FEATURE ARTICLES
In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.
- Inside Chugai's Digital Infrastructure Strategy
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- What Biopharma Often Overlooks In A Scheduled Shutdown
- [VIDEO] GLP-1 Manufacturing's New Bottlenecks At Multi-Ton Scale
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
- Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed?
- EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class
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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Precision By Design: Drug Innovation Through Structure-Based Drug Design (SBDD)5/6/2026
Leverage structure-based drug design to gain deeper molecular insights, prioritize high-potential candidates, and accelerate your path from discovery to clinic.
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Continuous Flow — An Emerging Alternative3/17/2026
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
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A Decade Of Transforming Pharmaceutical Manufacturing2/25/2026
Modern enzyme engineering, automation, and AI are reshaping therapeutic development — accelerating design, improving efficiency, and enabling faster, more sustainable biopharma manufacturing.
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How The Accelerator™ Drug Development Model Enhances eNPV2/25/2026
Discover how an integrated CDMO and CRO model can accelerate development timelines, add up to $62.9 million in value, and help you maximize long-term pipeline success with a single, streamlined partner.
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Calculating The ROI Of EAM/CMMS For Pharma Manufacturers And CDMOs10/6/2025
Learn how modern EAM and CMMS systems help pharma manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 07.07.26 -- Overcoming Key Bottlenecks In Modern Bioprocessing
- 07.07.26 -- Inside Chugai's Digital Infrastructure Strategy
- 07.03.26 -- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
- 07.02.26 -- EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class
- 07.02.26 -- STREAM Edition: Adjusting Monitoring And Sampling Methods
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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AustinPx Expands KinetiSol™ Technology Commercial Access Through Thermo Fisher Scientific Collaboration6/30/2026
AustinPx, a contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement for orally delivered small molecule drugs, today announced its agreement with Thermo Fisher Scientific’s Patheon pharma services for the installation of AustinPx’s KinetiSol™ Technology equipment.
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Recipharm Invests In U.S. Fill-Finish Infrastructure To Accelerate Biologics Development6/17/2026
Recipharm, a leading global contract development and manufacturing organisation (CDMO), today announced a multi-million-dollar investment in its US operations, strengthening its ability to support pharmaceutical and biotechnology companies with advanced sterile fill and finish services for biologics and advanced therapies.
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Four Myths About Embedded CMOs, Busted6/17/2026
If you’re looking for a contract manufacturer to bring your therapy to market, you’re far from alone. Demand for manufacturing services is shaping the pharma Contract Manufacturing Industry, with analysts predicting a growth rate of nearly 7% per year until 2028.
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Avoiding Recalls: How To Ensure Sterility In Ophthalmic Products6/17/2026
In the wake of several high-profile eye drop recalls, we look at the challenges of achieving sterility in ophthalmic products, the consequences of failing to do so, and how AbbVie Contract Manufacturing ensures product sterility and safety.
