FEATURE ARTICLES
Regulatory changes, space/footprint constraints and expanding automation garnered more votes than the other challenges. Let’s explore these challenges, and see how the industry is tackling them as we move into 2026.
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- December 2025 — CDMO Opportunities And Threats Report
- 5 FDA Approval Categories In 2025
- A 2025 Pharma Look Back and Look Forward: Editor Style
- 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
- A Deeper Look At Pharma's Structural Supply Chain Vulnerability
PHARMA ONLINE WHITE PAPERS
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What Pharma And Biopharma Should Know About Container Closure Integrity
Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical manufacturing.
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Exploring The Potential Of Agentic AI8/12/2025
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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Selecting The Best Deterministic Method For Your CCIT Project3/31/2025
Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.
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Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs8/27/2024
Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.
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Leveraging Digitalization To Resolve CGT Manufacturing Challenges2/12/2025
Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.
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Sustainable Solutions For Medical Devices1/6/2025
Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 02.07.26 -- Oral Solid Dose Manufacturing Product Showcase
- 02.06.26 -- Biological Indicator Testing – Meeting Regulatory Demands With Confidence
- 02.05.26 -- STREAM Edition: Contamination Control Strategies For Drug Manufacturers
- 02.03.26 -- Novo's Path To The First GLP-1 Weight Loss Pill
- 02.03.26 -- Composable MES For Pharma
INDUSTRY NEWS
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Høeg In, Pazdur Out At The FDA
What 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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9 Drugs Granted Fast Track By FDA's Voucher Program
With 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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Leaders In The Excipient Market: Region And Type
Though 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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Pfizer Strengthens Obesity Foothold With Metsera Acquisition
After 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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FDA Cracks Down On GLP-1 Imports
GLP-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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Is A Cybersecurity Boom On The Horizon? KPMG Survey Shows Surge In Cybersecurity Investment As AI Threats Redefine Risk2/5/2026
A cybersecurity boom appears imminent as businesses invest to defend against a new generation of sophisticated, AI-driven threats. According to the 2025 KPMG Cybersecurity Survey, a staggering 99% of security leaders plan to increase their cybersecurity budgets over the next two to three years, signaling that cybersecurity is no longer just a priority but a critical business imperative.
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Eli Lilly To Build New $3.5B Injectable Drug Manufacturing Site Supporting GLP-1 Therapies In Pennsylvania2/2/2026
Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $3.5 billion in a new manufacturing facility in the Lehigh Valley, Pennsylvania.
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Halo Pharma To Become A Stand-Alone Drug Product Contract Development And Manufacturing Organization (CDMO)1/27/2026
Halo Pharma, a leading CDMO specializing in drug product pharmaceutical development and manufacturing services, will become a stand-alone business as a result of the sale of the Noramco API and associated businesses to Siegfried.
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Eurofins CDMO Alphora Announces Development & Implementation Of AI-Powered Salt And Co-Crystal Screening Software1/26/2026
Developed by Eurofins CDMO Alphora, in collaboration with a local university, this cutting-edge machine learning platform provides highly accurate predictions of salt and co-crystal formation for APIs and intermediates.