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
-
Partnering With Clinicians To Improve Pediatric Formulation Development
Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
-
Addressing Glass Particulates In Injectable Drug Formulations
Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.
-
Lyophilized Products Are On The Rise: What You Need To Know
There is increased demand for lyophilization services in the manufacturing of new biologic drugs and injectable formulations as well as in change of formulation presentation.
-
Semi-Solid And Semi-Liquid Dosage Forms: What To Know
Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider.
-
Mechanical Engineering Design Process For Combination Products
Mechanical engineering for combination drug-delivery devices demands more than good design — it requires data-driven risk management from specs through simulation. Learn how a structured phase approach ensures global manufacturing readiness.
-
Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges
An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.
-
New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway
Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
-
Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing
This 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.
-
Self-Injection Of Biologics Made Easy
Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.
-
How To Leverage Modeling And Simulation In The Candidate Development Stage
Modeling 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.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
-
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.

