FEATURE ARTICLES
A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced.
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- 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- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance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
PHARMA ONLINE WHITE PAPERS
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![GettyImages-958727106-chain-links-glowing-yellow]( "Quality: The Link Between Platform, Processes, And Patients")
Quality: The Link Between Platform, Processes, And PatientsQuality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.
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Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends3/12/2025
Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.
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Accelerated API Manufacturing: Combining All Process Development Stages3/17/2026
During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.
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Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody Derivatives11/3/2025
Due to the complexity of bispecifics, Fc-fusion proteins, and Fab fragments, their manufacturing poses added purification challenges and requires a robust toolkit of purification techniques.
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What Pharmacies Often Miss In USP <800> Compliance5/27/2026
Master USP <800> compliance by transitioning from standalone equipment to an integrated system design. Review key protocols for a multi-layered strategy to mitigate cumulative drug risks.
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Redefining OSD Development Through Foresight And Innovation2/12/2026
From early formulation challenges to scale-up and commercial readiness, proactive planning and integrated capabilities help teams anticipate risks, accelerate decision-making, and maintain momentum across development.
PHARMA ONLINE APP NOTES & CASE STUDIES
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.
