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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Perfusion Cell Line Development For Intensified Processes
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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Business Continuity Management: The Benzonase® Endonuclease Success Story8/21/2024
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
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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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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.
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How Lipid Nanoparticles Enable Next-Gen Delivery10/20/2025
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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Why Choose Robotic Processing For Small Batch Aseptic Filling1/9/2026
Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.
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
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- 01.08.26 -- What 2025 FDA Warning Letters Tell Us About GMP Compliance