Newsletter | February 3, 2025

02.03.25 -- Understanding CGMPs For Combination Products

SPONSOR

Registration for INTERPHEX 2025 is officially live! Happening April 1-3 in NYC, INTERPHEX is the largest pharmaceutical and biotechnology event of the year. Join over 9,000 industry professionals and 500+ exhibitors from all over the world as we take you through the entire pharmaceutical product development lifecycle. Follow the link to claim your FREE Exhibit Hall badge.

FEATURED EDITORIAL

Understanding CGMPs For Combination Products

Watch as editor of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems Susan Neadle and chapter four co-author Mike Wallenstein share their perspectives on combination product CGMP’s, including regulatory definitions and differences in the U.S. and Europe, supplier controls, design controls, and manufacturer responsibilities.

INDUSTRY INSIGHTS

Customized Release Through Dispersed Dosage Formats

Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.

Nanomedicine: New Possibilities For Treating Rare Genetic Diseases

Gene therapy offers hope for rare genetic diseases, with advancements in polymer nanoparticles addressing delivery challenges and paving the way for innovative, effective treatments.

Patient-Centric Drug Design, Dosing, And Delivery

Experts discuss the best time to start thinking about patient-centricity, the steps developers can take to achieve patient-centric drug design, and how formulation and dosage forms can make a difference.

Vial Containment Systems Based On Elastomer 4031/45 Gray

For a properly-assembled vial containment system, good container closure integrity performance can be achieved with stoppers of a given elastomer, independent of configuration.

Expanding Home-Based Care With A Next-Gen On-Body Delivery System

As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.

Nose To Brain (N2B) Drug Delivery – Benefits And Challenges

Delve into the growing interest in drug delivery methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).

Engineering Approaches To Respiratory Drug Delivery

Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

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Join us for an engaging Drug Delivery Leader Live. Explore FDA guidance on Essential Drug Delivery Outputs (EDDOs) with practical tips and expert insights. This interactive session covers implementation strategies and key recommendations for optimizing delivery outputs in product design, development, and regulatory planning for combination products and delivery systems. Don’t miss this opportunity to enhance your understanding and refine your approach. Register today!

SOLUTIONS

Solvent-Free, Fusion-Based Amorphic Dispersion Process

Pharmaceutical Dosage Form Development

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