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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The Impact Of Artificial Intelligence On CQV
AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.
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Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing4/24/2024
Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.
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Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future9/16/2025
See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.
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EMA Support For Rare Disease Therapies6/10/2025
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
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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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The Complete Flow Cytometry Guide9/24/2024
This guide covers the fundamentals of flow cytometry, aiming to help you better understand how it works, when it is most valuable, and how to conduct an experiment.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Asset Reinduction To Maximo EAM, Enabled By Reality Capture
- Scalability From 5L To 50L Using The DynaDrive Single-Use Bioreactor
- Accelerating Bulk Harvest Release Testing With A PCR-Based Solution
- Improving Bioprocess Monitoring And Control With Multivariate Data Analysis
- Development To Large-Scale cGMP Production
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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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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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.