FEATURE ARTICLES
In 2025 alone, Lilly announced plans to build new facilities in Texas, Alabama, Virginia and Pennsylvania in addition to facility expansions in Indiana, Wisconsin and Puerto Rico.
- Solving The Top 3 Pharma Packaging/Manufacturing Issues
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- Novo's Path To The First GLP-1 Weight Loss Pill
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- December 2025 — CDMO Opportunities And Threats Report
- 5 FDA Approval Categories In 2025
PHARMA ONLINE WHITE PAPERS
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![GettyImages-931069642 mAb, monoclonal antibodies]( "Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody Derivatives")
Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody DerivativesDue to the complexity of bispecifics, Fc-fusion proteins, and Fab fragments, their manufacturing poses added purification challenges and requires a robust toolkit of purification techniques.
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Harnessing Chemistry For Scalable Manufacture Of Lipids Used In mRNA Delivery1/28/2025
Discover how scalable lipid nanoparticle (LNP) technology is revolutionizing mRNA-based therapies and shaping the future of treatment innovation.
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Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies5/5/2025
Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.
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Developing Pulmonary Dosage Forms For Complex Molecule Delivery9/23/2025
Discover how next-generation inhalation technologies can transform pulmonary drug delivery and unlock new therapeutic possibilities for a wide range of respiratory diseases.
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Accelerated API Manufacturing: Combining All Process Development Stages5/16/2024
During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.
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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.
PHARMA ONLINE APP NOTES & CASE STUDIES
- HILIC Method Migration Part 2: Troubleshooting Peak Splitting Of Cetirizine
- Method Migration Of A Normal Phase HPLC Method For Tocopherols
- Comparison Of Single-Use And Steel Fermentors For Malaria Vaccine Production
- Enhanced Validation Data Anti-EGFRvIII Recombinant Antibody
- Scaling And Migration Of A HILIC Method For Related Compounds Of Ribavirin
NEWSLETTER ARCHIVE
- 02.14.26 -- Pharmaceutical Online Best Of January
- 02.13.26 -- It's Copy/Paste In Fleet Management Manufacturing
- 02.13.26 -- Smarter Pharma Production Starts Here: Automation, Efficiency & Speed
- 02.12.26 -- STREAM Edition: Data Governance And Regulations For AI Use In GMP With Peter Baker
- 02.11.26 -- Sharpen Your Chromatography Performance
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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JHS CEO Chris Preti Receives 2026 Person Of Influence Award2/12/2026
Spokane, WA. - The Spokane Journal of Business named Chris Preti, CEO of Jubilant HollisterStier (JHS), as one of its 2026 People of Influence.
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Subcutaneously Administered Nanotrastuzumab Matches Performance Of Herceptin HYLECTA In Minipig Study2/12/2026
Nanoform Finland Plc, the medicine performance-enhancing company, announced the results from a preclinical study designed to compare the tolerability and pharmacokinetics of Nanotratsuzumab, a nanoformed, novel, hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab for subcutaneous delivery versus Herceptin HYLECTA™, a co-formulated product with Halozyme’s proprietary hyaluronidase enzyme marketed by Roche/Genentech.
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A New Chapter In ROIS Commercial Leadership2/11/2026
ROIS today announced the appointment of Kimberlee Steele as Chief Commercial Officer, effective from 1 March 2026.
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New AI Solution From Catalyx Slashes Line Clearance Time And Boosts Manufacturing Efficiency2/10/2026
With production bottlenecks costing life sciences manufacturers millions in lost productivity, Catalyx today unveiled OpenLine LineClearance Assistant™ 3.0, a breakthrough AI-powered solution addressing this issue. The new solution transforms line clearance into a fully automated digital process, accelerating product changeover time, minimizing downtime, and maximizing operational efficiency.
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KeyPlants AB Expands Production Capacity With New Facility In Götene, Sweden2/9/2026
KeyPlants AB is strengthening its global production capacity through a significant expansion into Götene, Sweden. In response to a recently secured large-scale order and an increasingly strong project pipeline, the company is establishing operations at the Götenehus industrial site under a four-year lease agreement with Forshem Fastigheter.
