FEATURE ARTICLES
While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.
- Why Contamination Control By Design Should Matter To Your CDMO
- Closing The MES Value Gap: Why Technology Isn't The Problem
- Makary's Exit Raises New Questions About FDA Stability And Direction
- Why Isolators Do Not Automatically Ensure Annex 1 Compliance
- Why Are Life Science Companies So Poorly Prepared For RIM's Future?
- [Video] Get It Right with The Gemba
- April 2026 — CDMO Opportunities And Threats Report
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1783586499 regulatory compliance]( "GMP Calibration Management")
GMP Calibration ManagementLearn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
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Smart Manufacturing: A Strategic Imperative For Pharma's Future1/15/2026
Pharmaceutical manufacturing is evolving rapidly. Find out how digital technologies like AI, digital twins, and software-defined automation are driving smarter, more agile production.
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Standardized Extraction Protocol Per USP <665>: Bridging Regulatory Expectations And Industry Best Practices4/29/2026
View how to implement USP <665> extractables testing, align with global E&L standards, and apply risk-based strategies to ensure regulatory compliance and patient safety.
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Isolators For Pharmacy Compounding – Time For Change?3/14/2025
Maintaining a contamination-free environment is crucial in drug compounding. Learn how isolator systems can improve safety, efficiency, and regulatory compliance.
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Spray Dried Dispersions In Controlled Release Formulations10/16/2025
Integrating spray dried dispersions with CR strategies addresses poor drug solubility and the need for tailored release kinetics. Explore considerations to ensure stability and sustained supersaturation.
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Navigating Digital Transformation For Pharmaceutical CDMOs10/31/2025
Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Seizing The Opportunity To Go Paperless
- Overcoming Food Effects, Variability, Solubility For A Non-Opioid Analgesic With Lipid-Based Formulations
- X-Ray Inspection For Supplement Safety
- Leveraging A Modern HPLC System For Peptide Drug Substances Analysis
- Lyophilization To Enable Drug Products Containing Labile Molecules
NEWSLETTER ARCHIVE
- 05.21.26 -- Gaining An Edge In GLP-1 Production
- 05.21.26 -- STREAM Edition: Regulatory Gaps And Inspection Readiness
- 05.20.26 -- Smarter Pharmaceutical Packaging Strategies
- 05.20.26 -- Mixed Up? Everything You Need To Know From The Mixing Experts
- 05.19.26 -- How Rheology Strengthens Every Stage of Pharma Development
INDUSTRY NEWS
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![rating service, satisfaction-GettyImages-2221603596]( "ISPE Announces 2026 FOYA Winners")
ISPE Announces 2026 FOYA WinnersThese awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
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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.
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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Inside Information: Nanoform Signs First Exclusivity Agreement For Ultra-High Concentration Subcutaneous Delivery5/12/2026
Helsinki, Finland – Nanoform Finland Plc (“Nanoform”), the medicine performance‑enhancing company, today announced that it has signed an exclusivity agreement with a U.S. biopharmaceutical company (Nasdaq listed, Mcap USD 1Bn+) for the application of Nanoform’s proprietary biologics nanoparticle technology to support the development of differentiated subcutaneous biologic medicines.
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Compact & Powerful Double Planetary Mixer For Lab And Pilot-Scaling4/30/2026
ROSS has delivered an ergonomic and powerful Double Planetary Mixer Model DPM-10 engineered for high-viscosity and specialty material processing in laboratory and pilot-scale operations.
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AES Cleanroom Technology appoints John Groth As Chief Revenue Officer4/27/2026
AES Cleanroom Technology, a leading provider of modular cleanroom design, manufacturing, and construction solutions for the life sciences and biopharmaceutical industries, has appointed John Groth as Chief Revenue Officer as demand grows for flexible, high-performance manufacturing environments across pharma and biotech.
