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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Why Compliance-Driven CDMOs Win Sponsor Contracts
Learn how digital maturity and compliance excellence are reshaping CDMO competitiveness, as well as strategies that strengthen performance and accelerate tech transfers.
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Revolutionizing Drug Discovery From "Undruggables" To AI6/10/2024
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
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A Guide For Quality Professionals In Healthcare And Life Sciences3/14/2025
Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.
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A Strategic Guide For Biotech And Biopharma Leaders5/15/2025
Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.
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Process Analytical Technology In The ADC Bioconjugation Process4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Label-Free Analysis Of Multiple Spheroids In A Matrix
- Advantages Of Spray-Dried Mannitol In Roll Compaction
- Identification Of GLP-1 Analog Oligomeric States Using SEC-MALS
- Comparing Sterility Testing Techniques
- Consistent Improvement In CHO-K1 GS Performance With Efficient-Pro Feed 3 And Efficient-Pro Feed Enhancer
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.