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
Learn how advanced containment solutions support high-viscosity biologics, improve device compatibility, enhance injection performance, and address evolving drug delivery and patient care challenges.
Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.
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.
See how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
Is Your Combination Product Drug-Led Or Device-Led?The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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![iStock-1087218874]( "Improved Biomanufacturing Processes And Drug Product Stability")
Improved Biomanufacturing Processes And Drug Product StabilityImprove upstream media for bioavailability and foam stability, downstream buffers for purification, and the formulation and final fill drug product stability with this highly interdisciplinary process.
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![iStock-1268181219-glass-vial-packaging-sterile]( "Container Closure Integrity: A Risk-Based Approach")
Container Closure Integrity: A Risk-Based ApproachContainer closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.
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![GettyImages-1314459863-OSD-manufacturing-pill-tablet-capsule]( "Partnering For Success In Sustained Drug Delivery Formulations")
Partnering For Success In Sustained Drug Delivery FormulationsWith a focus on the sustained and controlled drug delivery segment of the pharmaceutical market, learn about technology platforms, support services, and sustainable solutions.
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![BD2]( "Leveraging Autoinjector Innovation To De-Risk Biosimilar Development")
Leveraging Autoinjector Innovation To De-Risk Biosimilar DevelopmentDiscover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.
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![West-1]( "Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products")
Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination ProductsAs the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.
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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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![GettyImages-1346739457-environmental-sustainability-pill-tablet-capsule-OSD-green]( "Reducing Environmental Impact At All Stages Of The Medicine Journey")
Reducing Environmental Impact At All Stages Of The Medicine JourneyExplore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.
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![GettyImages-950086574-oral-solid-OSD-pill-tablet-capsule-development]( "Platform Reduces Product Development Time And Cost By 30%")
Platform Reduces Product Development Time And Cost By 30%Using innovative capsule-filling equipment and processing technology, and mini-tablet and drug-layered beadlet manufacturing, you can have an adaptable, easily modified formulation.
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![West Pharma - Article 1 - 4040-40 Lyotec 13mm 20mm Group V2]( "Stopper Functionality – Key Considerations")
Stopper Functionality – Key ConsiderationsWhen selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.
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.
