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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![Audit and inspection-iStock-1205235181]( "FM Approval Standard 4882")
FM Approval Standard 4882A fire in a pharmaceutical cleanroom can be contained, but for sterile manufacturers, smoke can turn a localized event into a far wider decontamination, requalification, and production-recovery challenge.
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Optimizing mAb Production: Upstream Process Intensification Strategies9/1/2026
See how integrated upstream and downstream intensification strategies can increase monoclonal antibody yield, streamline workflows, improve facility utilization, and reduce manufacturing costs.
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Digital Maturity In Life Sciences Quality And Manufacturing6/17/2025
Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.
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Transformative Innovation: Advancing Drug Development Using In Silico Modeling3/4/2026
Explore how predictive modeling and in silico strategies can turn complex data into actionable insights that accelerate drug development and reduce risk across the development lifecycle.
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GLP-1 Peptides Around The World8/12/2026
Explore how evolving regulations, supply constraints, and reimbursement models shape GLP-1 drug development across the U.S., Europe, and Asia.
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Patented Process For Intermediates Useful For Deucravacitinib3/13/2026
Discover how this patented synthetic approach to Deucravacitinib intermediates can improve yield, simplify purification, and support scalable, regulatory-aligned manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
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.
