Newsletter | July 19, 2023

07.19.23 -- Industrializing Drug Delivery - Insights To DeRisk The Transition To Combination Products

Development Of An Injectable Combination Product: A Risk-Based Approach

Drug-device combination products (DDCPs) leverage new technologies that provide advantages for patients, such as self-administration conveniences and safety, and, for payers, improved adherence. Examine how to establish a holistic approach to DDCP development and how to assess and manage risk throughout the development and approval process.

USP <382>: Think Systems, Not Components

United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

The Dynamic Regulatory Environment Of Drug-Device Combination Products

A drug-device combination product, such as a prefilled syringe or autoinjector, will have different drug and device requirements. This white paper examines the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time to market.

Key Considerations For Selecting Flexible Fillers

With the ability to launch in vial configurations, prefilled syringes, or other combination products including devices, flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

Successful Industrialization Requires Solid Foundations

Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges — most notably extractables, leachables, and particulates — which are some of the primary reasons for a product recall.

Benefits Of QbD For Drug-Device Combination Products And Partnerships

Quality by Design (QbD) achieves quality through understanding of all components and processes, with a detailed understanding of risks and how they can be mitigated. Consider QbD for elastomer components — in particular NovaPure® plungers for prefilled syringes.


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