Building an Effective Contamination Control Strategy for Sterile Filtration

The newly revised Annex 1 emphasizes Quality Risk Management (QRM) and highlights how this can inform and direct a contamination control strategy (CCS). The CCS is not a new initiative. The intention of Annex 1 is to use this as a single point of reference that helps define critical control points through data-informed risk assessment, and ultimately to demonstrate a state of process control. But this is not a static state, and the CCS is expected to be a living document, with periodic reviews that drive continuous improvement to further reduce the risk of contamination. 

Sterile filtration plays a critical role in aseptic manufacturing. As innovation in new therapeutic modalities evolve, it is important that end-users understand how to implement a CCS throughout the product lifecycle. Here we outline regulatory expectations for sterile filtration at each stage of product development, and how those feed into the CCS. We also show how shared responsibilities between the end-user and supplier help ensure compliance to Annex 1. Finally, we provide a perspective from a Contract Development and Manufacturing Organization (CDMO) on best practices to ensure compliance with Annex 1.

Presented by Morven McAlister, Global Sr. Director, Regulatory and Validation Consultancy at Cytiva

Morven McAlister is the Global Senior Director of the Regulatory and Validation Consultancy team at Cytiva. She joined Danaher in 2001 and since has held several technical leadership roles in microbial contamination control. Morven has extensive experience with sterile and virus filtration applications, including test design, qualification, regulatory guidance, and process-specific filter validation support. She is also actively involved in various industry task forces to standardize methods and technical positioning around microbial contamination control. She received her PhD in Microbiology from the Queen’s University of Belfast and completed her postdoctoral research at the University of Arizona.

Sponsored by Cytiva

At Cytiva, our mission is to advance and accelerate the development of therapeutics. With nearly 16 000 associates in more than 40 countries, we’re driven to use our expertise and talent to achieve better flexibility, capacity, and efficiency for our customers. Our broad and deep portfolio of tools and technologies, global scale, and best-in-class service provides critical support from discovery to delivery, for customers spanning researchers, emerging biotech, large-scale biopharma, and contract manufacturers. Learn more at cytiva.com.