Newsletter | November 24, 2025

11.24.25 -- Practical Application Of Delivery Device Design Controls

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Take a brief tour of Nanoform's advanced nanoformulation, nanoanalytical, and best-in-class capabilities. This video highlights Nanoform’s advanced characterization tools, state-of-the-art formulation technologies, and expert-driven solutions designed to tackle bioavailability challenges. Watch the video now.

FEATURED EDITORIAL

Practical Application Of Delivery Device Design Controls

In this article, Fran DeGrazio provides recommendations for implementing Design Controls in the development of combination products and other drug delivery devices. In outlining tips for drug-device product developers, Fran focuses on key considerations including risk management, chemical and functional compatibility, and regulatory compliance.

Oral Botanicals In The Regulated Therapy Arena

In this episode of Sit and Deliver, host Tom von Gunden talks with Jared Stanley, CEO, and Joel Stanley, board chairman, from DeFloria, a botanical therapeutics development company. Tom talks with the Stanley brothers about cannabinoid-based therapies targeting Autism Spectrum Disorder (ASD). The discussion covers aspects of drug development and delivery including molecule characterization, formulation, and dosing for oral administration, as well as key considerations for commercial-scale production and distribution of regulated botanicals.

INDUSTRY INSIGHTS

Scale-Up And Production Of Key Lipids Used In mRNA Delivery Systems

Discover key strategies for overcoming challenges in the industrial-scale production of ionizable and PEG lipids to optimize mRNA vaccine formulation and address critical manufacturing requirements.

Performance Testing Of Combination Products And Product Packaging

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

Accelerating Drug Development By Addressing Manufacturing Challenges

Expedited development programs require adapting to accelerated development timelines. The challenge is to build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process.

Partnering For Success In Oncolytic Virus Development

Learn how to navigate decision-making at critical steps and find solutions to key challenges in process development and scale-up to expedite oncolytic virus programs.

Particle Size Analysis To Ensure Quality And Performance

Delve into the importance of particle size characterization and the advanced analytical techniques employed to assess micronized particles effectively.

How To Achieve Speed And Success With A Drug Delivery Project

Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.

BD Vystra Disposable Pen

BD Vystra Disposable Pen is a proven, globally adopted drug delivery platform with over 175 million units sold, supporting diverse therapies in 40+ countries.

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Eying The Drug Delivery Regulatory Landscape: The ‘Must See’ Watch List For 2026

Join Chief Editor Tom von Gunden as he engages drug delivery regulatory experts Rumi Young, John “Barr” Weiner, and Fran DeGrazio in a dynamic discussion of the current and near future regulatory landscape for drug and biologics delivery devices, systems, platforms, and combination products. Registration is free, sign up today!

SOLUTIONS

Easy-To-Use 1 mL Disposable Autoinjector

CDMO Selection And Collaboration: Key Criteria And Practices

Inspection Technologies For Particle Quality And Container Closure Integrity