Alternatives to Testing Sterility in Cell- and Tissue-Based Products
Manufacturers of cell- and tissue-based products are constantly striving to find the right balance between assuring sterility and ensuring cell- and tissue-based products retain their respective viability and functionality. Alternative testing methods are emerging as the demand for the faster release of these products continues to rise. Regulatory agencies are increasingly supportive of alternative methods, so long as they are backed by robust validation data.
Anthony Thatcher and Prethib Arumugam, both with Sumitomo Pharma America, recently held a presentation on this topic at the 2025 ISPE Aseptic Conference. In the article that follows, they summarize key points from the presentation—explaining why sterility for cell- and tissue-based products is especially challenging, describing alternative testing methods, discussing evolving regulatory perspectives, and outlining key considerations for how to balance the need for sterility assurance without compromising cell viability and function.
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Cell & Gene delivers in-depth content about cell and gene therapies from experienced professionals in the field. This publication focuses exclusively on this segment of the life sciences industry.