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-1600719545 lab]( "Why Biopharma Breakthroughs Aren't Moving The Market")
Why Biopharma Breakthroughs Aren't Moving The MarketBiopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC1/21/2026
Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.
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Safely Scaling High Potency API Manufacturing4/13/2026
Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.
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Food Safety Digital Maturity In The Supply Chain3/17/2026
Look at how connected data and automated processes strengthen safety, improve traceability, and streamline compliance across the supply chain—offering a clear roadmap for progression.
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An Integrated Analytical Approach To Lipase Risk Management In Biologics Development9/8/2026
Conventional HCP testing cannot confirm whether residual lipases remain enzymatically active. Here, the authors examine why functional activity data are essential for managing polysorbate-related stability risk in biologics development.
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Advancing Multiomics Through Intelligent Automation10/27/2025
Modern automation tackles hidden pipetting errors and boosts reproducibility. Discover how your lab can scale confidently, reduce rework, and accelerate multiomic workflows with built-in traceability.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Multi-Technique, Vendor Neutral Analytical Data Handling For Chemists
- Use Cation Exchange Chromatography For High Yields In Vaccine Production
- Detect Low-Abundance GLP-1 Impurities With Greater Sensitivity
- Sample Quality Control In The Whole-Genome Sequencing Workflow
- Select The Best Analyte: A Guide To Effective Mycoplasma Testing
NEWSLETTER ARCHIVE
- 09.16.26 -- Fewer Setbacks, Faster INDs Through Smarter Chemistry Development
- 09.15.26 -- Consequences Of Environmental Residues In Cleanrooms
- 09.15.26 -- AI Governance Is Just Like Driving A Race Car
- 09.15.26 -- Your Collaborator: mAb Productivity And Robustness
- 09.12.26 -- Pharmaceutical Online Newsletter - Best Of August
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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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.
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Jubilant HollisterStier Announces First FDA Commercial Product Approval For Sterile Fill-Finish Line 39/10/2026
Jubilant HollisterStier (JHS) is pleased to announce the FDA regulatory approval of the first commercial sterile injectable product manufactured on its Line 3 isolator fill-finish line, marking a major milestone for the company’s expanded manufacturing operations at its Spokane facility.
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Lonza Further Strengthens US Manufacturing Presence With Addition Of A Commercial Spray-Drying Facility In Bend, Oregon9/10/2026
Lonza, the world’s leading contract development and manufacturing organization (CDMO), announced today plans to further strengthen its significant US presence by constructing a large-scale commercial spray-drying facility in Bend, Oregon. The investment will establish Lonza as the leading CDMO provider of commercial-scale spray-drying PSD-4 capacity in the US.
