FEATURE ARTICLES
Success depends not only on equipment and infrastructure, but also on specialized workforce training, rigorous quality control, robust data management, and increasingly sophisticated supply chain and manufacturing technologies.
- February 2026 — CDMO Opportunities And Threats Report
- FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
- Clearing The Fog On New First Air Visualization Expectations
- FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
- From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Where Contamination Control Really Breaks Down In Practice
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1288978528 Scientist Using Microscope In Lab]( "A New Framework For Identifying Nitrosamine Risks And Derisking Products")
A New Framework For Identifying Nitrosamine Risks And Derisking ProductsExamine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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Improving Gene Therapy Development With Organ-On-A-Chip Technology8/7/2024
Explore the current challenges of developing gene therapies, the potential of Organ-on-a-Chip technology, the future of gene therapy, and more.
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Oligonucleotide Synthesis: Scale-Up Made Simple10/16/2024
Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.
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Mitigating Early Development Risks9/11/2024
Discover how the efficient screening of biologic candidates accelerates the discovery process, reduces costs, and improves the likelihood of commercializing safe and effective drugs.
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Building Digital Capabilities For An Intelligent Tomorrow7/29/2025
Explore how modern manufacturing software is transforming operations with AI-driven insights to empower CDMOs and CMOs to boost efficiency, agility, and client satisfaction in a competitive landscape.
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The GxP Digital Maturity Model8/8/2025
Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test
- Can Your Biopharma Team Keep Unplanned Downtime At Bay?
- Product Recovery Study For Fill Finish Applications
- Engineering The Future Of Lipsomal Drug Delivery
- Ringing The Alarm: Unified Data For GMP Annex 1 Compliance
NEWSLETTER ARCHIVE
- 03.26.26 -- STREAM Edition: Understanding Barrier Systems
- 03.25.26 -- A simple, helpful look at PUPSIT implementation.
- 03.24.26 -- Raising The Bar In Radiopharmaceutical Manufacturing
- 03.23.26 -- Ensuring Product Safety And Compliance With Advanced Inspection Technologies
- 03.21.26 -- Software Product Showcase
INDUSTRY NEWS
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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.
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![weight loss, diabetes, insulin pen-GettyImages-2196049931]( "FDA Cracks Down On GLP-1 Imports")
FDA Cracks Down On GLP-1 ImportsGLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.
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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TerraPower Isotopes Announces Plans To Build New cGMP Drug Manufacturing Facility In Philadelphia3/23/2026
TerraPower Isotopes® (TPI®) announced today that the company is building its flagship current Good Manufacturing Practices (cGMP) actinium-225 (ac-225) manufacturing facility in the Bellwether District of Philadelphia, Pennsylvania.
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Axplora Announces $60 Million High Potency API Manufacturing Facility Expansion In Italy3/17/2026
Axplora, a global leader in complex active pharmaceutical ingredient (API) manufacturing, today announced a major milestone in its $60 million investment programme in highly potent API (HPAPI) manufacturing at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-storey R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale.
