Promitec 10 Delivers...
28th January 2022 Content supplied by: Promicol B.V.
Promicol PRENOVA® Platform – Rapid QC for Vaccine and Cell and Gene Therapy Products
The safety of vaccines and cell and gene therapy products is paramount to ensure their safety and effectiveness. Once the product is manufactured, it is ready for quality control testing which is crucial to confirm that the final product can be administered to patients in a safe and reliable form.
As the quality control of vaccines is still mainly regulated by compendial methods it can take 14 days and more before a batch can be released to be administered to all the people worldwide waiting to be better protected. Promicol has developed a method for rapid and reliable QC of vaccine preparations shortening the time to release to 72 hours with Promicol PRENOVA® COV1. Our ATP-Bioluminescence-based technology is not only applicable to COVID-19 vaccine preparations but can be applied to the quality control procedures for all kinds of vaccines.
Similarly, Promicol offers through PRENOVA® TCT3 a rapid method for quality control of cell- and gene therapy products like e.g., CAR-T products. Also, for these kinds of products, the testing time can be shortened to 72 hours using the Promicol PRENOVA® technology platform compared to 9 – 14 days using compendial or other modern semi-rapid technologies. This dramatic shortage of QC time can be lifesaving for patients fighting cancer or other life-threatening diseases.
At Promicol everything required for this novel and fast QC method is provided from one source: instrument, reagents, ATP-free components/consumables, software, and support.
The Promicol Novilite instrument is a compact luminometer specially designed for application of the PRENOVA® platform technology. Promicol reagents are supplied in an easy-to-use format and customizable test kits based on your throughput. Promicol PRENOVA® technologies use special enrichment broths that are supplied as part of the test kit and can be used either for direct inoculation or in combination with filtration – suiting the individual needs and requirements of our customers. The Promicol proprietary software allows fully automated testing both for PRENOVA® COV1 as well as PRENOVA® TCT3 applications. And in case of any questions, you can reach us 24/7 for immediate help and support.
With a just-in-time mindset, Promicol has always helped and assisted numerous (contract) manufacturers to decrease time in the manufacturing process for quality assurances. We have seen (contract) manufacturers adopting speed and rapid-ness as Project Lightspeed and Project Warp speed. With our PRENOVA® assay, we will bring your project in Lightspeed mode.
Promicol ensures that our customers are satisfied and that we can offer them possibilities to increase their efficiencies and improve their quality control procedures, always.
It is our goal to provide a service that is in touch with the needs of your quality management and to your demands from rapidly changing markets, making ATP work for you, together with you. If you want to discuss the best strategy for your company, just get in touch and we are convinced to offer a suitable solution to you.
Visit Promicol or click on the Request Information button below.
Date Published: 28th January 2022
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