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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![Copyright-GettyImages-451356291]( "IP Considerations In Drug Development For Biotech Companies")
IP Considerations In Drug Development For Biotech CompaniesIntegrate a strategic intellectual property approach early in drug development to streamline research, uncover opportunities, and maximize the return on your investment.
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5 Steps To Design A Microbiological Performance Qualification For Facilities4/21/2025
Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
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Drug Substance For Early Clinical Phase Initiation5/6/2026
Explore how proactive nitrosamine impurity risk assessment protects early clinical drug supply, minimizes development delays, and enables confident progression to first‑in‑human studies.
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing6/13/2025
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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For Greater Transparency And Efficiency7/21/2026
Paper-heavy production can slow decisions and limit flexibility. See how IT/OT integration connects shop-floor and enterprise data to support real-time visibility and more resilient operations.
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Digital CMC Maturity: Rethinking QTTP And Control Strategy9/2/2026
Digital CMC maturity depends on structured, science- and risk-based knowledge. Learn how connecting development, validation, regulatory, and lifecycle information can accelerate timelines.
PHARMA ONLINE APP NOTES & CASE STUDIES
- CQA Assessment Of LNP-Encapsulated IVT mRNA
- A Universal Workflow Approach For Single Cell Mass Spectrometry Based Proteomics
- Cryogenic Storage Of IV Bags For Cell And Gene Therapies
- Can Your Biopharma Team Keep Unplanned Downtime At Bay?
- Biotech Firm Streamlines Maintenance, Calibration & Validation With RAM
NEWSLETTER ARCHIVE
- 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
- 09.09.26 -- Detect GLP-1 Impurities Faster With Advanced LC-MS Workflows
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.
