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2nd February 2022  Content supplied by: Charles River Microbial Solutions

Rapid Microbial Methods for Short Shelf-Life and ATMP Testing

As short shelf-life therapies and advanced therapy medicinal products (ATMPs), such as cell and gene therapies, continue to grow in importance, so does the need for a test method as advanced as these therapies. This emerging class of advanced products create a new set of challenges for biopharmaceutical companies than those faced by traditional pharma when trying to adhere to CGMP manufacturing methods.  

Challenges of ATMP Rapid Testing

Since ATMPs are typically short shelf-life products, batches must be released at risk and administered to patients ahead of official sterility testing results, when using traditional methods. Small volumes and overall batch sizes limit the amount of total product available for short shelf-life therapy testing. Since living cells exist in an ATMP quality control sample, which may render traditional culture media inherently turbid by nature, this often requires adding sub-culture steps which may extend the test by 14-21+ days.  

Short shelf-life, cell therapy, and gene therapy manufacturing have a specific set of needs based on these challenges:
  • The need for faster results than traditional methods to avoid unnecessary extra days that jeopardize patient safety
  • Objective, confident tests with minimal complexity are needed due to low batch volumes to minimize the risk of human error and need for retesting
  • Non-destructive assays are needed to allow for confirmation and investigations

3 Day Results for Releasing Short Shelf Life Products 

The Celsis Adapt™ Concentrator and Celsis Adapt™ Cell Reagent Kit can overcome the unique challenges needed for cell, gene, and ATMP production and commercialization. Compatible with a wide variety of cellular sample testing from early development to final rapid release results in 3 days, this system ensures patient safety while allowing organizations to deliver critical medicines to patients quickly.

Find out about the features and benefits of Celsis Adapt™ here or contact the supplier for more details using the green "Request Information" button below.

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Date Published: 2nd February 2022

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