FEATURE ARTICLES
Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.
- 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- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance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
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
PHARMA ONLINE WHITE PAPERS
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![Scientists In Lab Working Together On Digital Tablet GettyImages-893884830]( "The Complete Guide To Immunohistochemistry")
The Complete Guide To ImmunohistochemistryImmunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
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Optimal Microbial Sampling Criteria6/24/2025
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
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Calculating The ROI Of EAM/CMMS For Pharma Manufacturers And CDMOs10/6/2025
Learn how modern EAM and CMMS systems help pharma manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.
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Accelerating Biologics With Seamless Technology Transfer6/17/2026
Discover how effective technology transfer strategies can streamline scale-up, maintain product quality, and enable successful clinical and commercial manufacturing.
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Three Steps To Digital Transformation In Life Sciences Manufacturing1/30/2025
Explore trends that are transforming the industry, some common speedbumps on the road to innovation, and how a new platform offers unprecedented process transparency and continuous improvement.
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Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future9/16/2025
See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Powder Rheology: Gateway For Tablet Sticking Insights
- Boosting Cell Culture Yields With Intensified Fed Batch Processing
- High Precision Mass Inspection With Accuracy Of ±0.5 mg Achieved
- Measuring AAV Vector Genome Titer Using Droplet Digital PCR Protocol
- Developing A Quantitative Surrogate Peptide Assay
NEWSLETTER ARCHIVE
- 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
- 07.09.26 -- Manufacturing Insights for Large Molecule Development
- 07.09.26 -- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
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.
