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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Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins
Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.
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Improving AAV Manufacturing: Advancements In Full Capsid Enrichment8/19/2026
As AAV manufacturing matures, integrated optimization of capture, buffer chemistry, load conditioning, and AEX polishing enables scalable full capsid enrichment, improving product quality and manufacturability.
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Isolator Integration In Cell And Gene Therapy Manufacturing5/27/2026
Safeguard living medicines with a tailored facility design strategy. Evaluate workflows with this six-dimensional model against your CCS for a holistic look to inform your decisions.
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SEDDS: Improving Oral Bioavailability Of Poorly Soluble Compounds8/20/2026
Nearly 90% of marketed drugs have poor water solubility. Learn how self-emulsifying drug delivery systems (SEDDS) resolve oral bioavailability failures across BCS Class II and IV compounds.
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Why Pharmaceutical Scientists Trust The Discovery Core Rheometer5/1/2026
Drug formulations demand more than single‑point viscosity data. Explore how rheology reveals stability, flow, and structural behavior across suspensions, topicals, and injectables.
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Optimize Time, Space and Cost With Inline Buffer Formulation And System4/7/2026
Discover how integrating inline buffer formulation with chromatography reduces buffer waste by 50% and delivers a 710% ROI, transforming downstream efficiency and sustainability.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Solutions For CQA Analysis Of IVT mRNA-Based Biotherapeutics
- Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination
- Formulation & Delivery Of Spray Dried Biologics For Nasal Dosage Forms
- Denaturing SEC-MS Analysis Of High Molecular Weight Impurities
- Analyzing Poly(A) Tails Of In Vitro Transcribed RNA
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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Let Your Voice Help Shape Pharma Manufacturing
Pharmaceutical 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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ISPE Announces 2026 FOYA Winners
These 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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Høeg In, Pazdur Out At The FDA
What 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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9 Drugs Granted Fast Track By FDA's Voucher Program
With 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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Leaders In The Excipient Market: Region And Type
Though 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.