The emergence of antibody–oligonucleotide conjugates (AOCs) addresses delivery issues with huge potential. Let's look at how to approach your development plan with molecular architecture, defining the target product profile, and CQAs.
- The Resurgence Of Fervor For Oral Delivery
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
- What Patients Actually Want From Connected Drug Delivery
- Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery
ON-DEMAND WEBINARS
Spray drying offers a solution to formulation challenges for enhancing the bioavailability of poorly soluble APIs but requires technical capability and operational excellence to accomplish the process successfully.
Learn more about defining the spray drying process with an emphasis on specific enhancements to accommodate scale-up to commercial scale equipment of challenging applications or molecules.
Explore how bioavailability of poorly soluble APIs can be improved and patient compliance enhanced by reducing the size or number of tablets that a patient must take to achieve the required dose.
We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Vials GettyImages-1316775813]( "Four Special Fill/Finish Considerations For Vaccine Production")
Four Special Fill/Finish Considerations For Vaccine ProductionExamine considerations regarding the handling and process for fill/finish to ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost.
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![Evonik]( "Benefits Of Microparticle Technology For Oral Drug Solubility Enhancement")
Benefits Of Microparticle Technology For Oral Drug Solubility EnhancementSpray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.
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![westextractables]( "Extractables And Leachables – Assessing Risk In A Complex Landscape")
Extractables And Leachables – Assessing Risk In A Complex LandscapeIt is not surprising that there is still confusion on the extractable and leachable topic. Guidances, where available, do not give step by step instructions on testing.
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![inject-GettyImages-2283670652]( "What's Next For NAMs? Moving From Barriers To Breakthroughs")
What's Next For NAMs? Moving From Barriers To BreakthroughsThe future of NAMs depends on robust biology, standardized practices, and submission-ready evidence that demonstrates value and strengthens regulatory trust.
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![Singota-DSC03221]( "Developmental Testing Of IV Solutions")
Developmental Testing Of IV SolutionsAs IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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![iStock-1127257350-innovation-ideas-lightbulb]( "Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway")
Innovative Formulation Technologies By 505(b)(2) Regulatory PathwayRevitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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![GettyImages-1002000796-lab-research-scientist-development]( "Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives")
Closing The Duration Gap In FDA-Approved Long-Acting ContraceptivesA gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.
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![pharma-partners-GettyImages-2182052451]( "The Benefits Of Transparent Pricing")
The Benefits Of Transparent PricingStreamline biopharma budgeting and expose hidden contract manufacturing fees. An all-inclusive pricing model ensures predictable partnerships from initial scale-up to commercial approval.
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![Female scientist microscope-GettyImages-1453524892]( "Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products")
Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination ProductsLearn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "How Dermal Delivery Platforms Are Transforming Tomorrows For Patients")
How Dermal Delivery Platforms Are Transforming Tomorrows For PatientsSkin delivery platforms expand therapies by boosting convenience, stability, and adherence. Integrated formulation, device, and manufacturing development is key to confidently scale.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
Container Closure Systems For Biosimilars: Is There Regulatory Difference?In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.
