FEATURE ARTICLES
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
- 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
- Top 7 AI Lessons Learned
PHARMA ONLINE WHITE PAPERS
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing
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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Accelerated API Manufacturing: Combining All Process Development Stages5/16/2024
During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.
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Innovation In Filtration3/18/2025
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
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Continuous Flow — An Emerging Alternative5/16/2024
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
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A Complete Guide To Capsule Checkweighing5/2/2025
Understand why accurate capsule weighing is essential for therapeutic efficacy, safety, and adherence to pharmaceutical manufacturing standards.
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FT-IR Identifies Contaminants And Helps Avoid Hazards And Product Loss3/7/2024
Fourier Transform Infrared Spectroscopy (FT-IR) is a reliable method with multiple applications when it comes to identifying both intrinsic and extrinsic compounds in a drug product.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 02.03.26 -- Novo's Path To The First GLP-1 Weight Loss Pill
- 02.03.26 -- Composable MES For Pharma
- 01.30.26 -- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- 01.29.26 -- 5 FDA Approval Categories In 2025
- 01.29.26 -- STREAM Edition: Lessons In Scaling Regenerative Medicine Manufacturing With Organogenesis's Patrick Bilbo
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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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.
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Coating Place Announces Leadership Appointments To Support Next Phase Of Growth1/23/2026
As Coating Place celebrates its 50th anniversary, the company continues to build on its long-standing reputation as the industry leader in Wurster-based fluid bed technology for controlled release and taste masking applications.