FEATURE ARTICLES
Transforming the quality culture should include the adoption of software quality engineering (SQE), but what is it, and how can it impact the quality of your products and processes?
- Here's What You Need To Know About The Access Consortium Pathway
- Is Charisma An API?
- Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
- 3 Ways To Deliver A Pharma 4.0 Facility
- How To Improve Sponsor–CMO Collaboration Around Digital Deviations
- Innovation, Growth (and Happiness) Projected for Pharma
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
PHARMA ONLINE WHITE PAPERS
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![Artificial Intelligence (AI) Digital Concept GettyImages-1160995648]( "Expanding Translational Research Concepts With Genedata Profiler")
Expanding Translational Research Concepts With Genedata ProfilerThe biopharma industry leverages Genedata Profiler to integrate, curate, and analyze diverse R&D data, enabling collaborative, compliant, and AI-driven translational research to optimize drug development.
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Best Practices In Commissioning And Qualification7/5/2024
An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
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The Next Leap In Pharma Manufacturing8/8/2025
Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.
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Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization12/2/2024
Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
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Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells6/28/2024
Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
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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.
PHARMA ONLINE APP NOTES & CASE STUDIES
- How To Get Products To Patients Faster With A Connected QMS
- Review Of Applications And Processes In Fixed-Bed Bioreactors
- Advantages Of Spray-Dried Mannitol In Roll Compaction
- Overcoming Excipient Risks And Challenges For Parenteral Formulations
- Overcome Common Pre-Filled Syringe Challenges Through Partnership
NEWSLETTER ARCHIVE
- 11.25.25 -- Considerations In Sterility Testing And Assurance
- 11.24.25 -- Your trusted filters made closer to you – try by yourself!
- 11.21.25 -- Leaders In The Excipient Market: Region And Type
- 11.20.25 -- Optimize Formulation And Integrity Workflows
- 11.20.25 -- 3 [Potential] Solutions To A More Resilient Supply Chain
INDUSTRY NEWS
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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.
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![Dollar Icon from Medical pills-GettyImages-1708867150]( "Oregon Court Upholds Drug Price Transparency Law")
Oregon Court Upholds Drug Price Transparency LawThe law was first enacted in 2018, followed by a lawsuit by Pharmaceutical Research and Manufacturers of America (PhRMA) in 2019, claiming an infringement of free speech for pharmaceutical companies and violation of public property. PhRMA asked the court to bar Oregon from enforcing the law.
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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CSL To Build Out U.S. Plasma Capabilities Through $1.5B Investment11/24/2025
Global biopharma leader CSL (ASX:CSL; USOTC:CSLLY) today announced plans to expand its U.S. presence over the next five years, resulting in approximately US$1.5b in U.S. capital investments. These investments will generate hundreds of high-quality American jobs, strengthen U.S. manufacturing capabilities of plasma-derived therapies (PDTs), and help secure the U.S. medicine supply chain. This reflects CSL’s commitment to meet the growing clinical need for immunoglobulin (Ig) over the long term.
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Equipment Auction Announced For Sutro Biopharma Assets11/24/2025
December 15-16, 2025: Featuring late-model lab, R&D and manufacturing equipment surplus to future needs of Sutro BioPharma: spray dryer, chromatography systems, Westfalia seperators, HPLC’s & more.
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Syntegon Delivers Strong Growth And Margin Expansion In Q3 2025 With Accelerating Pharma Momentum And Profitability Gains Across All Segments11/21/2025
Syntegon Group, a leading strategic partner to the pharmaceutical, biotech, and food industries, continued its strong growth and margin-improvement momentum in the third quarter of 2025, building on a successful first half of the year.
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Novartis To Add Small Molecule & Fill/Finish Capacity With North Carolina Drug Manufacturing Investments11/20/2025
Novartis Gene Therapies, a division of Switzerland-based Novartis, one of the world’s largest pharmaceutical companies, plans to expand in the Research Triangle with $771 million of investments at multiple locations, creating its first biologics drug substance facility in the United States and adding small molecule manufacturing and new fill/finish capabilities.
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Halozyme Completes Acquisition Of Elektrofi, Expanding Breadth Of Offerings In Drug Delivery11/20/2025
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the successful completion of its acquisition of Elektrofi, Inc. ("Elektrofi"), a biopharmaceutical company with a proprietary ultra-high concentration microparticle formulation technology for biologics, branded Hypercon™
