FEATURE ARTICLES
U.S. Pharmacopeia General Chapter <665> went into effect May 1. One expert explains why complex bioprocessing equipment trains present a greater obstacle than you might think.
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance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
- Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
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Context-First Data For Trustworthy AI In BiopharmaBridge the gap between AI experimentation and enterprise value. Learn how capturing structured, semantically rich data at the point of origin builds regulator-credible AI pipelines.
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Standardized Extraction Protocol Per USP <665>: Bridging Regulatory Expectations And Industry Best Practices4/29/2026
View how to implement USP <665> extractables testing, align with global E&L standards, and apply risk-based strategies to ensure regulatory compliance and patient safety.
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Safe Syringe Solutions For Lipid Nanoparticles7/1/2026
Prefilled syringes improve lipid nanoparticle dosing accuracy and administration. Advanced containment solutions with cross-linked coatings preserve stability and accelerate development timelines.
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A Complete Guide To Capsule Checkweighing5/2/2025
Understand why accurate capsule weighing is essential for therapeutic efficacy, safety, and adherence to pharmaceutical manufacturing standards.
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Digital Maturity In Life Sciences Quality And Manufacturing6/17/2025
Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.
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Mixing Technologies For The Production Of Low To High Viscosity Adhesives4/28/2026
Understand how high shear and planetary mixing technologies optimize adhesive production. Learn to reduce cycle times, eliminate defects, and balance efficiency with your specific viscosity needs.
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NEWSLETTER ARCHIVE
- 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
- 06.30.26 -- Building PFMs For Scalable Manufacturing
- 06.30.26 -- From Weighing To X-Ray: Transform Your Quality Control Strategy
INDUSTRY NEWS
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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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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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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.
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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.
