FEATURE ARTICLES
A technology transfer can falter long before a process reaches the plant. Gaps in process knowledge, mismatched equipment, and insufficient scale-up data can all undermine reproducibility, timelines, and cost.
- AI Fills The Decision-Making Gaps In Process Analytical Technology
- You Can't CAPA What You Can't Classify
- 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
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1316775813 fill finish pharmaceutical bottles]( "Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future")
Fill-Finish Contract Manufacturing: Trends, Challenges, And The FutureSee why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.
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A Guide To Process Transparency In Custom Lab Automation Development3/16/2026
Discover a practical guide to building custom automation systems with clarity and confidence, as well as how transparent processes reduce risk, prevent misalignment, and support reliable testing.
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The Impact Of Artificial Intelligence On CQV7/23/2025
AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.
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The Strategic Value Of In-House Delumping For Homogeneous API Production9/9/2026
API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.
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Leveraging Digitalization To Resolve CGT Manufacturing Challenges2/12/2025
Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.
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The Complete Flow Cytometry Guide9/24/2024
This guide covers the fundamentals of flow cytometry, aiming to help you better understand how it works, when it is most valuable, and how to conduct an experiment.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 09.22.26 -- From Bench To Batch: Modernizing CMC For Faster Decisions
- 09.22.26 -- AI Fills The Decision-Making Gaps In Process Analytical Technology
- 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
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.
