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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Extended Head Flats Increase Dwell Time
Explore the extended head flat and how this punch modification can improve the compression of difficult formulations.
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Change Management In Pharmaceutical Quality Control Laboratories10/29/2024
Gain expert insights into the driving forces behind change management, the associated obstacles within a QC lab, and best practices for guiding change when implementing new technology or procedures.
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Three Key Actions To Minimize Dead Volumes10/10/2025
Minimizing liquid dead volume helps labs conserve costly reagents and scarce samples while boosting assay throughput. Learn how advanced liquid level detection technologies are driving efficiency.
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Continuous Flow — An Emerging Alternative5/16/2024
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
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Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes4/8/2025
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
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Exploring The Future Of Viral Vector Development And Production1/17/2024
The demand for viral vectors continues to grow, making addressing the challenges related to their manufacturing and scale-up increasingly critical.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Cell Therapy Facility For DTM At NIH Clinical Center
- 3D Neurospheres In Healthy And Alzheimer's: iPSC-Derived Neurons
- Analysis Of Azithromycin: System Performance Under Challenging Conditions
- Migrating Peptide Mapping Methods With Innovative Technology
- Comparative Study On Secondary Contamination Risk
NEWSLETTER ARCHIVE
- 12.04.25 -- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- 12.04.25 -- STREAM Edition: Quality Control Failures And Solutions
- 12.03.25 -- 3D Printing, Smart Packaging, And The Future Of Drug Delivery
- 12.02.25 -- Solve High-Viscosity Challenges: Predictive Modeling Approaches & Data-Driven Insights
- 12.02.25 -- 9 Drugs Granted Fast Track By FDA's Voucher Program
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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Quotient Sciences And Intrepid Labs Form Strategic Partnership To Accelerate AI-Guided Formulation Development12/4/2025
Under the new agreement, Quotient Sciences will have access to Intrepid’s machine learning model, ANDROMEDA, the first AI platform to develop and optimize clinical performance of drug products. The platform is designed to significantly reduce formulation development timelines, reduce API demands and increase formulation understanding, helping clients reach critical milestones faster and improve confidence in clinical success.
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Large-Capacity Double Planetary Mixer Ideal For Highly Viscous Materials11/26/2025
ROSS recently completed the largest Double Planetary Mixer in its US history, a Model DPM-750 capable of mixing up to an impressive 750 gallons per batch and engineered with safety features for a Class I, Division 1, Group D hazardous environment. This heavy-duty mixer delivers the robust agitation required for ultra-high viscosity materials while adhering to demanding safety standards.
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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.