The field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.
- 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
- 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- Unpacking The FDA Draft Guidance On Container Closure Systems
ON-DEMAND WEBINARS
Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.
Explore how our on-body delivery system supports high-volume biologic delivery by balancing usability, patient needs, and sustainability through research-driven design.
Explore how traditional and innovative pharmaceutical packaging formats improve patient adherence, support emerging therapies, and shape the future of drug delivery and treatment outcomes.
‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![SIS_SelfDose_042 _1252_RGB]( "How Subcutaneous Delivery Can Help Patients Manage Chronic Conditions")
How Subcutaneous Delivery Can Help Patients Manage Chronic ConditionsRead more about how to improve your patients’ outcomes, avoid costly delays to launch, and provide a better return on investment.
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![GettyImages-1287840962-modeling-simulation]( "How To Leverage Modeling And Simulation In The Candidate Development Stage")
How To Leverage Modeling And Simulation In The Candidate Development StageModeling and simulation provides another way to predict the clinical performance of a molecule, based on a robust and holistic approach, before investing the required time and money.
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![The Role Of The Contract Manufacturer In Medical Device Development]( "The Role Of The Contract Manufacturer In Medical Device Development")
The Role Of The Contract Manufacturer In Medical Device DevelopmentWith a trusted contract manufacturing partner, pharma companies can ensure that their innovative therapies come to market efficiently without compromising the quality of the drug and its delivery system.
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![West-2]( "The Path To Commercialization For Wearable Drug Delivery Devices")
The Path To Commercialization For Wearable Drug Delivery DevicesExplore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.
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![iStock-1319077865-lab-team-computer-research]( "Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk")
Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower RiskDiscover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
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![MSglassvials]( "Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products")
Supporting Complex Manufacturing For Liquid And Lyophilized Drug ProductsAseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
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![03 West]( "Sample Sizes For Performance Testing Of Combination Products, Packaging")
Sample Sizes For Performance Testing Of Combination Products, PackagingWhen developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
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![iStock-1191189866-lung-inhalation-skeleton-respiratory]( "Expanding Opportunities For Inhaled Drug Delivery")
Expanding Opportunities For Inhaled Drug DeliveryReview the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.
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![INCOG]( "Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing")
Key Financial Considerations For Phase II Clinical Injectable Drug ManufacturingThis article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.
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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.
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.
