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- Unpacking The FDA Draft Guidance On Container Closure Systems
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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How A Flexible Approach To Autoinjector Assembly Can Be Advantageous
Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.
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Utilizing Robotic Aseptic Filling Systems To Meet Industry Needs
An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
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Key Considerations For Selecting Flexible Fillers
Flexible 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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Effects Of Annex 1 Revisions On Manufacturing Operations
The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.
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How Subcutaneous Delivery Can Help Patients Manage Chronic Conditions
Read more about how to improve your patients’ outcomes, avoid costly delays to launch, and provide a better return on investment.
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3D Printing Of Pharmaceutical Dosage Forms – Has The Time Come?
Additive manufacturing, or 3D printing, is arguably balancing on the cusp of translation from academic research into industry practice for pharmaceuticals. What will the future impact of 3D printing be?
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5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes
In our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.
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Considerations In Formulation Development Of Injectable Solutions
Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.
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New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology
Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.
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Advancing Biopsy Device Performance Through Precision Overmolding And Assembly
Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Unpacking The FDA Draft Guidance On Container Closure Systems
In 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.

