FEATURE ARTICLES
EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.
- Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit
- Rethinking CQV In A Digital, Agile Manufacturing Landscape
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
- Why Contamination Control By Design Should Matter To Your CDMO
- Closing The MES Value Gap: Why Technology Isn't The Problem
- Makary's Exit Raises New Questions About FDA Stability And Direction
PHARMA ONLINE WHITE PAPERS
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![getty-1311598658-data-analytics]( "Enabling Quality By Design")
Enabling Quality By DesignOutdated quality systems delay product release. Discover how manufacturers can harness real-time data, operationalize QbD, and enhance compliance, efficiency, and supply chain continuity.
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Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities6/12/2025
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
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The Evolution Of EAM/CMMS In Pharma Manufacturing8/8/2025
Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.
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The TIDES Manufacturing Mandate: Why Incrementalism Fails And Integration Prevail5/7/2026
Manufacturing strategies for peptides and oligonucleotides are being reshaped by scale, complexity, and chronic use. An integrated, end‑to‑end approach shows how early design decisions can prevent costly bottlenecks later.
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Leveraging Flow Chemistry1/22/2026
Discover how continuous processing cuts waste, improves efficiency, and supports safer, scalable reactions while helping teams meet sustainability goals and speed development.
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The Impact Of Annex 1 (2022) On Sterility Assurance4/24/2025
Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Robust, High-Throughput Automated Solution For Water Endotoxin Testing
- Maximizing Scale-Up Efficiency Of A mAb Upstream Process
- Benchmarking Filtration Performance Of TFF Cassettes
- Getting The Most Out Of Cell-Based Assays With The Optimal Read Function
- Adapt Or Fail: The Urgency Of Pandemic Preparedness For Sterile Injectable Manufacturing
NEWSLETTER ARCHIVE
- 05.29.26 -- Why Isolators Do Not Automatically Ensure Annex 1 Compliance
- 05.28.26 -- Smarter Cleanrooms Start Here: AI, BFPC & Facility Monitoring Insights
- 05.28.26 -- Makary's Exit Raises New Questions About FDA Stability And Direction
- 05.28.26 -- STREAM Edition: Get It Right With The Gemba
- 05.27.26 -- Rethinking Sterile Welding In Bioprocessing
INDUSTRY NEWS
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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.
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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
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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Inside Information: Nanoform Signs First Exclusivity Agreement For Ultra-High Concentration Subcutaneous Delivery5/12/2026
Helsinki, Finland – Nanoform Finland Plc (“Nanoform”), the medicine performance‑enhancing company, today announced that it has signed an exclusivity agreement with a U.S. biopharmaceutical company (Nasdaq listed, Mcap USD 1Bn+) for the application of Nanoform’s proprietary biologics nanoparticle technology to support the development of differentiated subcutaneous biologic medicines.
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Compact & Powerful Double Planetary Mixer For Lab And Pilot-Scaling4/30/2026
ROSS has delivered an ergonomic and powerful Double Planetary Mixer Model DPM-10 engineered for high-viscosity and specialty material processing in laboratory and pilot-scale operations.
