Fran DeGrazio

Chief Scientific Officer

April 07, 2022

Industry Preparedness for Meeting the Challenges of Essential Performance Requirements

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.

EPR On Demand Webinar

At the February 2022 West webinar, Demystifying Essential Performance Requirements (EPRs), several survey questions were posed to attendees to understand both the industry’s knowledge of EPRs, and how prepared they are to meet them. A question regarding what injectable combination products (CPs) are being developed revealed the following trends (Figure 1): 

EPR Figure 1

Now that these innovative CPs are available, the challenge is to meet the needs of the regulators in order to facilitate approval for use in the market. This challenge was the focus of the second question (Figure 2). Key industry concerns include development of an appropriate testing strategy, building the correct data sets, and preparing documentation to support the regulatory filing.

EPR Figure 2

The webinar specifically focused on how to identify EPRs and related control strategies. Having a comprehensive testing plan is critical to regulatory submission. The underpinning of all these activities is a risk-based approach to understand the constituent device and final combination product EPRs. EPRs are defined as: a subset of design controls that relate to assuring that clinical performance of the device itself is adequate to meet the combination product performance intended at the point of dosing.1

The third question revealed that approximately half the attendees did not utilize a risk-based process for identifying EPRs (Figure 3). Not using a risk-based approach increases the potential for failure. Challenges will arise in addressing regulatory questions on subsequent performance testing issues if up-front work is not completed effectively.

EPR Figure 3

EPRs and their associated control strategies are an extremely important piece of the data/documentation that is assembled as part of the CP submission process. The control strategy should provide a complete overview of all points of control relating to the CP and its constituent parts.

More details associated with EPRs and control strategies can be found by viewing this webinar at Unlocking the Mystery of Combination Product Essential Performance Requirements.

 

Reference

1. Diane Harper, Applying ICH Q12 to Combination Products. American Drug Delivery & Formulation Summit. 2019