FEATURE ARTICLES
What do you do when tasked with producing drugs of different molecular sizes, including highly potent compounds, in the same facility on a global scale? You tap technological advances in automation, modular design for flexibility, and tie it together with systems that enable real-time data.
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
- What Reliance, Annex 1, And AI Mean For The Future Of GMP
- Applying Contamination Control By Design: A Practical Guide For CDMOs
- Navigating Rough Pharma Seas With Collaboration
- Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit
- Rethinking CQV In A Digital, Agile Manufacturing Landscape
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
PHARMA ONLINE WHITE PAPERS
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![glass-vial-liquid-samples-GettyImages-849081626]( "Vial Breakage During Lyophilization: Root Causes And Mitigation")
Vial Breakage During Lyophilization: Root Causes And MitigationLearn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
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Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility10/16/2024
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
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History Of Peptides In Medicine: From Early Chemistry To The GLP-1 Era4/21/2026
Peptide therapeutics from early chemical breakthroughs to today’s metabolic drugs, highlighting scientific, clinical, and manufacturing advances shaping modern drug 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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FDA's Regenerative Medicine Advanced Therapy (RMAT) Program12/10/2025
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.
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Spray Dried Biologics For Pulmonary Dosage Forms5/15/2026
Spray drying creates stable inhalable biologic powders with controlled particle size, enabling effective lung delivery, improved stability, and scalable production for respiratory and systemic therapies.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission
- Measuring AAV Vector Genome Titer Using Droplet Digital PCR Protocol
- TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
- Meeting Annex 1: A Proactive Approach To Regulatory Compliance
- Leverage Apps To Reduce Line Changeover Time From 14 Days To 3
NEWSLETTER ARCHIVE
- 06.02.26 -- Navigating Combination Product Development For Novel Biologics
- 06.02.26 -- Why Are Life Science Companies So Poorly Prepared For RIM's Future?
- 06.01.26 -- Advancing Pharma Packaging, Inspection And Drug Delivery
- 05.30.26 -- Aseptic Manufacturing Product Showcase
- 05.29.26 -- Smarter Pharma Software Starts Here
INDUSTRY NEWS
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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.
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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
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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Veranova Appoints Dr. Bob Huang Vice President And General Manager Of West Deptford Site6/3/2026
Veranova today announced the appointment of Dr. Bob Huang as Vice President and General Manager for its West Deptford, New Jersey facility. He will lead site operations, advance strategic growth initiatives, and strengthen manufacturing excellence and customer delivery.
