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- Unpacking The FDA Draft Guidance On Container Closure Systems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 the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Learn how techniques and innovations in taste masking sensory and performance evaluation can help accelerate your formulation development and confirm desired taste profile.
Explore how PEG selection shapes drug development success by understanding the benefits of expert CDMO partnerships that deliver custom solutions to enhance your small molecule program.
Explore the pros and cons of marketed amorphous solid dispersions with so-far unpublished data as well as a green alternative to ASDs: best-in-class nanotechnology to manufacture nanocrystals.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![Wooden blocks PFAS-GettyImages-2145498657]( "PFAS In Medical Devices: Expert Insights On Frequently Asked Questions")
PFAS In Medical Devices: Expert Insights On Frequently Asked QuestionsWatch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "How Dermal Delivery Platforms Are Transforming Tomorrows For Patients")
How Dermal Delivery Platforms Are Transforming Tomorrows For PatientsSkin delivery platforms expand therapies by boosting convenience, stability, and adherence. Integrated formulation, device, and manufacturing development is key to confidently scale.
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![iStock-1087219198-lab-computer-cleanroom-research-development-production]( "Spray Drying: Advantages And Disadvantages")
Spray Drying: Advantages And DisadvantagesWhen it comes to formulation development, pharmaceutical spray drying is one of the most versatile solutions. Review a detailed look at the steps involved in spray drying and the benefits and downsides.
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![clinical-gap-GettyImages-1027139762]( "Scaling Safe, Consistent Drug Delivery in Modern Care")
Scaling Safe, Consistent Drug Delivery in Modern CareAssistive drug delivery technologies, including wearable injectors, smart infusion systems, and guided delivery tools, help standardize dosing, reduce variability, and expand access across care settings.
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![GettyImages-1002000796-lab-research-scientist-development]( "Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives")
Closing The Duration Gap In FDA-Approved Long-Acting ContraceptivesA gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.
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![West-Vol 7-Blog]( "FAQs On The Revised EU GMP Annex 1: Volume 7")
FAQs On The Revised EU GMP Annex 1: Volume 7Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.
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![GCAPP_High Class Research Microscope-381_WEST]( "Why Lower Endotoxin Levels Matter: Raising The Bar For Patient Safety And Product Quality")
Why Lower Endotoxin Levels Matter: Raising The Bar For Patient Safety And Product QualityStrengthen patient safety and regulatory compliance with comprehensive endotoxin control strategies designed to support the evolving demands of injectable and advanced pharmaceutical products.
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![GettyImages-949946968-lab-research]( "A Risk-Based Approach To Injectable Combination Product Development")
A Risk-Based Approach To Injectable Combination Product DevelopmentExamine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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![Guidelines For Selecting A Strategic Partner For Your Combination Product]( "Selecting A Strategic Partner For Your Combination Product")
Selecting A Strategic Partner For Your Combination ProductIt is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.
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.
