In this article, Chief Editor Tom von Gunden considers the expanding range of addressable targets for inhalation drug and biologics delivery. He reports on innovations in oral and nasal inhalation technology that enhance approaches to traditional respiratory indications, as well enable delivery of inhaled therapies to systemic targets beyond the nose and lungs.
- Why Operational Readiness Is The Missing Piece In Biosimilar Adoption
- From Vial To Prefilled Syringe: Mastering The Development Transition
- Rethinking The Blueprint For Bone Regeneration: The Next Evolution In Orthobiologics
- Can We Cure Diabetes?
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?
- Red Blood Cell-Based Delivery: Promising Steps Forward
- Stability And Release Testing For Delivery Devices: Waived Or Wanted?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Masking Bitter Drug Taste In Pediatric Formulations With Microcaps
The challenge was developing a taste masked, convenient dosage formulation of a very bitter API for patients two-years old and older undergoing treatment of HIV infection.
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Extending The Reach Of Critical Care: Remote Sensing
In emergencies, scarce data delays decisions. Remote sensing — radar, thermal, and vision — assesses patients at a distance, enabling faster triage, smarter resource use, and more informed care.
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Evaluation And Identification Of Subvisible Particulate Matter In Injections
Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.
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Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System
Whether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.
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Enabling Subcutaneous Delivery For Improved Patient Compliance
The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens.
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FAQs On The Revised EU GMP Annex 1: Volume 8
Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.
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The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine
The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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4 Factors Affecting Solubility Of Drugs
Improper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.
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The Role Of Micronization In The Journey To Drug Product Development
Micronization is an incredibly important step of the process of transitioning a compound from initial discovery into the clinic. Learn more about the key benefits of micronization.
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Opioid Reformulation Filed As A CMC Supplement In Less Than A Year
Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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From Vial To Prefilled Syringe: Mastering The Development Transition
In this article, Fran DeGrazio discusses the opportunities, challenges, and benefits for biopharmaceutical product developers in transitioning from vial-based to prefilled syringe (PFS) delivery approaches. She lays out key differences and added complexities in areas such as device functionality, risk management, regulatory pathways, use of materials, lifecycle management, and organizational alignment.

