancing Biosimilar Medicines
- Henlius HANDAYUAN Received DRAP Approval In Pakistan
- Shilpa Biologicals And SPIMACO Bio Sign Strategic License Agreement For PD-1 Biosimilar For MENA Market
- Dr. Reddy's Laboratories Launches NIVORZ (Nivolumab Biosimilar) In India
- Bio Usawa And Axmed Partner To Expand Access To Affordable Biologic Medicines Across Africa
- Indian Pharmacopoeia Commission (IPC) Organizes National Conference On Quality And Safety Of Biosimilars: Strengthening India's Biopharma SHAKTI Vision
- U.S. Generic & Biosimilar Medicines Save $496B In Just 1 Year
NEWSLETTER ARCHIVE
- 09.17.26 -- Your Collaborator: mAb Productivity And Robustness
- 09.17.26 -- A Much-Improved Approach For Managing Safety Risks
- 09.16.26 -- Smarter Ways To Reduce Risk, Downtime, And Lifecycle Surprises
- 09.10.26 -- U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
- 09.03.26 -- Why Trusted Data Is A Process Variable in Bioprocessing