FEATURE ARTICLES
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
- DEA Reveals Hidden Costs Of Analytical Validation Guidelines
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- Why CMC Tech Transfer Should Begin With The End In Mind
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- August 2026 — CDMO Opportunities And Threats Report
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
PHARMA ONLINE WHITE PAPERS
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![GettyImages-2158862132-vials-robotic-arm-filling-liquid-handling-lab]( "Aseptic Process Design And Simulation Under Annex 1 Guidelines")
Aseptic Process Design And Simulation Under Annex 1 GuidelinesGain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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The Strategic Value Of In-House Delumping For Homogeneous API Production9/9/2026
API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.
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Inline Checkweighing Of Packaged Products In Manufacturing12/29/2025
Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.
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Advancing QC Efficiency With SEC-MALS System And Empower Software7/31/2025
Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.
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A Shift Towards Biofluorescent Particle Counters In Manufacturing5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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The 5 Ws Of A Human Factors Strategy3/31/2025
A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 10.08.26 -- What Does Digital CMC Maturity Look Like?
- 10.08.26 -- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
- 10.08.26 -- Regulatory Gaps And Inspection Readiness
- 10.07.26 -- New Insights On Advancing AAV Development And Beyond
- 10.06.26 -- The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem
INDUSTRY NEWS
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![white coupon banner, great topic-GettyImages-2271702407]( "Let Your Voice Help Shape Pharma Manufacturing")
Let Your Voice Help Shape Pharma ManufacturingPharmaceutical Online hosts live virtual panels with industry experts on important topics and challenges, and we want to know what topics are important to you. Please consider taking a few minutes of your time to tell us what they are.
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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.
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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Contec Launches Sterile ReadySAT™ With PeridoxRTU® Sporicidal Wipes For Cleanrooms10/7/2026
Contec, Inc. announces the launch of sterile ReadySAT™ with PeridoxRTU® Sporicidal Wipes. Validated sterile and suitable for ISO 3-8 cleanrooms, the wipes support surface disinfection in the most critical cleanroom environments.
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Upperton Unveils New Brand Identity Reflecting Evolution Into Specialist CDMO10/6/2026
Upperton has unveiled a new brand identity at CPHI Milan, marking a significant milestone in the company's evolution into a specialist, end-to-end contract development and manufacturing organisation (CDMO) focused on solving the challenges of molecule development across oral, nasal, pulmonary and parenteral dosage forms.
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Hovione To Commission World's First ConsiGma® CDC Flex, Bringing Next-Generation Continuous Tableting To The U.S.10/5/2026
Hovione, a globally integrated pharmaceutical contract development and manufacturing organization (CDMO), today announced it will commission the world’s first ConsiGma® CDC Flex – a next generation continuous tableting line – at its East Windsor, New Jersey campus in late 2027. The line will be installed at 89 Twin Rivers, Hovione's recently opened facility, expanding the company´s drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the U.S.
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Agilent Expands Oligonucleotide Manufacturing Capabilities With New Boulder Lab10/5/2026
Agilent Technologies Inc. (NYSE: A) today announced the addition of new laboratory space in Boulder, Colorado, to support the expansion of its oligonucleotide manufacturing capabilities. The facility is expected to support the development and scale-up of emerging manufacturing technologies for oligonucleotide therapeutics, initially focusing on enzymatic ligation.
