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-2213666852-fluid-handling-laboratory-syringe-gloves]( "Determining The True Cost Of Single-Use Fluid Management")
Determining The True Cost Of Single-Use Fluid ManagementLooking beyond unit price reveals how reliability, leak prevention, and shelf life affect bioprocessing costs. Make purchasing decisions that support resilient and predictable operations.
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Why Get Cleaning Validation Support From The Cleaner Supplier?6/22/2026
Standardize compliant cleaning by integrating risk-based validation, effective residue detection, and science-based limits to reduce cross-contamination and protect product quality.
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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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Advancing Multiomics Through Intelligent Automation10/27/2025
Modern 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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Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility6/4/2025
Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines1/9/2026
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
PHARMA ONLINE APP NOTES & CASE STUDIES
- NGS Analysis Of Hereditary Cancer Predispositions
- Environmental Monitoring In Advanced Therapeutic Medicinal Products Facilities
- Collagen Based Products For Regenerative Medicine
- Accelerating Method Development And Manufacturing Of GLP-1 Analogs
- Understanding Technology Transfer In Pharmaceutical Contract Manufacturing
NEWSLETTER ARCHIVE
- 09.10.26 -- Paper To Digital Transition And Paper Fallback
- 09.09.26 -- Mastering Nanoparticle Engineering And Oral Solid Dose Formulation
- 09.09.26 -- Detect GLP-1 Impurities Faster With Advanced LC-MS Workflows
- 09.08.26 -- Accelerating Sterile Drug Product Development
- 09.08.26 -- Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
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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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.
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Cambrex High Point Completes FDA, PMDA And TGA PreApproval Inspections, Advancing Commercial Manufacturing Capabilities8/25/2026
Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced the successful completion of three Pre-Approval Inspections (PAIs) at its High Point, North Carolina facility by the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA). The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia, establishing the facility as the newest commercial manufacturing site within the Cambrex global network.
