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- Unpacking The FDA Draft Guidance On Container Closure Systems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
Explore an integrated workflow for targeted lipid nanoparticle development, covering ligand conjugation, candidate screening, and scalable manufacturing for cell-specific nucleic acid delivery.
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1294339670-lab-cleanroom-PPE-computer-team]( "Recent Innovations And Enhancements To Pharmaceutical Spray Drying")
Recent Innovations And Enhancements To Pharmaceutical Spray DryingFinding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.
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![GettyImages-1156884561-fill-finish]( "Key Considerations For Selecting Flexible Fillers")
Key Considerations For Selecting Flexible FillersFlexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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![GettyImages-1330728771-microscope-lab]( "De-Risking Visible Particles Through Component Selection")
De-Risking Visible Particles Through Component SelectionExplore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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![GettyImages-1097562996-pill-tablet-capsule-OSD-oral-solid]( "Patient-Centric Formulations In Pediatric Adherence")
Patient-Centric Formulations In Pediatric AdherenceImproving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help overcome barriers and support safer, more effective therapies for children across developmental stages.
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![iStock-842481112-child-medicine-tablet-capsule]( "Age-Appropriate Pediatric Formulation Development")
Age-Appropriate Pediatric Formulation DevelopmentThere is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.
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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).
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![West feature]( "Reducing Lead Time & Optimizing Costs")
Reducing Lead Time & Optimizing CostsExplore how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed to market.
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![GettyImages-1543830891-direct-to-patient-cell-medicine-order-medication]( "PHI And Medical Devices: What Device Manufacturers Need To Know")
PHI And Medical Devices: What Device Manufacturers Need To KnowConnected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.
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![GettyImages-1351604433 freezing]( "Lyophilization: Protecting And Preserving Biologics")
Lyophilization: Protecting And Preserving BiologicsDiscover how lyophilization revolutionizes biologic drug manufacturing and ensures potent, stable treatments for complex diseases.
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![Ready-To-Use GLP-1]( "Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs")
Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based DrugsReady-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.
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.
