FEATURE ARTICLES
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
- 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
PHARMA ONLINE WHITE PAPERS
-
The Essential Ingredient For GxP Training Innovation
Advanced learning tools depend entirely on the health of the underlying training matrix. Establish a clean, data-driven framework to reduce compliance risks and recover lost operational hours.
-
Digital CMC Maturity: Rethinking QTTP And Control Strategy9/2/2026
Digital CMC maturity depends on structured, science- and risk-based knowledge. Learn how connecting development, validation, regulatory, and lifecycle information can accelerate timelines.
-
Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future9/16/2025
See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.
-
Epigenetics Application Guide: RNA Modifications9/26/2024
Learn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.
-
Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization12/2/2024
Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
-
History Of Peptides In Medicine: From Early Chemistry To The GLP-1 Era4/21/2026
Peptide therapeutics from early chemical breakthroughs to today’s metabolic drugs, highlighting scientific, clinical, and manufacturing advances shaping modern drug development.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Routine Monitoring Of DNA/mRNA Therapeutics
- Anticoagulant Selection Influences T Cell Purity And Yield In Whole Blood Isolation
- Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test
- Product Recovery Study For Fill Finish Applications
- Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation
NEWSLETTER ARCHIVE
- 09.08.26 -- Accelerating Sterile Drug Product Development
- 09.08.26 -- Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
- 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
INDUSTRY NEWS
-
Let Your Voice Help Shape Pharma Manufacturing
Pharmaceutical 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.
-
ISPE Announces 2026 FOYA Winners
These awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
-
Høeg In, Pazdur Out At The FDA
What 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.
-
9 Drugs Granted Fast Track By FDA's Voucher Program
With 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.
-
Leaders In The Excipient Market: Region And Type
Though 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
-
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.
-
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.
-
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.
-
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.