FEATURE ARTICLES
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
- ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
- 4 Ways To Build 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
PHARMA ONLINE WHITE PAPERS
-
![clinical-trial-supply-challenges-GettyImages-2161372208]( "The Role Of Processing And Supplier Diversification")
The Role Of Processing And Supplier DiversificationOptimizing UHMWPE implants requires balancing materials, processing, and sourcing to improve performance, reduce risk, and lower costs in medical device manufacturing.
-
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.
-
A Risk-Based Approach To Plasmid DNA And mRNA Process Development9/23/2025
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
-
Streamlining Early Drug Development: Efficient Synthesis Of Highly Potent Compounds5/6/2026
Discover how risk‑based, phase‑appropriate synthesis enables safe, efficient production of highly potent compounds while balancing speed, worker safety, and regulatory readiness in early development.
-
Process Analytical Technology In The ADC Bioconjugation Process4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
-
White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges10/16/2024
Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 10.01.26 -- Rethinking API Manufacturing: The Why, Benefits And Challenges
- 09.30.26 -- From Nanomedicine To Manufacturing: New Insights From Ardena
- 09.30.26 -- Fill/Finish Robotics Are Reshaping Aseptic Manufacturing
- 09.29.26 -- You Can't CAPA What You Can't Classify
- 09.29.26 -- Highlighting 50 Years of Excellence
INDUSTRY NEWS
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
METTLER TOLEDO Expands Foreign Material Re-Inspection Services With New Dallas Facility9/30/2026
METTLER TOLEDO announced today that its new X-ray Reclaim Foreign Material Re-inspection Services facility in Dallas, Texas, is scheduled to open on October 5, 2026.
-
Serán Bioscience Strengthens Spray Dry Capabilities With Growth Investment From Biospring Partners To Accelerate Commercial Expansion And Meet Surging Customer Demand9/30/2026
Serán Bioscience (“Serán” or “the Company”), a leading contract development and manufacturing organization (CDMO) specializing in development, analytical and manufacturing solutions to pharmaceutical and biotechnology companies, today announced a growth investment led by Biospring Partners with continued participation from existing investors Vivo Capital, Bain Capital Life Sciences (“Bain Capital”), as well as Serán’s executive leadership.
-
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."
-
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.
-
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.
