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 State Of Digital Maturity In Pharma And Medtech Manufacturing
Explore results from a study aiming to understand why numerous companies continue to rely on manual, paper-based systems, and gain insight into how your competitors are gaining a competitive advantage.
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The Evolution Of Antibody-Drug Manufacturing6/3/2024
Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
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The Impact Of Annex 1 (2022) On Sterility Assurance4/24/2025
Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
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Accelerating Antibody-Drug Conjugate (ADC) Development10/29/2025
Explore how automated immunoassays help overcome ADC bioanalysis challenges, reducing hands-on time, improving throughput, and enabling multi-analyte workflows for more efficient assessments.
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Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy2/6/2026
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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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.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 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
- 03.30.26 -- Rethink Your Equipment Strategy Before Your Next Capital Decision
- 03.26.26 -- STREAM Edition: Understanding Barrier Systems
- 03.25.26 -- A simple, helpful look at PUPSIT implementation.
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.