Symcel: Rapid Sterility Testing for CGT Products
Friday, September 6, 2024 10:30 AM - 10:45 PM
Room R18 – Global Showcase A
Global Showcase Presentation
Presenter
Biocalorimetry, also known as Isothermal Microcalorimetry (IMC), is a growth-based method that provides a direct and continuous measurement of released heat, a measure of the metabolic rate of living cells.
This is a game-changer for detecting living microorganisms, especially in rapid microbial sterility testing for product release and in-process testing. The calScreener+ detects even the smallest amounts of metabolic heat from living microorganisms. With this high sensitivity, it objectively detects contaminations originating from a single cell (LOD 1) even in small-volume samples. This makes it a reliable tool that meets the standards for the release of short shelf-life products as outlined in USP <1071>. (USP〈1071〉, 2024)
Biocalorimetry with the calScreener+ stands out because it measures continuously and in real-time, catching any contaminant as it hits the detection threshold of replicating cells, in most cases before the total test window closes. Matched with the rapid detection of pathogenic organisms, this capability can make it possible to implement intermediate release or conditional release within just one day. It also supports early intervention and contamination source mitigation and helps to reduce vein-to-vein time for patients awaiting cell and gene therapy (C>) treatments. Additionally, an automated readout reduces manual labor, bias and simplifies the process of the release test.
ICM is also non-disruptive. In the event of contamination, direct downstream investigation for species identification, etc. can be started immediately. This makes the calScreener+ particularly promising for ensuring product safety and timely delivery in cases like cell & gene therapy with short shelf lives and expensive individualized material.
Session Objectives:
We will take a deep dive into biocalorimetry and how Symcels solution enables detection of living microorganisms in under 3 days. This is direct on product, in a non-destructive continuous phenotypic measurement enabling recovery and ID of contaminants. We will discuss the technology, internal validation progress, and specific data including for slow growers and inhibitory matrices.
- Marta Veses Garcia, PhD, Head of Assay Development, Symcel, Sweden
Biocalorimetry, also known as Isothermal Microcalorimetry (IMC), is a growth-based method that provides a direct and continuous measurement of released heat, a measure of the metabolic rate of living cells.
This is a game-changer for detecting living microorganisms, especially in rapid microbial sterility testing for product release and in-process testing. The calScreener+ detects even the smallest amounts of metabolic heat from living microorganisms. With this high sensitivity, it objectively detects contaminations originating from a single cell (LOD 1) even in small-volume samples. This makes it a reliable tool that meets the standards for the release of short shelf-life products as outlined in USP <1071>. (USP〈1071〉, 2024)
Biocalorimetry with the calScreener+ stands out because it measures continuously and in real-time, catching any contaminant as it hits the detection threshold of replicating cells, in most cases before the total test window closes. Matched with the rapid detection of pathogenic organisms, this capability can make it possible to implement intermediate release or conditional release within just one day. It also supports early intervention and contamination source mitigation and helps to reduce vein-to-vein time for patients awaiting cell and gene therapy (C>) treatments. Additionally, an automated readout reduces manual labor, bias and simplifies the process of the release test.
ICM is also non-disruptive. In the event of contamination, direct downstream investigation for species identification, etc. can be started immediately. This makes the calScreener+ particularly promising for ensuring product safety and timely delivery in cases like cell & gene therapy with short shelf lives and expensive individualized material.
Session Objectives:
We will take a deep dive into biocalorimetry and how Symcels solution enables detection of living microorganisms in under 3 days. This is direct on product, in a non-destructive continuous phenotypic measurement enabling recovery and ID of contaminants. We will discuss the technology, internal validation progress, and specific data including for slow growers and inhibitory matrices.
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