FEATURE ARTICLES
Constructing greenfield fill finish sites is always a complex task, but throw in there the added challenge of delivering the site expediently, and the task becomes increasingly complicated.
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
- February 2026 — CDMO Opportunities And Threats Report
- FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
- Clearing The Fog On New First Air Visualization Expectations
- FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
- From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna
PHARMA ONLINE WHITE PAPERS
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The Future Of Cleaning Validation
Explore evolving cleaning validation strategies in life sciences, from regulatory foundations to digital innovations, and discover how agile, risk-based approaches can enhance compliance and efficiency.
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Why Biopharma Breakthroughs Aren't Moving The Market10/20/2025
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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Accelerated API Manufacturing: Combining All Process Development Stages3/17/2026
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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White Paper: Characterization Of Spray Dried Biologics5/7/2025
Discover how spray drying can transform the formulation of complex biologics by improving stability, delivery, and functionality, with insights into the critical techniques and strategies needed for successful development.
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The Benefits Of Incorporating Lean Methodologies Into Project Management8/20/2024
Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.
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Continuous Flow — An Emerging Alternative3/17/2026
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.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 04.04.26 -- Quality Assurance Product Showcase
- 04.03.26 -- 4 Facility Considerations For API Manufacturing
- 04.02.26 -- Automation That Delivers: From Liquid Handling To Cell Lines
- 04.02.26 -- Generative AI Can Write The Code, But Who Builds In The Quality?
- 04.02.26 -- STREAM Edition: Reducing Costs And Maintaining Quality
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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Symbiosis Expands Commercial Capabilities With Addition Of New Stability Chamber4/1/2026
Symbiosis Pharmaceutical Services (Symbiosis), a Contract Development and Manufacturing Organisation (CDMO) specialising in the sterile GMP manufacturer of injectable drug products, has expanded its Quality Control (QC) laboratory with the installation of a new 30°C stability chamber.
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Eli Lilly's Foundayo™ Approved By FDA, Introducing A New Era Of Needle-Free GLP-1 Therapy4/1/2026
Foundayo, Lilly's second FDA-approved obesity medicine, will be available via LillyDirect® with free home delivery, starting at $25 per month with commercial coverage and $149 for self-pay
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ROIS CDMO Closes On The Acquisition Of US Injectable Manufacturing Facility4/1/2026
ROIS, the CDMO arm of ROVI and a leader in injectable manufacturing, today announces closing the acquisition of a state-of-the-art injectable drug product manufacturing and packaging site in Phoenix, Arizona (USA) from Bristol Myers Squibb.
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IMA Acquires Isolator Equipment Provider Prosys Sampling Systems Limited4/1/2026
The IMA Group strengthens its presence in aseptic and containment isolator technology. IMA has recently signed with ProSys Sampling Systems Limited an agreement that provides for the purchase of a majority of the company’s shares. Established in 1997, ProSys is a leading provider of Isolator and Sampling equipment to the global bio-pharmaceutical market.
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Samsung Biologics Completes Acquisition Of GSK's Manufacturing Facility In Rockville, Maryland3/31/2026
Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), today announced the completion of its acquisition of a manufacturing facility in Rockville, Maryland from GSK, establishing the company's first manufacturing presence in the United States.