We caught up with Davinder Ramsingh, MD, to talk about the potential of using low-intensity focused ultrasound (LIFU) to open the blood–brain barrier.
- Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
- Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
- The Future Of Cancer Drug Discovery Is Targeted Immune Activation
- Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
- Unpacking The FDA Draft Guidance On Container Closure Systems
- Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
- Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics
- Inquiries In Inhalation, Part 2: Having A Nose For Innovation
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.
Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.
What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.
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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![GettyImages-545581230-lab-research-computer-tablet-teamwork]( "What Capacity And Cost Won't Tell You About A Fill-Finish CDMO")
What Capacity And Cost Won't Tell You About A Fill-Finish CDMOEvaluating fill-finish CDMOs beyond cost and capacity ensures long-term success. Strategic focus on technical depth, scalability, and modern compliance reduces risk.
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![iStock-1205850790-oral-solid-dose-OSD-tablet-capsule-pill]( "Understanding Of Amorphous Solid Dispersions & Their Downstream Development")
Understanding Of Amorphous Solid Dispersions & Their Downstream DevelopmentUnderstanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.
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![GettyImages-1311641109-capsule-tablet-pill-OSD-oral-solid]( "Capsule Formulation Development: From Dosage Forms To Filling")
Capsule Formulation Development: From Dosage Forms To FillingCapsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.
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![GettyImages-471887979-pediatric-kids-eye-exam]( "Formulation Considerations For Pediatric Populations")
Formulation Considerations For Pediatric PopulationsBy partnering with a CDMO with experience in pediatric formulation, pharmaceutical companies can increase acceptability of their drugs among pediatric patients.
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![GettyImages-1288978528 Scientist Using Microscope In Lab]( "A New Framework For Identifying Nitrosamine Risks And Derisking Products")
A New Framework For Identifying Nitrosamine Risks And Derisking ProductsExamine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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![smartphone]( "Why Connect An Auto-Injector To A Smartphone?")
Why Connect An Auto-Injector To A Smartphone?Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not?
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![Scientists Mixing Solution In Lab GettyImages-1443286944]( "Formulation Development For Injectables")
Formulation Development For InjectablesA uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.
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![Ozempic Insulin injection pen for diabetics-GettyImages-2112991930]( "Decoding the FDA Guidance on Essential Drug Delivery Outputs")
Decoding the FDA Guidance on Essential Drug Delivery OutputsThe FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.
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Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges
An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.
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![BO 1 - GCApp_clemex (both machines with person)]( "Is It Ever Too Soon To Start Your Performance Testing Assessment?")
Is It Ever Too Soon To Start Your Performance Testing Assessment?Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.
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]( "Unpacking The FDA Draft Guidance On Container Closure Systems")
Unpacking The FDA Draft Guidance On Container Closure SystemsIn this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
FREE EBOOK
Why Human Factors Are Critical To Drug Delivery Device Success
In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.
This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.
