FEATURE ARTICLES
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
- 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
- Top 7 AI Lessons Learned
- An AI Use Case in Pharma Process Optimization
- Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
PHARMA ONLINE WHITE PAPERS
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![GettyImages-2176475661 tabet press, pharma manufacturing]( "Quality By Design In The Pharmaceutical Industry")
Quality By Design In The Pharmaceutical IndustryReal-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
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Membrane Filter Pore Size Impact On Colony Size, Microbial Recovery1/31/2024
Explore results from a study evaluating the effects of different pore sizes on colony size and microbial recovery using membrane filters.
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Advancing QC Efficiency With SEC-MALS System And Empower Software7/31/2025
Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.
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Best Practices In Commissioning And Qualification7/5/2024
An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
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Navigating The FDA's Drug Supply Chain Security Act3/14/2025
Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.
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How Automation Is Driving Carbon Reduction10/21/2025
Manufacturers can cut emissions and boost efficiency by modernizing energy and utility systems. Explore how smart automation and analytics offer fast ROI and long-term sustainability.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 01.22.26 -- Multiparticulates, Minitabs, And Microencapsulation For Improved Patient Adherence
- 01.22.26 -- Top 7 AI Lessons Learned
- 01.22.26 -- STREAM Edition: The Module Type Package Wants All Your Equipment To Start Talking
- 01.20.26 -- A 2025 Pharma Look Back And Look Forward: Editor Style
- 01.20.26 -- Microbial Monitoring That Supports Annex 1 Compliance
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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Genentech To Double Its Investment At North Carolina Drug Manufacturing Facility1/22/2026
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced an expansion of its initial investment in a new Holly Springs, North Carolina manufacturing facility. The increased investment will more than double the total commitment for the company’s first-ever East Coast manufacturing facility to approximately $2 billion.
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CDMO Alcami Expands RTP Footprint With New Durham Facility And Major Lab Expansion1/20/2026
Alcami Corporation, a leading U.S.-based contract development and manufacturing organization (CDMO), has acquired a 37,000-square-foot facility at 4620 Creekstone Drive in Durham, North Carolina. This $6.7 million investment strengthens Alcami's presence in the Research Triangle region and supports the company's continued expansion of advanced laboratory services.
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Wilmington PharmaTech Appoints Seasoned Commercial Leader To Drive Growth1/16/2026
Wilmington PharmaTech (“WPT”), a U.S.-based specialty contract research, development and manufacturing organization (CRDMO) focused on complex custom small molecule API, today announced that it has appointed Mike Shearer to the role of Chief Commercial Officer, where he will play a pivotal role in driving growth, strengthening client partnerships, and furthering the organization’s position as a trusted partner for API development and manufacturing. Shearer will report to Hui-Yin “Harry” Li, Ph.D., WPT’s Founder and CEO.
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Coating Place Secures Growth Capital Investment By 1315 Capital1/16/2026
Coating Place, a leading U.S.-based contract development and manufacturing organization (CDMO), has secured a strategic, growth investment from 1315 Capital, a Philadelphia-based healthcare-focused private equity firm.
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INTERPHEX Opens Registration For 2026 With Expanded Show Floor, Education And Debut Of New Contract & Outsourcing Hub1/14/2026
INTERPHEX, the premier pharmaceutical and biotechnology event returns to NYC, taking place April 21 – 23 at the Javits Center. Representing the full scope of the pharmaceutical value chain, INTERPHEX continues to be the event to discover breakthrough solutions that enhance manufacturing, development, regulatory compliance and supply chain efficiency to support the evolving industry.
