Accelerate Cell and Gene Therapy Sterility Testing with Celsis®
Celsis® rapid microbial detection systems including the Celsis Adapt™ accessory are purpose-built for complex cell-based and gene therapy matrices. These technologies support advanced manufacturing environments by delivering:
- Rapid time-to-results: Sterility test results in as little as 4 days, a significant improvement over the 14-day compendial method
- Broad compatibility with cell lines: Including HEK293, CHO, T-Cells, and more
- Objective result interpretation: Eliminate the variability of manual readings
- Automated result documentation: Seamlessly integrates with your digital QC and LIMS workflows, removing analyst documentation errors
- Regulatory alignment with USP <73>, <1071>, <1223>, and European Pharmacopeia 5.1.6
By replacing lengthy incubation-based sterility tests, CGT manufacturers and CDMOs can reduce product hold times, de-risk release decisions, and meet patient demand faster, without sacrificing confidence in test outcomes.
Regulatory Changes: USP 73 & 1071 Updates at a Glance
Rapid sterility testing for cell and gene therapy demands strict regulatory scrutiny. Celsis systems and our expert support help you prepare for audits and global submissions with USP-aligned technical documentation and supportive resources that map directly to evolving global standards
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Cell Therapy Sterility Testing Case Study
Advanced medicinal therapies, often derived from mammalian- or human-cellular tissues or cell lines, present unique interferences with bioanalytical assays. Labors LS and Charles River share a detailed account of implementing ATP-bioluminescence for rapid microbial detection in complex, cell-based matrices.
Labor LS, one of Europe’s largest independent pharmaceutical contract laboratories, has relied on the Celsis® system since 2008. Its high level of alignment with the compendial method makes it very easy for employees to use and significantly increases authority acceptance. The Celsis Adapt™ System, which represents the latest development of the Celsis® platform for cell-based samples, has also proven itself in practice and provides indispensable services in microbial testing of cell-based preparations.”
Stefan Gärtner, Head of Department, Test for Sterility, Labor LS
Discover how other innovators are achieving success
- In this on-demand webinar, Labor LS showcases how ATP-bioluminescence was validated in alignment with Ph. Eur. 5.1.6 and USP <1223> for advanced biological matrices.
Watch now - Explore how ATP-bioluminescence helps overcome validation challenges in cell-based products.
Access the article - In this on-demand webinar, Merck scientists present a case study on how they successfully applied an existing method for the detection of microbial contaminants to optimize their qualification of cell lines and viral stocks used in biology QC studies, such as viral clearance, viral safety, and in vitro potency.
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Demystifying QC testing challenges in cell and gene therapy manufacturing
Whether manufacturing ATMPs in-house or outsourcing to a CDMO, understanding quality control points is vital to prevent contamination and protect your product. Testing for bacterial endotoxins, microbiological contamination, and identification is crucial during commercialization and also benefits early RUO samples.
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Benefits of Celsis® for Cell and Gene Therapy Sterility Testing
- Rapid, reliable sterility results in complex biological systems
- Scalable solutions for clinical and commercial batch volumes
- Full compatibility with autologous, allogeneic, and viral vector-based workflows
- Proven use across global CGT manufacturing and CDMO networks
Explore the Celsis® Rapid Microbial Detection Brochure
Gain insight into Celsis® technologies, platform capabilities, implementation considerations, validation support, and microbial detection applications across a range of product types.
Access the Brochure
Ready to reduce timelines for cell and gene therapy sterility testing?
Connect with our experts to discuss how Celsis and Celsis Adapt can support your cell and gene therapy workflows, from validation to full-scale deployment.
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Frequently Asked Questions About Rapid Sterility Testing for Cell and Gene Therapies
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How does cell and gene therapy sterility testing work?
The sterility testing methods outlined in USP <71> and Ph. Eur. 2.6.1 include membrane filtration and direct inoculation. The product can be filtered through a membrane, and the membrane transferred to a media container (or the membrane is included in a container that is filled with media). The media is incubated for 14 days. After incubation, the media is removed and visually checked to identify turbidity, which is a sign of microbial contamination.
Many cell and gene products are not filterable with a filter pore size that can adequately differentiate between microbes and the product. For these products, the direct inoculation method is preferred, where the product is directly placed into a media container. The incubation and inspection process aligns with the membrane filtration method.
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What methods are used?
Sterility testing for cell and gene therapies is performed the same way as any other product, most commonly through the 14-day traditional sterility method outlined in USP Chapter <71> and European Pharmacopoeia (Ph. Eur.) 2.6.1.
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Are alternative test methods acceptable?
Yes. The USP chapter <1223> and European Pharmacopoeia chapter 5.1.6 outline ways to validate alternative methods to ensure the method performance is not inferior to the traditional methods. USP Chapter <1071> outlines alternative technologies, like ATP-bioluminescence, that can be used to validate a method for a risk-based release approach. USP Chapter <73> outlines how the principles from Chapter <1071> can be applied to validate ATP-bioluminescence as an alternative method.
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What are some related resources for cell and gene therapy sterility testing?
- A Rapid Microbiological Method Case Study for Advanced Therapy Medicinal Products - Stacy Ramsey, Senior Manager, Celsis® & Microbial Applications Lab
- Optimizing Contamination Control in Cell & Gene Therapy - Brice Chasey, Associate Director, Product Management, Celsis®
- Enhancing Rapid Microbiology QC in Cell & Gene Therapy - Jeff Domsic, Sr. Scientific Portfolio Specialist, Microbial Solutions