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
Gain insights into overcoming the challenges in lipid nanoparticle (LNP) formulation, explore critical aspects of the process and analytical development of LNPs, and much more.
Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.
Discover how an integrated ADC strategy addresses containment, analytics, fill-finish, and inspection challenges to improve product protection, process reliability, and delivery performance.
Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![04 West]( "Delivering Market Success For Pharma Partners From Concept To Patient")
Delivering Market Success For Pharma Partners From Concept To PatientThe development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
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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.
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![West-BIO 1 - 88_NovaPureSyringes_0922]( "A Pathway For Regulatory Success For Devices In Combination Products")
A Pathway For Regulatory Success For Devices In Combination ProductsReady to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.
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![Biologics: When Glass Vials Fail At Low Temperatures, Consider A Cyclic Olefin Polymer System]( "When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System")
When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer SystemIf the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.
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![GettyImages-488719432-bilayer-tablet-OSD-oral-solid]( "Customized Release Through Dispersed Dosage Formats")
Customized Release Through Dispersed Dosage FormatsTypically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.
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![istock1087218874-lab-drug]( "Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages")
Lyophilization vs. Liquid Formation: Why Lyo Offers AdvantagesLyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
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![GettyImages-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Streamlining The Path To Market For Generic Drug-Device CombinationsDeveloping g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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![GettyImages-488719432-bilayer-tablet-OSD-oral-solid]( "Bilayer Tablet Manufacturing: An Overview")
Bilayer Tablet Manufacturing: An OverviewBilayer tablets offer a number of benefits for patient care; understanding the challenges that accompany their formulation is key to enabling their successful commercialization.
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![Enabling Long Lasting Clinical Outcomes In Coronary Stenting]( "Enabling Long Lasting Clinical Outcomes In Coronary Stenting")
Enabling Long Lasting Clinical Outcomes In Coronary StentingPolyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).
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.
