FEATURE ARTICLES
This interview with Sai Life Sciences’ Tuneer Ghosh explains why CMC technology transfer should begin with commercialization and lifecycle goals in mind. It highlights how early planning for scale, CDMO involvement, supply resilience, regulatory requirements, process safety, and shared learning can support a smoother, more sustainable transfer.
- August 2026 — CDMO Opportunities And Threats Report
- 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
PHARMA ONLINE WHITE PAPERS
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![GettyImages-614242432-petri-dish-micro-organisms-bacteria]( "Optimal Microbial Sampling Criteria")
Optimal Microbial Sampling CriteriaMicrobiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
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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.
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Why CDMO Performance Drops Exactly When It Matters Most6/15/2026
Programs often stall moving to GMP due to fragmented workflows and knowledge gaps. Aligning teams and integrating development with execution, via continuous data, sustains momentum and reduces risk.
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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.
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Overcoming Challenges To High-Concentration Formulation Development3/25/2025
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
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Unlocking Operational Capacity With Digitalized Cleaning Validation6/2/2026
Digitalizing cleaning validation reduces inefficiencies, strengthens data integrity, and improves audit readiness. See how integrated systems can continuously optimize manufacturing performance.
PHARMA ONLINE APP NOTES & CASE STUDIES
- A Paradigm Shift From Glass Benchtop Bioreactors
- Analysis Of ADCs Using Hydrophobic Interaction Chromatography
- Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals
- Form Fill And Seal Label Applicator For Drug Packaging
- X-Ray Inspection For Supplement Safety
NEWSLETTER ARCHIVE
- 10.01.26 -- Turn Idle Pharma Equipment Into Cost Savings
- 10.01.26 -- Oral Combination Therapies: Navigating Development Complexities
- 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
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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ROSS 600-Gallon ASME Pressure Vessel For High-Pressure Processing10/1/2026
ROSS’s Tank and Fabrication Division is a full service manufacturer of custom pressure vessels, storage tanks and reactors for virtually any application. One example is the pictured pressure vessel with a 600-gallon full holding capacity and rated for 300 psi at 200 F.
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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.
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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.
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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.
