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-153664932-scientist-pipette-gloves-assay]( "Advancing Multiomics Through Intelligent Automation")
Advancing Multiomics Through Intelligent AutomationModern 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.
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Accelerating An Innovative High Potency Oncology Therapy To Market5/13/2026
Learn how disciplined containment, proactive risk management, and collaboration accelerate complex oncology programs under tight timelines while protecting quality, safety, and global launch readiness.
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Optimizing DPI Production: Filling Technologies For Precision And Performance4/16/2025
Developing effective dry powder inhalers requires expertise across multiple disciplines, from particle engineering and device technology to manufacturing science and regulatory knowledge.
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FDA's Regenerative Medicine Advanced Therapy (RMAT) Program12/10/2025
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.
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Continuous Flow — An Emerging Alternative3/17/2026
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
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Isolate Bright GFP-Expressing HEK293 Cells For Cell Line Development Workflow11/7/2025
Explore a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 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
- 09.09.26 -- Mastering Nanoparticle Engineering And Oral Solid Dose Formulation
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.
