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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![digital key in hand-GettyImages-1312386626]( "Leveraging Life Sciences Data For Intelligent Decision-Making")
Leveraging Life Sciences Data For Intelligent Decision-MakingIndustry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.
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EMA Support For Rare Disease Therapies6/10/2025
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
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Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody Derivatives11/3/2025
Due to the complexity of bispecifics, Fc-fusion proteins, and Fab fragments, their manufacturing poses added purification challenges and requires a robust toolkit of purification techniques.
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Expanding The Viscosity Limits Of Peristaltic Dosing12/17/2025
Discover how innovations in closed-loop control and mechanical design extend peristaltic dosing limits to 2000 cP, maintaining accuracy while preserving the advantages of sterile, disposable paths.
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Accelerating An Innovative High Potency Oncology Therapy To Market5/13/2026
Learn how disciplined containment, proactive risk management, and collaboration accelerate complex oncology programs under tight timelines while protecting quality, safety, and global launch readiness.
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Explosion Protection For Product Inspection Equipment7/10/2026
Discover how understanding hazardous area classifications and compliance requirements can help manufacturers reduce ignition risks, select appropriate equipment, and operate more safely.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation
- Balancing Protein A Resin Cost, Performance, And Productivity
- Fully Automated Cell Culture Passaging And Expansion
- Scaling Cation Exchange And Affinity Chromatography Operations
- Assessing Particle Generation In A Single-Use Mixing System
NEWSLETTER ARCHIVE
- 09.05.26 -- Quality Assurance Product Showcase
- 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
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.
