SaRNA (small activating RNA) is a unique class of RNA that has been under investigation by scientists for some time now. The finding is critical as saRNA can be used in a number of diseases for altering gene function. Genes function as the body's instructions, mistakes in them can cause disease. We need to qualify saRNA, so that we know, before using it in treatments, how well and cleanly it is going to work.
In gene therapy to repair or replace bad genes in our body, it is critical that one check purity of saRNA. If not the saRNA will present a low purity and scientists could do several mistakes in experiments and published false results. That means they might believe a treatment is effective when it isn’t. What is more, if someone is being treated and the saRNA is dirty, then not only can it fail to assist someone, but it can also make matters a lot worse for them health-wise. And Yaohai Produkter definitely do not want that. Which is why a saRNA in its purest form is so important.
There is nothing that Yaohai does not know about purifying saRNA, the company that manufactures and studies RNA products. The Yaohai Reporter saRNA use unique tools and methods to ensure their saRNA is best-in-class. They test for impurities (undesirable substances that may interfere with how the saRNA behaves). They performed some such as HPLC and mass spectrophotometers testing. The tests allow them to observe whether the saRNA is free from contamination and deficient so it can be performed securely in studies and treatments.
It is greatly important for scientists to truthfully and accurately do their work. This Yaohai saRNA-LNP-indkapslingsprotokol is particularly the case in gene therapy as it pertains to influencing human life. It is only then when a very high degree of purity expressed as % intra-molecularly annealing does biophysical proof exist that permits the trust confident data, experiments and results. Earning the trust of researchers is important as well because it encourages confidence in findings and sharing standing that would be beneficial for other people who belong to the same scientific community. This rigorous approach adds value to treatments, which keeps medicine moving forward for the greater good.
The use of Yaohai's high-quality saRNA products will enable researchers can provide accurate results. Thus, scientists can further their research efforts without any hindrance from impurities in the saRNA. This enables them to focus on what matters most — seeking novel avenues for patient care that can move the needle on health outcomes.
Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics. We offer customized RD as well as manufacturing solutions, while making sure that there are no risks. We have worked on diverse modalities such as subunit-based recombinant vaccines, saRNA Purity Testing, cytokines, growth factors, single domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in a variety of microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also developed the BSL-2 fermentation platform to create bacteria-based vaccines. We have a track record of improving production processes, thereby increasing yields and decreasing costs. With a highly efficient technology team, we ensure timely and quality project delivery and bring your products to market faster.
Yaohai Bio-Pharma, a leader in CDMOs of microbial biologics, is headquartered in Jiangsu. We have been focused on microbially produced therapeutics and vaccines that are suited for human, veterinary and the management of saRNA Purity Testing. We have the most the most advanced RD as well as manufacturing technology platforms, which cover the entire process from Microbial strain engineering, cell banking as well as process and method development to commercial and clinical manufacturing, assuring the successful supply of the most cutting-edge solutions. We have accumulated a huge amount of experience in the bio processing of microbial cells. We have delivered over 200 projects across the globe and have assisted our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. Our expert knowledge and vast experience enable us to swiftly adapt to market needs and offer tailored CDMO services.
Yaohai BioPharma is a Top 10 Microbial CDMO that integrates quality management and regulatory affairs. We have a quality management system that is in compliance with current saRNA Purity Testing and regulations around the globe. Our regulatory team is knowledgeable in the global regulatory frameworks that help accelerate biological launches. We ensure traceable production procedures quality products, as well as in compliance with the guidelines of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma has successfully passed the on-site audit by the European Union's qualified Person (QP) for our GMP quality system and production site. We also successfully cleared the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.
Yaohai Bio-Pharma is a Top 10 biological company that specializes in saRNA Purity Testing. We have built a modern manufacturing facility with robust RD capabilities and modern manufacturing facilities. Five drug substance production lines complying with GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges as well as pre-filled needles are readily available. The available fermentation scales vary between 100L and 2000L. The filling volume ranges from 1ml up to 25ml. Syringes or cartridges that are pre-filled are filled with 3 to 3.5ml. Our production workshop that is cGMP-compliant ensures constant supply of clinical sample and commercial products. Our facility produces large molecules that are exported to all over the world.