FEATURE ARTICLES
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
- A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
- Tackling OSD Manufacturing Challenges With Pharma 4.0 Digital Innovation: Overview
- At Base Camp: Lilly's Manufacturing Capacity Journey
- The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
- January 2026 — CDMO Opportunities And Threats Report
- Solving The Top 3 Pharma Packaging/Manufacturing Issues
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1600719545 lab]( "Why Biopharma Breakthroughs Aren't Moving The Market")
Why Biopharma Breakthroughs Aren't Moving The MarketBiopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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Generate CHO-K1 GFP-Expressing Cells For Cell Line Development Workflow11/7/2025
Discover 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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Developing Effective Procedures10/21/2024
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
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FDA's Regenerative Medicine Advanced Therapy (RMAT) Program12/10/2025
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.
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Reducing ADC Timelines With Integrated Development And Manufacturing4/8/2024
ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.
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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.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Jaw Crimping vs. Rotary Crimping: Enhancing Aseptic Assurance
- Overcome Common Pre-Filled Syringe Challenges Through Partnership
- Predicting Human Liver Damage With A More Accurate In Vitro Hepatotoxicity Assay
- 2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance
- Simplify Process Scale-Up With An Innovative Single-Use Bioreactor
NEWSLETTER ARCHIVE
- 02.21.26 -- Aseptic Contract Manufacturing Services
- 02.20.26 -- Lessons In Quality From Sanofi's Plai.qa
- 02.19.26 -- STREAM Edition: Regulatory Guidance For Cleaning And Disinfecting
- 02.18.26 -- How To Break Through Fill/Finish Bottlenecks
- 02.17.26 -- Solving The Top 3 Pharma Packaging/Manufacturing Issues
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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Johnson & Johnson Announces $1 Billion Investment With New Cell Therapy Manufacturing Facility In Pennsylvania2/22/2026
ohnson & Johnson (NYSE: JNJ) (the “Company”), healthcare’s leading, most comprehensive innovation powerhouse, today announced a more than $1 billion investment in a next generation cell therapy manufacturing facility in Montgomery County, Pennsylvania. This new facility will further expand the Company’s U.S. manufacturing capacity as it advances its industry leading portfolio and pipeline of transformational medicines for cancer, immune-mediated and neurological diseases.
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Syntegon Launches AIM9 High-Speed Inspection Platform2/18/2026
Based on decades of experience and proven technology, Syntegon is launching the AIM9 inspection platform. It combines visual inspection and leak detection with outputs of up to 600 vials per minute, helping pharmaceutical manufacturers and CMOs achieve the highest inspection and product quality.
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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.
