mRNA-Based Therapeutics Demand Faster, Smarter Testing
Unlike traditional therapies with long, costly cycles, mRNA-based therapeutics demand agile, efficient processes from discovery to release. These therapeutics changed the game, speeding development, slashing timelines, and leading the charge during the COVID-19 pandemic. But while biotech firms raced toward approval, many overlooked a critical barrier: outdated microbial testing. To truly deliver fast, safe therapies, quality control must keep pace. That’s where rapid methods like Celsis make the difference.
mRNA: The Molecule Behind Modern Medicine
mRNA, a molecule used by all living organisms to build proteins, is now powering a new generation of biologics. Biotech innovators are harnessing its natural role to develop targeted therapies for cancer, infectious diseases like COVID-19 and influenza, and rare genetic conditions, transforming how medicine is made and delivered.
As of November 2025, Charles River market research analysts determined there are approximately 160 mRNA therapeutic candidates in development, with 58 in phase I clinical trials and 76 in phase II.
Of these candidates, the front-runners in the field are Moderna Therapeutics (44 candidates), WestGene Biopharma (17 candidates), BioNTech (16), CureVAC (16), and Sanofi (16 candidates).
Outdated Testing Is Slowing Your mRNA Breakthroughs
Many labs are using machine-learning algorithms to accelerate discovery; yet ironically, many still rely on slow, manual microbial testing, which delays product release. Waiting 14 days for subjective sterility results slows your ability to respond and release. Even bioburden testing adds unnecessary delays, often yielding zero counts after days of incubation. For mRNA therapeutics, every day matters. Faster testing means faster decisions and faster delivery.
Our rapid testing solutions replace subjective, time-consuming assays with fast, automated results, helping you meet global standards and get to market faster.
Accelerate Validation Without Compromising Standards
Celsis helps vaccine manufacturers release safe, high-quality therapies faster:
- Leverage your current traditional preparation method for final sterility
- Reduce the incubation period by 8 days (14 days down to 6)
- Gain clear, objective contamination results with automated detection
Our method equivalency report, demonstrates equivalency of the Celsis method to the traditional membrane filtration method, according to USP <71>, <73>, and USP <1223>. Our application laboratories can repeat this testing for your intended use to significantly reduce the time needing to onboard and implement this new method. This validation approach has been successfully reviewed by regulators around the globe.
Get faster implementation via two new validation support packages to demonstrate method equivalency, microbial limit test method validation, specificity, ruggedness, robustness, and method suitability of the Celsis rapid microbial detection method.
Accelerating mRNA Therapeutics with Celsis®
Southern RNA, a leading Australian CDMO, validated a 24-hour bioburden test with Celsis to accelerate product release. They met TGA and global regulatory standards, improved operational efficiency, and are now positioned to expand rapid microbial detection across Australia’s biotech sector.
See how they did it
Compatibility Means Cost Savings
Celsis instruments and reagents have industry-leading compatibility with other sample types and test methods. This system is compatible with:
- Filterable and non-filterable samples
- High or low pH products
- Products containing high debris or fluorescent particulates
- Biologic products including nucleotides, proteins, and vaccines.
This, in turn, allows the technology to be applied to traditional assays upstream in the development chain. Companies can test column chromatography matrix samples, cell culture growth media, and sterile water for injection using Celsis. The net result of saving multiple days of incubation along many development and quality test assays has a cumulative effect for both speed to approval and speed to market- because every moment matters.
Interested in learning more? Speak with an expert.
References
- mRNA Vaccines and Therapeutics Market Forecast 2019-2029
https://visiongain.com/report/mrna-vaccines-and-therapeutics-market-forecast-2019-2029/ - Citeline (Source: Pharmaprojects March, 2020)
- mRNA Will Revolutionise the Biopharmaceutical Industry, Dr. Ingmar Hoerr
https://www.ddw-online.com/mrna-will-revolutionise-the-biopharmaceutical-industry-1380-201510/ - Can mRNA disrupt the drug industry?
https://cen.acs.org/business/start-ups/mRNA-disrupt-drug-industry/96/i35