FEATURE ARTICLES
Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.
- Using Digital Platforms To Find Your CDMO
- AI Governance Is Just Like Driving A Race Car
- Controls For Retrieval-Augmented Generation In GxP
- FDA Issues New Guidance On Therapeutic Equivalence
- July 2026 — CDMO Opportunities And Threats Report
- ADC CDMO Selection For Small Biotech
- Implementing AI Solutions In GMP While Managing Risk
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1462147534 manufacturing]( "5 Steps To Design A Microbiological Performance Qualification For Facilities")
5 Steps To Design A Microbiological Performance Qualification For FacilitiesExplore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
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Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC1/21/2026
Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.
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White Paper: Characterization Of Spray Dried Biologics5/7/2025
Discover how spray drying can transform the formulation of complex biologics by improving stability, delivery, and functionality, with insights into the critical techniques and strategies needed for successful development.
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Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators4/28/2025
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
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Implementing Medium And High-Volume Drug Handling And Packaging Programs4/23/2026
Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.
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The Importance Of Quality In Raw Material Selection1/16/2025
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 09.04.26 -- Can U.S. Policy Bring Generic Drug Manufacturing Back Home?
- 09.03.26 -- Compounding Progress: The Engine Behind Faster Biologics Development
- 09.03.26 -- CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
- 09.03.26 -- Clear Data Handoffs And Cross-functional Teams
- 09.01.26 -- Implementing And Optimizing Your eQMS
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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JHS And Altoura Selected For BioTools Innovator VANGUARD Level Up-XR Program8/28/2026
Jubilant HollisterStier(JHS) and Altoura will be of only three company-CDMO pairs participating in the BioTools Innovator VANGUARD Level Up-XR Program.
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Syntegon Launches New Pilot Scale Tablet Coater For Small Batches8/26/2026
Syntegon, a strategic lifecycle partner to the pharmaceutical and biotech industry has expanded its Oral Solid Dosage (OSD) processing portfolio with the Sepion 75. The new pilot-scale tablet coater designed to support manufacturers and CDMOs in handling growing product diversity, smaller and more variable batch sizes, and stricter containment requirements for highly potent active ingredients. The new coater completes the established Sepion series and supports consistent scale-up, faster flexible batch processing, and containment-oriented manufacturing.
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Cambrex High Point Completes FDA, PMDA And TGA PreApproval Inspections, Advancing Commercial Manufacturing Capabilities8/25/2026
Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced the successful completion of three Pre-Approval Inspections (PAIs) at its High Point, North Carolina facility by the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and Australia's Therapeutic Goods Administration (TGA). The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia, establishing the facility as the newest commercial manufacturing site within the Cambrex global network.
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CleanSpace Names Pharma Industry Veteran Will Knapp Midwest Sales Director8/25/2026
Will Knapp joins CleanSpace as Director of Sales for the Midwest, bringing morethan 25 years of pharma facility design, construction, and validation expertise.
