Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
- Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
- A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
- The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
- This Industrial Fungus Has Protein Expression Promise For Pharma
- Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers
- High Specific Productivity For Leaner Sustainable Bioprocessing
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
GUEST COLUMNISTS
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Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
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A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.
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The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."
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This Industrial Fungus Has Protein Expression Promise For Pharma
Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.
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Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers
Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.
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High Specific Productivity For Leaner Sustainable Bioprocessing
Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.
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New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
BIOSIMILAR WHITE PAPERS
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Performance Characteristics Of The MobiusĀ® ADC Reactor For Conjugation
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
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Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection10/3/2024
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.
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2024 Global Biopharma Sustainability Review9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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Solve ATMP Aseptic Filling Challenges With Gloveless Isolators1/9/2026
Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.
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Process Analytical Technology In The ADC Bioconjugation Process4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
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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.
BIOSIMILAR APP NOTES & CASE STUDIES
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
- Zydus Launches Biosimilar Aflibercept 2 mg ANYRA For Advancing Ophthalmic Care
- Sandoz Receives US FDA Approval To Expand Enzeevu (aflibercept-abzv) Label For Multiple Retinal Indications
- FDA Approves FILKRI7™ (filgrastim-laha), Accord BioPharma's Biosimilar To NEUPOGEN® (filgrastim)
- U.S. FDA Clears IND For Phase 1 Study Of Henlius' Subcutaneous Daratumumab Biosimilar
- STADA And Bio-Thera Receive European Marketing Authorization For Gotenfia, A Biosimilar To Simponi
- Samsung Bioepis Reaches Settlement Agreement For Eylea (Aflibercept) Biosimilar In The United States
- AAM's John Murphy III Testifies Before Congress On Lowering Health Care Costs And The Prescription Drug Supply Chain
- Lotus Pharmaceutical Becomes Commercialization Partner For Formycon's Keytruda Biosimilar Candidate FYB206 Across Major Parts Of The Asia-Pacific Region
NEWSLETTER ARCHIVE
- 02.19.26 -- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- 02.12.26 -- Building Enterprise Resilience From QRM Signals
- 01.29.26 -- The Latest In Upstream HCP Mitigation
- 01.15.26 -- SUS Insufficient For 40% Of Biopharma
- 01.08.26 -- What 2025 FDA Warning Letters Tell Us About GMP Compliance