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-1767170794-GLP-1-peptide-chain]( "GLP-1 Peptides Around The World")
GLP-1 Peptides Around The WorldExplore how evolving regulations, supply constraints, and reimbursement models shape GLP-1 drug development across the U.S., Europe, and Asia.
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The AI-Ready Factory: How IT/OT Integration Transforms Manufacturing Data7/21/2026
Pharmaceutical manufacturers need more than raw production data to scale AI. Learn how contextualized, governed IT/OT integration can turn disconnected shop-floor signals into real-time decisions.
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Where Speed Meets Complexity In Bioprocess Development6/18/2026
Bioprocessing faces mounting pressure to compress timelines, especially for mAbs, while complex modalities like bispecifics and gene therapies introduce technical challenges. Process intensification, scale-up translation, and comparability risks remain critical hurdles.
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Get More From Less: AMP Chemistry Outperforms Hybrid Capture6/9/2026
Sequencing performance can drop quickly with low-quality, low-input FFPE DNA. Gain insight into how one approach helps labs minimize repeats and maintain more consistent results.
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Improving API Solubility3/3/2025
Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.
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Extraction And Chemical Characterization Pitfalls In Complex Medical Devices8/20/2026
Standard extraction protocols routinely fail tissue-derived products, hydrogels, absorbables, and silicone implants. Learn the material-specific study design strategies that prevent regulatory rejection and repeat work.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Measuring ADC Positional Isomers Using Nonreduced CE-SDS And HIC
- A Paperless Lab Simplifies, Accelerates Full Sample Lifecycle Data Management
- Digital Transformation Optimizes Production, Quality, And Compliance
- Enable Low Volume Delivery Of Proteins In Aqueous Solutions
- IVT mRNA Encapsulation Efficiency Assessment
NEWSLETTER ARCHIVE
- 09.17.26 -- How Leading Teams Reduce Risk And Improve Readiness
- 09.17.26 -- Controls For Retrieval-Augmented Generation In GxP
- 09.17.26 -- Quantifying And Characterizing Impurities
- 09.16.26 -- Fewer Setbacks, Faster INDs Through Smarter Chemistry Development
- 09.15.26 -- Consequences Of Environmental Residues In Cleanrooms
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.
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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.
