FEATURE ARTICLES
Three experts—Doug Bakan (CTO of Kailera), Hyung Heon Kim (CEO of MetaVia) and Deepa Nagpal (Founder of SygnifyQ)—joined us on Oct. 15, 2025, to explore this topic, find out the most common quality failures, learn what innovation is occurring and find out what business decisions can help support both quality and quantity.
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- ISPE Awards 8 Innovative Pharma Facilities
- The Transition To E-Labeling Is More Than Uploading PDFs
- Are You Still Evaluating CMOs When You Really Need A CDMO?
- Program Manager Alignment And Integration: Best Practices When Working With A CDMO
- New Guide Aims To Build Robust Framework For Digital Validation Tools
- 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing
PHARMA ONLINE WHITE PAPERS
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![GettyImages-959950866-Nasal Spray Bottles]( "In Vivo Testing Of Nasal Dosage Forms")
In Vivo Testing Of Nasal Dosage FormsInnovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.
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Understanding Biosafety Levels5/20/2024
Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.
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Opportunities In Preclinical Development11/4/2024
Every domain produces critical data and this data and contexual information should be captured and managed in the most effective and robust manner.
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Compound Library Consortium5/16/2024
Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.
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GMP Calibration Management8/8/2025
Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
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Next Generation Sequencing In Viral Safety Testing7/25/2025
Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.
PHARMA ONLINE APP NOTES & CASE STUDIES
- The Most Significant Quality Measurement For Manufacturers
- Biosensors For Rapid And Direct Quantitation Of AAV Capsids
- Cell Culture Media Filtration: Evaluating Cell Culture Performance
- Rapidly Assess Drug Response In 2D And 3D Breast Cancer Model Systems
- Rapid, Automated, At-Line Adenovirus Quantitation
NEWSLETTER ARCHIVE
- 11.04.25 -- Achieve Peak Performance With PCD Solutions
- 11.01.25 -- Master Pharmaceutical Quality Assurance With Expert Solutions And Support
- 10.31.25 -- From Lab to Plant: Managing Operational Environment During Scale-Up
- 10.30.25 -- Innovation Spotlight: Smarter, Faster, More Flexible Bioprocessing
- 10.30.25 -- The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma
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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CDMO Codis Launches As Commercial Spray Drying And Amorphous Solid Dispersions Provider10/31/2025
Codis officially launches as a new global CDMO specializing in commercial-scale spray drying, amorphous solid dispersions (ASD), and particle engineering technologies. Formed through the integration of Particle Dynamics in the US and the Haverhill, UK spray drying facility previously operated by EUROAPI, Codis combines decades of regulatory expertise and manufacturing strength under one brand.
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Eli Lilly Announces $1.2 Billion Investment To Expand Puerto Rico Manufacturing Site For Next-Gen Oral Medicines10/30/2025
Eli Lilly and Company (NYSE: LLY) announced today a planned investment of more than $1.2 billion to expand and modernize its Lilly del Caribe manufacturing site in Carolina, Puerto Rico. This new investment will integrate advanced technologies and expand production capacity within the existing campus to support the company's growing portfolio of oral solid medicines in cardiometabolic health, neuroscience, oncology and immunology.
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Apeloa Successfully Passes 20th FDA Inspection With No Action Indicated10/30/2025
Following a rigorous and comprehensive evaluation process, Apeloa Pharmaceutical has successfully passed its 20th US FDA inspection, a top achievement in the industry that underscores Apeloa’s exemplary quality and management standards.
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Tema Sinergie Acquires Majority Stake In Aseptic Filling OEM 6Bio10/29/2025
TEMA Sinergie S.p.A., a global leader in isolation systems for the Radiopharma and Biotech Pharma industries, today announced the acquisition of a majority stake in 6Bio, a Spanish company specialized in high-performance aseptic filling technology.
