FEATURE ARTICLES
Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.
- Unpacking The EU's Mutual Recognition Agreements For Pharma
- It's Copy/Paste In Fleet Management Manufacturing
- The Module Type Package Wants All Your Equipment To Start Talking
- FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
- Leveraging Historical Data to Accelerate Process Understanding
- Fostering A Quality Software Culture
- Lessons In Quality From Sanofi's Plai.qa
PHARMA ONLINE WHITE PAPERS
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Enabling The Future Of Intensified Biomanufacturing
Process intensification demands smarter orchestration, real-time analytics, and scalable automation. Discover how digital infrastructure enables synchronized, compliant, and predictive biomanufacturing.
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The Problem With Construction Quality10/21/2024
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.
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Reducing ADC Timelines With Integrated Development And Manufacturing4/8/2024
ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing6/13/2025
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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Driving Digital Excellence In Life Sciences7/1/2025
The life sciences industry is rapidly evolving through digital transformation and agility. Discover why embracing modern technologies is essential to thrive in today’s competitive landscape.
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Advancing Multiomics Through Intelligent Automation10/27/2025
Modern automation tackles hidden pipetting errors and boosts reproducibility. Discover how your lab can scale confidently, reduce rework, and accelerate multiomic workflows with built-in traceability.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission
- A Temperature-Stable Replacement For Animal Trypsin In Cell Dissociation Applications
- How To Successfully Isolate Your T Cells
- Method Migration Of A Normal Phase HPLC Method For Tocopherols
- Streamlining Compliance With Pre-Clinical Safety Tests
NEWSLETTER ARCHIVE
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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Groninger Apprentices Mark Career Milestones12/17/2025
groninger USA proudly announces the graduation of apprentices Connor Benito and Logan Busteed, who today receive their Associate Degrees in Mechatronics Engineering Technology from Central Piedmont Community College. Both young professionals joined groninger’s highly regarded apprenticeship path and now mark a milestone in their technical careers.
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CDMO Incog Biopharma Announces $200 Million Manufacturing Expansion In Indiana12/17/2025
INCOG BioPharma Services, a leading contract development and manufacturing organization (CDMO), today announced another major expansion with an investment of approximately $200 million in its manufacturing facility in Fishers, Indiana. This investment will significantly increase the company’s injectable drug product manufacturing capacity.
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$6B Commitment: Eli Lilly Expands U.S. Manufacturing With New Huntsville Facility12/10/2025
Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $6 billion in a new manufacturing facility in Huntsville, Alabama. This next-generation synthetic medicine active pharmaceutical ingredient (API) facility, the third of four new U.S. sites Lilly plans to announce, will produce small molecule synthetic and peptide medicines.
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Bora Pharmaceuticals And Corealis Pharma Forge Strategic Alliance To Deliver Seamless, End-To-End Oral Solid Dose Development12/9/2025
Bora Pharmaceuticals Co., Ltd. (“Bora”, TWSE: 6472), a global leader in pharmaceutical manufacturing, and Corealis Pharma Inc., a leading early-phase Contract Development Manufacturing Organization (CDMO), have entered into a strategic alliance to provide end-to-end services for oral solid dose (OSD) development and manufacturing. The collaboration will simplify the drug development process and provide a more scalable pathway to commercialization via a single continuum.
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Marchesini Group And AST Unite To Expand Global Sterile Fill-Finish Capabilities12/9/2025
Marchesini Group, a leader in pharmaceutical packaging machinery, and AST, a U.S leader in the drug product manufacturing industry, have entered a strategic partnership that combines the expertise, technologies, and global reach of two highly respected industry leaders.