FEATURE ARTICLES
Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
- 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
- Trends In FDA FY 2025 Warning Letters
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1370928101 regulatory compliance]( "ICH Q12 Implementation: Regulatory Intelligence And PACM Agility")
ICH Q12 Implementation: Regulatory Intelligence And PACM AgilityHere, 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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Overcoming Challenges To High-Concentration Formulation Development3/25/2025
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
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Handling Protocols: Key Considerations In The Highly Potent API Market5/12/2025
Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
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Finding An Optimal Harvest Solution By Considering Cost And Sustainability7/10/2024
Choosing the right harvest solution is pivotal in the pursuit of efficient and sustainable bioproduction. Explore the benefits of a single-use centrifuge over traditional depth filtration methods.
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Epigenetics Application Guide10/2/2024
To fully understand biology and disease mechanisms, it is crucial to explore the role of epigenetic factors. Explore how epigenetic regulation works and methods to study these essential components.
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Driving Digital Excellence In Life Sciences7/1/2025
The life sciences industry is rapidly evolving through digital transformation and agility. Discover why embracing modern technologies is essential to thrive in today’s competitive landscape.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Scale-Up Approaches For Culturing Adherent Cells
- Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test
- Ensure Quality Control With Innovative Software
- Leveraging Innovative Analytics To Ensure The Thermal Stability Of mAb Drug Products
- Simplify Process Scale-Up With An Innovative Single-Use Bioreactor
NEWSLETTER ARCHIVE
- 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
- 03.20.26 -- SUS Interchangeability Assessment And Qualification Best Practices
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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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.
