Combination Products

Prefilled syringes, and prefilled syringes with auto-injectors, continue to dominate the landscape. However, there has been an uptick in the evaluation and use of cartridges in on-body injector systems. The growth of these kinds of products reinforces the need for solutions to deliver larger volumes of biologic products to patients in a simplified manner. The trend from intravenous administration to subcutaneous administration helps to facilitate this patient-friendly option.

There are clear gaps in understanding in the market of combination products. A major one was highlighted at a recent workshop sponsored by West. A survey showed that over 20% of attendees were not aware of the considerations needed to build a control strategy.

Earlier this year, we held a free 3-day virtual workshop (4 hours per day) bringing together industry experts and thought leaders in a unique forum to address a series of challenges and practical strategies to de-risk their injectable combination product development and commercialization.

Do you want to better understand how to navigate the regulatory pathway to successfully bring a drug/device combination product (CP) to market? Understanding that many have this question, West, in collaboration with the Delaware Valley Chapter of PDA, sponsored the symposium (Sep 23): The Evolving Landscape for Combination Products – Defining a Regulatory Strategy. Experts from the industry and the FDA presented and discussed the latest best practices.

The environment for developing an injectable drug device combination product (CP) is dynamic from a regulatory and technical perspective. At the center of it all are the patients and their needs. West is pleased to announce the publication of its review manuscript that provides a detailed overview of best practices for this kind of development program. It considers technical and regulatory aspects and can be used as a foundational document for drug formulators, scientists and engineers working in this area.

Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.