Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
- What Patients Actually Want From Connected Drug Delivery
- Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery
- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
- From Albumin To Oncology: Can Chemical Engineering Unlock Solid Tumor Delivery?
- A Practical Framework For Selecting Long-Acting Injectable Platforms Across Therapeutic, Product, And Delivery Constraints
- Using Low-Intensity Focused Ultrasound To Open The Blood–Brain Barrier
- Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals
- Oral Combination Therapies: Navigating Development Complexities
ON-DEMAND WEBINARS
Nanoparticle engineering enabled a 440 mg/mL trastuzumab suspension that clears viscosity and stability barriers limiting conventional high-dose subcutaneous biologics formulations.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![GettyImages-525440891-lab-research-development]( "Making The Right Choice For Multiparticulate Modified Release Dosage Forms")
Making The Right Choice For Multiparticulate Modified Release Dosage FormsWurster processing is a versatile pharmaceutical development and manufacturing technique for multiparticulates in modified release dosage forms. Understand if it's the right method for your modified-release project.
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![Image 2]( "Establishing A Container Closure System — Engineering For Integrity")
Establishing A Container Closure System — Engineering For IntegrityCCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.
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![GettyImages-1281923833-oral-solid-OSD-pill-tablet-capsule-manufacturing]( "How Various Clinical Study Stages Influence Oral Formulation Approach")
How Various Clinical Study Stages Influence Oral Formulation ApproachIt’s important for pharmaceutical and biopharmaceutical companies to implement a phase-appropriate approach for early formulation development and later-stage commercial development.
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![injectables-regulatory-GettyImages-2248556042]( "The Regulatory Compass Driving Drug Delivery Innovation")
The Regulatory Compass Driving Drug Delivery InnovationRegulatory requirements are growing more complex. Discover how strategic planning, regulatory intelligence, and platform approaches can streamline development and approvals.
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![iStock-1140779754-lab-team-research-equipment]( "Stability Chambers: Testing, Equipment, And Uses")
Stability Chambers: Testing, Equipment, And UsesPerforming stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "Safe Syringe Solutions For Lipid Nanoparticles")
Safe Syringe Solutions For Lipid NanoparticlesPrefilled 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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![respiratory]( "Trends In Combination Products")
Trends In Combination ProductsAs demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.
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![GettyImages-1388184871-quality-compliance-approval]( "From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation")
From Regulators To PUPSIT: Notes On Annex 1 Revision ImplementationKevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.
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![GettyImages-2002525379-production-solid-dose-capsules]( "Patient Adherence With A Novel Dosage Form")
Patient Adherence With A Novel Dosage FormA sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.
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.
