FEATURE ARTICLES
A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
- How To Avoid The Biggest USP <665> Compliance Trap
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- Inside Chugai's Digital Infrastructure Strategy
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- What Biopharma Often Overlooks In A Scheduled Shutdown
- [VIDEO] GLP-1 Manufacturing's New Bottlenecks At Multi-Ton Scale
PHARMA ONLINE WHITE PAPERS
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![quality control business goal-GettyImages-1613839148]( "Developing Effective Procedures")
Developing Effective ProceduresEffective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
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Deciphering The Complex Characteristics Of Nanomedicine5/6/2026
Gain deeper insight into nanomedicine characterization, showing how critical quality attributes, advanced analytics, and phase‑appropriate strategies drive safety, efficacy, and regulatory readiness.
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Advancing Drug Development With Optimized LC-MS/MS Bioanalysis5/7/2025
Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.
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Exploring Agentic AI In GMP Operations8/12/2025
Discover how agentic AI is poised to transform Enterprise Asset Management in regulated industries to enhance compliance, reduce downtime, and bridge fragmented systems for resilient operations.
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Accelerated Development Of Solid Oral Dosage Formulation For IND Submission12/11/2024
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
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Accelerate Lead Times Through Seamless External Collaboration In Quality5/21/2026
As CDMO networks expand, disconnected quality processes create delays and risk. Learn how seamless external collaboration improves visibility, accelerates approvals, and strengthens sponsor–partner relationships—helping teams move faster without compromising compliance.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Fast And Efficient Processing Of ELISA Assays
- Adapt Or Fail: The Urgency Of Pandemic Preparedness For Sterile Injectable Manufacturing
- Quantification Of Semaglutide With A Reliable Analytical Method
- Phototrophic Cultivation Of Chlorella vulgaris In Microbioreactors
- Forge Boosts Efficiency And Compliance During External Collaboration
NEWSLETTER ARCHIVE
- 07.14.26 -- Practical Strategies for Contamination Control and EM Compliance
- 07.14.26 -- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- 07.11.26 -- Pharmaceutical Online Newsletter - Best Of June
- 07.11.26 -- Facilities And Cleanrooms Product Showcase
- 07.10.26 -- [VIDEO] GLP-1 Manufacturing's New Bottlenecks At Multi-Ton Scale
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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Amneal's Planned Sterile Facility Creates Opportunity For Aseptic Filling, Isolator, And Automation Suppliers7/8/2026
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced it has been selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA PreCheck Pilot Program for the company's planned sterile manufacturing facility in Brookhaven, New York.
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AustinPx Expands KinetiSol™ Technology Commercial Access Through Thermo Fisher Scientific Collaboration6/30/2026
AustinPx, a contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement for orally delivered small molecule drugs, today announced its agreement with Thermo Fisher Scientific’s Patheon pharma services for the installation of AustinPx’s KinetiSol™ Technology equipment.
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Recipharm Invests In U.S. Fill-Finish Infrastructure To Accelerate Biologics Development6/17/2026
Recipharm, a leading global contract development and manufacturing organisation (CDMO), today announced a multi-million-dollar investment in its US operations, strengthening its ability to support pharmaceutical and biotechnology companies with advanced sterile fill and finish services for biologics and advanced therapies.
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Four Myths About Embedded CMOs, Busted6/17/2026
If you’re looking for a contract manufacturer to bring your therapy to market, you’re far from alone. Demand for manufacturing services is shaping the pharma Contract Manufacturing Industry, with analysts predicting a growth rate of nearly 7% per year until 2028.
