FEATURE ARTICLES
Success depends not only on equipment and infrastructure, but also on specialized workforce training, rigorous quality control, robust data management, and increasingly sophisticated supply chain and manufacturing technologies.
- 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
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Where Contamination Control Really Breaks Down In Practice
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1401910116 green fluorescent proteins]( "Generate CHO-K1 GFP-Expressing Cells For Cell Line Development Workflow")
Generate CHO-K1 GFP-Expressing Cells For Cell Line Development WorkflowDiscover a high-efficiency workflow for generating GFP-expressing CHO-K1 clones using automated single-cell dispensing to achieve 93% isolation success and stable expression in under five weeks.
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The Importance Of Quality In Raw Material Selection1/16/2025
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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Molecular Properties Of PROTACs And The Relationship To Formulation Design3/4/2025
Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.
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Expanding Translational Research Concepts With Genedata Profiler11/26/2024
The biopharma industry leverages Genedata Profiler to integrate, curate, and analyze diverse R&D data, enabling collaborative, compliant, and AI-driven translational research to optimize drug development.
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ICH Q12 Implementation: Regulatory Intelligence And PACM Agility7/9/2024
Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.
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What Pharma And Biopharma Should Know About Container Closure Integrity8/1/2024
Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Advances In Analytical Method Selection And Technology Transfer
- Lentiviral Vector Characterization For Cell And Gene Therapy Manufacturing
- A Novel Patient-Derived Colorectal Cancer Organoid Platform
- Simplify Cell Line Development
- 3D Cell Culture Reveals Undetectable Drug Efficacy In Traditional Systems
NEWSLETTER ARCHIVE
- 03.26.26 -- STREAM Edition: Understanding Barrier Systems
- 03.25.26 -- A simple, helpful look at PUPSIT implementation.
- 03.24.26 -- Raising The Bar In Radiopharmaceutical Manufacturing
- 03.23.26 -- Ensuring Product Safety And Compliance With Advanced Inspection Technologies
- 03.21.26 -- Software Product Showcase
INDUSTRY NEWS
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![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat 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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![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith 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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![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough 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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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter 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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![weight loss, diabetes, insulin pen-GettyImages-2196049931]( "FDA Cracks Down On GLP-1 Imports")
FDA Cracks Down On GLP-1 ImportsGLP-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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PSC Biotech Partners With UVD Robots To Bring Autonomous UV-C Disinfection Technology To Drug Manufacturing3/26/2026
PSC Biotech is proud to partner with UVD Robots, part of Blue Ocean Robotics, to bring autonomous UV-C disinfection technology to pharmaceutical and life sciences facilities across the United States, Australia, and Singapore.
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TerraPower Isotopes Announces Plans To Build New cGMP Drug Manufacturing Facility In Philadelphia3/23/2026
TerraPower Isotopes® (TPI®) announced today that the company is building its flagship current Good Manufacturing Practices (cGMP) actinium-225 (ac-225) manufacturing facility in the Bellwether District of Philadelphia, Pennsylvania.
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Axplora Announces $60 Million High Potency API Manufacturing Facility Expansion In Italy3/17/2026
Axplora, a global leader in complex active pharmaceutical ingredient (API) manufacturing, today announced a major milestone in its $60 million investment programme in highly potent API (HPAPI) manufacturing at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-storey R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale.
