Over the last two years RIBOPRO has slowly but surely build up a reputation with the production of high-quality messenger RNA (mRNA) products. The fast delivery, complete service and in-depth knowledge results in satisfied customers. Even more important, it also ensures that the customers of RIBOPRO are able to develop the mRNA-based medicines at high speed, which is fully in line with the company’s mission. These developments are going with such a speed that the first customers are now entering the clinical phase, and in order to meet the associated requirements for Good Manufacturing Practice (GMP) quality material, RIBOPRO is launching the first Netherlands-based GMP factory for mRNA.
The GMP production location is set up in Maastricht in collaboration with Medace, another Dutch biotech company. At that location, Medace operates a facility with several cleanrooms of various grades (A, B and C), which are suitable for a wide range of biomedical activities, such as the production of medicines under GMP conditions. As an extra service, Medace provides personnel support (especially Quality Assurance), management of the common areas, and very importantly, knowledge and expertise in setting up a Quality Management System. Yvette Zimmerman, COO at RIBOPRO:
“As a start-up with an academic origin, RIBOPRO has a lot of knowledge and expertise of mRNA and its production, but producing it under GMP conditions requires additional expertise. There is a lot involved, such as setting up a Quality Management System with associated SOPs (Standard Operating Procedures), Work Instructions and other quality documents. In addition, the production process must be adapted and validated to comply with the GMP requirements. In this regard, it is very helpful to work with a party that has already done this several times and has knowledge of the latest guidelines. Medace is such a party, and together we have set up a state-of-the-art GMP process in a short period of time.”Yvette ZimmermanRIBOPRO COO
The fact that the factory is equipped with the latest techniques fits the innovative character of RIBOPRO. With in-house developed and built equipment and with high-quality research, the company has improved processes and developed various new technologies. The importance of this is underlined by Sander van Asbeck, the co-founder and CEO of RIBOPRO:
“mRNA is a relatively new technology, which has recently proven itself in the context of (corona) vaccination. However, mRNA has many more applications that are now being investigated by hundreds of our customers. What has become clear is that for therapeutic use, even more than for vaccination, the quality and purity of the mRNA is of great importance. The systems available to date rely on extensive, but inefficient and cost-increasing purification. Through innovations in the enzymes for IVT (in vitro transcription - the process of making mRNA), the process conditions and the post-processing, RIBOPRO strives to become a world leader in the manufacturing of high-quality mRNA.”Sander van AsbeckRIBOPRO co-founder and CEO
The new GMP factory, using single-use consumables and a fully closed system, will open at the beginning of the new year 2023 and is suitable to produce milligrams up to 100 grams of mRNA per batch.
“That doesn't sound like much, but 100 grams is enough to vaccinate 1 million people. More importantly; by also offering smaller quantities of GMP grade mRNA material to our customers, we make the transition from research to clinic easier and less expensive, which ensures that medicines reach the patient faster, and that is what really matters to us. We should not forget that there are also many applications where smaller quantities are required, such as personalized medicine”Walter van der HeijdenRIBOPRO GMP-manager