FEATURE ARTICLES
Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.
- Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
- November 2025 — CDMO Opportunities And Threats Report
- What 2025 FDA Warning Letters Tell Us About GMP Compliance
- 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
PHARMA ONLINE WHITE PAPERS
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Methods For Determining Equipment Capability Of Freeze-Dryers
Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
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Facilitate Handling Of Bulk Powders With Dry Granulation8/11/2025
Handling bulk powders in manufacturing presents serious challenges—from unpredictable caking to safety risks—that can disrupt workflows. Discover solutions to streamline operations and protect your team.
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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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Leak Rate Testing for Freeze Dryers: A Scientific Approach10/16/2024
Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.
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Human Skin Explant Model For The Investigation Of Topical Therapeutics8/4/2025
Learn more about an ex vivo cultured human skin explant model in which pathological tissue integrity, barrier function, and metabolic stability have been characterized over time.
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2024 Global Biopharma Sustainability Review9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
PHARMA ONLINE APP NOTES & CASE STUDIES
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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Samsung Biologics Expands U.S. Manufacturing Capabilities With Strategic Acquisition Of Human Genome Sciences From GSK12/22/2025
This strategic move secures Samsung Biologics’ first U.S.-based manufacturing site, a significant expansion of the company’s global footprint and its long-term commitment to the U.S. market.
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Techceuticals Releases 2026 Schedule For In-Person Solid Dosage Manufacturing Training12/19/2025
Techceuticals has announced its 2026 training schedule for solid dosage manufacturing, featuring a full lineup of two-day, hands-on courses covering tablet making, encapsulation, granulation, film coating, and end-to-end solid dosage processes.
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Sanofi Toronto Equipment Assets Auction Announced For January 202612/19/2025
Federal Equipment Company, a trusted global provider of surplus pharmaceutical and chemical processing equipment, announced it will conduct a two-day online auction on behalf of Sanofi featuring quality process and laboratory equipment surplus to the company’s ongoing operational needs.
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Alnylam Announces $250M Investment To Expand U.S. Manufacturing Capacity In Massachusetts For RNAi Therapeutics12/18/2025
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the planned expansion of its state-of-the-art manufacturing facility in Norton, Massachusetts. The Company is preparing to invest $250 million to advance what is poised to become the industry’s first fully dedicated, proprietary, siRNA enzymatic-ligation manufacturing facility. This investment is expected to meaningfully expand capacity, significantly reduce production costs, and position Alnylam to support future launches across its growing pipeline of potential new medicines.
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Driving Pharma 4.0: Flexible & Sustainable Facilities At PHARMAP 202612/18/2025
The shift towards Pharma 4.0 is revolutionising pharmaceutical manufacturing, introducing highly advanced, digitally interconnected and automated production plants that simplify processes and transform the industry. The future of pharmaceutical facilities is going to be the central theme of discussions at PHARMAP 2026 in Amsterdam on 20-21 April.