Rapid Cell Culture Contamination Detection
The Celsis Adapt™ cell application was designed for cell-containing samples, such as in-process quality control samples from cell culture manufacturing and rapid sterility testing of cell-based therapies. The Celsis Adapt™ provides a reduced time-to-result of less than seven days versus the 14 days needed for the longer compendial test.
Reducing the Time to Result for Cell Culture QC Samples
There are many steps during the standard biomanufacturing process requiring quality control (QC) sample testing, from upstream processing steps in cell culture through fermentation, to downstream purification and fill/finish. Many upstream in-process control samples contain cells, which require additional sub-culturing steps when using traditional growth-based tests on top of the 14-day sterility test commonly employed. These lengthy incubation periods impose unnecessary operational challenges to manufacturing while production continues at risk.
Overcoming the Challenges
When a contamination event occurs, not only is overall batch yield and productivity impacted, but additional loss of time, money, and materials used to remediate the contamination are incurred if not detected as soon as possible. These unforeseen costs can be reduced greatly when rapid microbiological methods are implemented that can detect cell culture contaminations. Unfortunately, due to the presence of cells, quality control microbiology labs have encountered challenges implementing growth based rapid microbial methods due to background interference.
Results in Seven Days for Samples Containing Cells
The Celsis Adapt™ system removes production cells and debris, leaving only potential bacterial, fungal, and mold contaminants behind, allowing for rapid analysis on Celsis® luminometers. Results can be obtained in only 7 days for cell-containing samples, reducing the time-to-result by more than 50% in many cases. When considering the additional applications for Celsis ATP bioluminescence, including rapid sterility testing for product release in 6 days, companies can now utilize a single rapid microbiological method for the entire pharmaceutical production process.
Our Rapid Microbial Detection Systems for Cell-Based Samples
The Celsis Adapt™ is an accessory instrument for Celsis®rapid detection systems, intended to prepare and concentrate samples containing components that interfere with the background and ATP-bioluminescence detection signal, expanding the application portfolio for Celsis® luminometers.
Charles River recommends combining Celsis Adapt™ sample concentrator with the Celsis Advance II™ luminometer for rapid testing of cell culture samples and cell-containing quality control samples. Capable of running 120 assays per hour, this instrument is best suited for high throughput pharmaceutical bioprocessing.
The Celsis Adapt™ sample concentrator is also compatible the smaller Celsis Accel® luminometer. With a throughput rate of 30 assays per hour, this instrument is a smart option for contamination control for small to midsize biopharma manufacturers, or for optimizing quality testing during research, commercialization and cell culture process development.
Celsis Adapt™ Product Details
Size (Height x Width x Depth): 13 in x 11 in x 7 in/33 cm x 27.9 cm x 17.8 cm Weight: 8 lbs/3.6 kg Electrical Requirements: Supply: 100-240 VAC, 50/60 Hz, 1.5 A
Operating: 12VAC – 5A, 60W
Maximum Sample Volume: 10 mL Software Compatibility: Operated with on-board firmware
Celsis® Instrument Compatibility:
Celsis Advance II™
Celsis® Reagent Kits Available: Celsis Adapt™ Cell 100 Kit
Product Description Product Code
Celsis Adapt™ Sample Concentrator
Celsis Adapt™ Instrument
Power supply with Type B, C, and G regional adapters
Washing solution adapter
Tubing line and clip
Celsis Adapt™ Cell 100 Kit
Celsis Adapt™ Cell Reagents
Celsis Adapt™ Concentrating Solution, Sterile x 3 cans
Celsis Adapt™ Tips, 0.2µm, Sterile x 40 tips
Celsis Adapt™ Maintenance Tip x 1 tip
Celsis Advance II™ Instrument
Celsis® Advance II.im Software
The Celsis Adapt™ method does not impact the specificity of the overall Celsis® ATP-bioluminescence. As part of a rigorous development and method validation program followed by beta testing in collaboration with several pharmaceutical companies, the Celsis Adapt™ has been proven to detect the presence of the following common challenge microorganisms, but not limited to those as stated in regulatory guidance documents.
Compendial challenge organisms
Industry-relevant and objectionable organisms* Aspergillus brasiliensis Burkholderia cepacia Bacillus subtilis Clostridium sporogenes Candida albicans Cutibacterium acnes Escherichia coli Kocuria rhizophila Pseudomonas aeruginosa Penicillium chrysogenum Staphylococcus aureus
*A longer list of industry-relevant and objectionable organisms can be found in the Celsis Adapt™ Sample Concentrator product sheet.
Cell Line Compatibility
In order to provide a complete solution for in biopharma processing and cell-based production, the Celsis Adapt™ Cell Testing system was rigorously tested for specificity and method suitability for a growing list of commonly used cell lines, such as:
- CEF (chicken embryo fibroblast)
- Mesenchymal Stromal cells
- CHO-K1 (Cricetulus griseus, Chinese Hamster ovary)
- CHO-BHK21 (Baby Hamster kidney cell)
- HEK-293 (Human embryonic kidney)
- HeLa (Human)
Limit of Detection
The limit of detection for the assay remains at 1 CFU and continues to adhere to validation parameters described in PDA TR 33, USP <1223>, and Ph. Eur. 5.1.6. This sample preparation still maintains the non-destructive benefit of Celsis® ATP-bioluminescence, while utilizing a small amount of the original incubated sample.
Frequently Asked Questions about Rapid Microbiological Method Applications for Cell Culture Samples
How do you test for contamination in cell culture?
Cell culture samples are typically tested as in-process controls samples, using bioburden or microbial limits test parameters, relying on incubation times of 3-7 days using membrane filtration. Cell containing test samples commonly contain in-process cells, such as mammalian or CHO cells.
Rapid microbiological methods can be used here, but bioprocessing cells must be differentiated from microbial contamination cells using a lysis process or by mechanical removal.
What are cell culture in-process control samples?
Cell culture in-process control samples are quality control microbiology samples taken during the cell culture or fermentation bioprocessing step to detect the presence of contamination in samples containing the therapeutic-generating host cells.
What should I do if there a is cell culture contamination?
If in-process testing reveals a contamination, an investigation should be performed if the results exceed your established alert/action limits. Typically, investigations involve retesting and/or a remediation, such as cleaning.
What is rapid cell culture contamination testing?
By using a rapid microbiological method for cell culture or cell-based samples, detection can occur days faster than the traditional test method, reducing overall production cost if the batch must be scrapped, and cleaning additional downstream equipment if production continued at risk. Moreover, when performing a follow-up investigation, a non-destructive rapid method, like Celsis Adapt™, allows for a retest or microbial identification through our Accugenix® microbial identification and strain typing services.