FEATURE ARTICLES
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
- 4 Ways To Building A Better CMC Tech Transfer
- The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem
- What FDA Inspectors Want From Your OOS File
- AI Fills The Decision-Making Gaps In Process Analytical Technology
- You Can't CAPA What You Can't Classify
- Why Supplier Diversification Doesn't Ensure Supply Safety
- Oral Combination Therapies: Navigating Development Complexities
PHARMA ONLINE WHITE PAPERS
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![GettyImages-178041798 Technician Using Clipboard, Site Survey Concept]( "A Practical Guide To Expanding Across Sites While Staying Compliant")
A Practical Guide To Expanding Across Sites While Staying CompliantStandardizing governance and data foundations is critical for scaling multi-site networks without increasing risk. Learn to leverage reusable validation and harmonized workflows for audit readiness.
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Breaking The GLP-1 Manufacturing Bottleneck: Single Use For Safer Scale Up9/23/2026
Streamline GLP-1 scale-up by replacing heavy container cleaning with single-use powder handling to boost containment and manufacturing capacity.
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If You Can't Win The Game, Change It12/11/2024
Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.
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Isolate Bright GFP-Expressing HEK293 Cells For Cell Line Development Workflow11/7/2025
Explore a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.
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Validation And Qualification Approach In New Annex 1 Revision2/21/2025
The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines1/9/2026
Gain 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.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 09.28.26 -- The Integrated Path To Injectable Success
- 09.25.26 -- What FDA Inspectors Want From Your OOS File
- 09.24.26 -- How Top CDMOs Are Accelerating Speed To IND
- 09.24.26 -- Why Supplier Diversification Doesn't Ensure Supply Safety
- 09.24.26 -- How Emerging Technology Will Reshape Pharma Operations
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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Rottendorf Pharma Is CDMO Leadership Award Winner 20259/28/2026
Thanks to overwhelmingly positive customer feedback, Rottendorf Pharma has been awarded the CDMO Leadership Award 2025 in the category of "Small Molecule Dosage Form - International."
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Top Employer 2025: Rottendorf Pharma Receives International Award9/28/2026
Rottendorf Pharma has been recognized as a Top Employer 2025 in Germany. The Top Employer Institute, headquartered in Amsterdam, has assessed and certified more than 2,400 companies in 125 countries.
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New Gerteis Roller Compactors: Rottendorf Pharma Invests Millions In State-Of-The-Art Technology9/28/2026
Rottendorf Pharma has commissioned a new dry granulation system from Swiss manufacturer Gerteis Maschinen + Processengineering AG at its Ennigerloh site.
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Rottendorf Pharma To Double Long-Term Manufacturing Capacity With New Campus9/28/2026
Rottendorf Pharma has officially begun construction of the Rottendorf Campus in Oelde, Germany, a major investment aimed at expanding manufacturing capacity for the global pharmaceutical industry.
