FEATURE ARTICLES
The wrong regulatory filing sequence can close faster pathways, delay importation, and consume shelf life. Here’s how regulatory strategy can reshape clinical supply.
- AI Fills The Decision-Making Gaps In Process Analytical Technology
- Why Supplier Diversification Doesn't Ensure Supply Safety
- Oral Combination Therapies: Navigating Development Complexities
- Building Trust In AI For Computerized System Validation
- When To Trust And When To Verify AI-Enabled Validation Systems
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- Using Digital Platforms To Find Your CDMO
PHARMA ONLINE WHITE PAPERS
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![GettyImages-2184018692-adhesive-mixing]( "Mixing Technologies For The Production Of Low To High Viscosity Adhesives")
Mixing Technologies For The Production Of Low To High Viscosity AdhesivesUnderstand how high shear and planetary mixing technologies optimize adhesive production. Learn to reduce cycle times, eliminate defects, and balance efficiency with your specific viscosity needs.
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Isolators For Pharmacy Compounding – Time For Change?3/14/2025
Maintaining a contamination-free environment is crucial in drug compounding. Learn how isolator systems can improve safety, efficiency, and regulatory compliance.
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Navigating Complex OSD Challenges With Predictive Insights7/20/2026
Learn how predictive modeling, advanced material characterization, and data-driven process insights support manufacturing readiness and confident launch decisions.
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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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Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes4/8/2025
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
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Lessons Learned From Containment Performance Verification Activities7/24/2026
Ensure containment performance during active powder handling. Discover how human factors and airflow dynamics influence downflow booth protection.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation System
- Consistent Improvement In CHO-K1 GS Performance With Efficient-Pro Feed 3 And Efficient-Pro Feed Enhancer
- Producing Quality APIs At Scale
- Predicting Food Effects In Oral Drug Delivery Using PBPK Modeling
- QC In The Whole Genome Sequencing Library Preparation Workflow
NEWSLETTER ARCHIVE
- 09.21.26 -- Reducing Risk Across The Pharma Supply Chain
- 09.19.26 -- Packaging And Inspection Product Showcase
- 09.18.26 -- When To Trust And When To Verify AI-Enabled Validation Systems
- 09.17.26 -- How Leading Teams Reduce Risk And Improve Readiness
- 09.17.26 -- Controls For Retrieval-Augmented Generation In GxP
INDUSTRY NEWS
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![white coupon banner, great topic-GettyImages-2271702407]( "Let Your Voice Help Shape Pharma Manufacturing")
Let Your Voice Help Shape Pharma ManufacturingPharmaceutical Online hosts live virtual panels with industry experts on important topics and challenges, and we want to know what topics are important to you. Please consider taking a few minutes of your time to tell us what they are.
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![rating service, satisfaction-GettyImages-2221603596]( "ISPE Announces 2026 FOYA Winners")
ISPE Announces 2026 FOYA WinnersThese awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
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![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.
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![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.
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![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough North America led the market with a 38.32% market share of $3.15 billion in 2024, Asia Pacific is expected to have the fastest growth in the upcoming years.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Explore how sterility assurance, including sterilization validation and environmental monitoring, is essential for controlling microbial contamination in mammalian cell production to ensure patient safety. Check out the latest e-book from Pharmaceutical Online.
More Content CollectionsSUPPLIER NEWS
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Upperton Granted MHRA Licence For Annex 1 Aligned Sterile Manufacturing Facility9/17/2026
Upperton, a UK-based contract development and manufacturing organisation (CDMO), today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a variation to its existing Manufacturing and Importation Authorisation for Investigational Medicinal Products (MIA(IMP)) licence, extending its scope to include the company’s new Annex 1-aligned sterile manufacturing facility at Trent Gateway, Nottingham.
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Hovione Opens New Facility At New Jersey Campus, Doubling U.S. Spray Drying Capacity9/16/2026
Hovione, a globally-integrated pharmaceutical Contract Development and Manufacturing Organization (CDMO), has opened 89 Twin Rivers, a new 31,000-square-foot facility at its East Windsor, N.J. campus that doubles the company's U.S. spray drying capacity and further reinforces Hovione´s global leadership in this technology platform.
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Samsung Biologics Signs USD 262 Million Manufacturing Agreement With European Pharmaceutical Company9/15/2026
Samsung Biologics’ new $262 million manufacturing agreement, extending through 2033, underscores strong long-term demand and business momentum as the company rapidly expands its global capacity, capabilities, and portfolio to support continued growth.
