Rapid Vaccine Production Requires Rapid Sterility Testing
To answer the need of pharmaceutical and biotech organizations to release vaccines and sterile injections faster, our Microbial Solutions team has developed a complete rapid microbial detection system, including an instrument, reagents/consumables, software, and most importantly, full validation support.
During the COVID-19 pandemic, the need for rapid testing to ensure sterile therapies were safe, effective, and accepted by regulatory authorities was critical and will continue to be moving forward. Every vaccine and injection that is administered to patients is required to be deemed sterile through final product sterility testing.
A clear bottleneck in the production of pharmaceutical products is that traditional sterility test methods require a 14-day sterility test, meaning each lot of vaccines must wait two weeks until they can be released to the public. Combined with additional production wait times incurred by in-process control tests using traditional methods, these life-saving therapies are incurring unnecessary delays and aren’t reaching patients quickly.
In preparation for potential future mass production and global demand similar to what occurred during the pandemic, manufacturers and governments are beginning to seek faster solutions for releasing vaccines and sterile injectables safely to the public.
What is Rapid Sterility Testing?
The Celsis®rapid sterility testing platform consists of instruments, reagents, pre-qualified test consumables, and a unique validation service support package to fast track the time to regulatory approval.
We offer two instruments built on the same technology platform, but with options for high-throughput manufacturing and sample throughput and lower sample throughput.
- Celsis Advance II™ System: Can analyze up to 120 assays/hour; ideal for large-scale production and manufacturing quality control testing
- Celsis Accel® System: Can analyze up to 30 assays/hour; ideal for smaller organizations or supporting process development testing
Amplified ATP-bioluminescence detection reagents allow greater signal generating from the smallest amounts of microbial contamination, and faster, more confident detection than other ATP-bioluminescence methods.
Pre-qualified test consumables from Sartorius (Sterisart® NF canisters) and growth media (TSB and FTM) from Hardy Diagnostics. These consumables are pre-qualified for consistent background ATP levels.
- Hardy Diagnostics Test Media for Celsis® Sterility Applications
- Sterisart® NF System For Celsis® Sterility Applications
Reducing the Burden of Validation
Rapid microbiological method validation takes time (typically 6-20 months) and resources that firms may not have while trying to develop a cure quickly. With this in mind, we offer a comprehensive service package that delivers the regulatory-required validation data from start to finish in less one business quarter.
The Celsis® Complete Validation Support package utilizes the full extent of our portfolio, internal expertise, and capabilities. We have simplified the validation process to provide complete validation data in just 120 days, reducing the burden on organizations seeking to implement a rapid sterility test method.
Quality control laboratories will only need to provide suitable lots of sample product to be validated, perform a technology transfer, and prepare their regulatory submission with the delivered testing data.
The Celsis® Complete Support Bundle Consists of Validation Documentation and cGMP Testing Services
Validation Documentation & Data Package
Celsis® Sterility Equivalency (Membrane Filtration) Report
- A comprehensive 188-page report demonstrating statistical equivalency, limit of detection, and specificity of Celsis® to the traditional method.
Ruggedness Technical Report
Robustness Technical Report
Sterility Sample Effects Testing Protocol
cGMP Testing Services in Presence of Product
Method Suitability Testing in presence of product
- Based on USP <71> Bacteriostasis/Fungistasis (Suitability) testing with additional Celsis® assays to demonstrate the absence of effect by your product.
Equivalency Testing, Limit of Detection Testing, Specificity Testing in presence of product
- Using the same statistical approach and protocol utilized in the Celsis® Sterility Equivalency Report, with the addition of 10 challenge microorganisms (6 compendial, C. acnes, and 3 environmental isolates at 3 titers).
Final testing data will be provided in a customized report format, including key information such as test procedure, results data, statistical analyses employed, acceptance criteria, any deviations (if applicable), and definitive conclusions.