FEATURE ARTICLES
Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- 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- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance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?
PHARMA ONLINE WHITE PAPERS
-
![GettyImages-1472832232 cleanroom]( "Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy")
Activate Advanced Contamination Control Technology To Safeguard Your Cell TherapyThe most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
-
Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes4/8/2025
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
-
The 5-S Philosophy Driving Asymchem's Integrated TIDES Manufacturing6/11/2026
Manufacturing excellence drives complex therapies, with scale, speed, supply resilience, sustainability, and future readiness enabling development to reliable commercial production.
-
Optimal Microbial Sampling Criteria6/24/2025
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
-
The Role Of A Consulting Firm In The IND Process6/10/2025
Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.
-
Patented Process For Intermediates Useful For Deucravacitinib3/13/2026
Discover how this patented synthetic approach to Deucravacitinib intermediates can improve yield, simplify purification, and support scalable, regulatory-aligned manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Seed Train Intensification Using High Cell Density Cryopreservation
- 3D Cell Culture Reveals Undetectable Drug Efficacy In Traditional Systems
- HILIC Method Migration Part 2: Troubleshooting Peak Splitting Of Cetirizine
- Workflow For Chemical Characterization And Database Curation
- Enable Low Volume Delivery Of Proteins In Aqueous Solutions
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
-
![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
-
Amneal's Planned Sterile Facility Creates Opportunity For Aseptic Filling, Isolator, And Automation Suppliers7/8/2026
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced it has been selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA PreCheck Pilot Program for the company's planned sterile manufacturing facility in Brookhaven, New York.
-
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.
-
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.
-
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.
