Newsletter | March 31, 2025

03.31.25 -- Scaling Platform Delivery Of Gene Therapies

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Join experts in drug delivery innovation as they discuss advancements in long-standing devices, systems, and platforms. Covering technologies like autoinjectors, infusion pumps, OBS, combination products, and connected devices, this virtual panel discussion will explore technical and functional innovation needs, challenges, and successes. Register today for Drug Delivery Leader Live happening May 7th!

FEATURED EDITORIAL

Scaling Platform Delivery Of Gene Therapies

By Drug Delivery Leader: Supplier Horizons

Gene therapies aim to treat the root causes of disease rather than merely the symptoms. In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Igor Fisch of NewBiologix, a developer of AAV-based gene therapy platform technologies.

FDA Harmonization Impacts With ISO 13485 On US-Focused Companies

By Mayur Patel, Hilde Viroux, and Emanuel Wasson

FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management compliance.

INDUSTRY INSIGHTS

The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

Article | Battelle

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.

FT-IR Identifies Contaminants And Helps Avoid Hazards, Product Loss

White Paper | By Alan Xu and Chiara De Zorzi, Stevanato Group

Fourier Transform Infrared Spectroscopy (FT-IR) is a reliable method with multiple applications when it comes to identifying both intrinsic and extrinsic compounds in a drug product.

Developing And Manufacturing Minitablets To Extend Drug Lifecycle

Webinar | Catalent

Pharmaceutical companies should leverage oral minitablets to extend drug lifecycles, optimize dosing, and improve patient-centric solutions while overcoming manufacturing challenges.

Formulation Of Crystalline Nanoparticles Enabling Superior Drug Load

Webinar | Nanoform

Explore how bioavailability of poorly soluble APIs can be improved and patient compliance enhanced by reducing the size or number of tablets that a patient must take to achieve the required dose.

Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls

Article | By Jason Miller, Kymanox Corporation

Utilizing off-the-shelf (OTS) devices can offer significant advantages to development programs. Understand the design control responsibilities of a sponsor when using OTS devices.

Simultaneous Spray Drying: Dry Powder Inhaler Combination Formulations

Webinar | Lonza

The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.

SOLUTIONS

Aseptic Manufacturing Services For Filling Various Injectable Formats

Singota Solutions

Small Pack Containment To Ease Early Drug Development

West Pharmaceutical Services, Inc.

Transforming Drug Delivery. Transforming Lives.

Adare Pharma Solutions