FEATURE ARTICLES
We discuss how delivery strategy influences development decisions, learnings from advancing IHL-42X, and Latham's perspective on the future of patient-centric drug delivery.
- 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
- AI Governance Is Just Like Driving A Race Car
- Controls For Retrieval-Augmented Generation In GxP
- FDA Issues New Guidance On Therapeutic Equivalence
- July 2026 — CDMO Opportunities And Threats Report
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1938555153 tablet, lab]( "Enhancing Quality And Environmental Monitoring Efficiency Through Paperless Sampling")
Enhancing Quality And Environmental Monitoring Efficiency Through Paperless SamplingAt roughly 600,000 samples per year, manual EM documentation creates real compliance and operational risk. This whitepaper details how a fully integrated digital sampling system addresses both.
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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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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China11/11/2024
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Molecular Approaches To Streamline Cell Therapy Product Analytical Testing9/26/2025
Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.
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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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Digital Transformation And Quality By Design For Enhanced Development7/23/2025
Discover how digital transformation and Quality by Design are revolutionizing pharmaceutical development to boost efficiency, enhance compliance, and accelerate innovation across the drug lifecycle.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Simplify Process Scale-Up With An Innovative Single-Use Bioreactor
- GMP Manufacturing Cycle Time Reduction
- Sterile Filter Membrane Selection For Cell Culture Media Filtration
- Evaluating Mixing Performance Across Liquids, Solids, And Powders
- Complementary Methodologies For Analysis Of NISTmAb Impurities
NEWSLETTER ARCHIVE
- 09.12.26 -- Pharmaceutical Online Newsletter - Best Of August
- 09.11.26 -- The Complex Anatomy Of An ADC Tech Transfer
- 09.10.26 -- Smarter Ways To Reduce Risk, Downtime, And Lifecycle Surprises
- 09.10.26 -- FDA Issues New Guidance On Therapeutic Equivalence
- 09.10.26 -- Paper To Digital Transition And Paper Fallback
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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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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Ardena To Attend CPHI Worldwide Milan 2026, Launching Charity Step Challenge "From Molecules To Miles"9/9/2026
Ardena, a full-service contract development and manufacturing organization (CDMO) supporting pharmaceutical companies from molecule to market, will participate in CPHI Worldwide, taking place October 6-8, 2026, in Milan, Italy.
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JHS And Altoura Selected For BioTools Innovator VANGUARD Level Up-XR Program8/28/2026
Jubilant HollisterStier(JHS) and Altoura will be of only three company-CDMO pairs participating in the BioTools Innovator VANGUARD Level Up-XR Program.
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Syntegon Launches New Pilot Scale Tablet Coater For Small Batches8/26/2026
Syntegon, a strategic lifecycle partner to the pharmaceutical and biotech industry has expanded its Oral Solid Dosage (OSD) processing portfolio with the Sepion 75. The new pilot-scale tablet coater designed to support manufacturers and CDMOs in handling growing product diversity, smaller and more variable batch sizes, and stricter containment requirements for highly potent active ingredients. The new coater completes the established Sepion series and supports consistent scale-up, faster flexible batch processing, and containment-oriented manufacturing.
