At Yaohai, we aim to create a complex specific protein in biology -a pharmaceutical recombinant clusterin (CLU). And because this protein has potential to treatment for all you big, nasty diseases including Alzheimer's and prostate cancer as well as heart malady. By manufacturing superior CLU, we aspire to contribute productively to the advancement of therapies and solutions that serve people and enhance living conditions.
One is that good quality Biomanufacturing Recombinant Insulin Analog requires excellent materials only. Therefore, we need to ensure that everything which we are using is safe and 100% pure. Our team of professionals employ defined methods to extract and purify the CLU protein from such raw materials. Proceeding in this way ensures, that the final product is a high quality one, and as such ready for clinical applications.
We have been working on recombinant clusterin for many years, and over that time we found countless improvements. As we keep on doing we learn about the recent and best practises used by everybody; well at Yaohai a little bit difference. That way, we can ensure production of CLU is accessible to and convenient for our customers.
Well, we can do a lot -- for example, we've got the manual process of cloning down to a science -- but one simple on is that we have revolutionized cloning methods. Furthermore, we then use our knowledge of how the CLU protein actually works and apply it to computational tools. This we know, so that knowledge helps us build more efficient ways to create Rekombinantní inzulínová mutace Biomanufacturing. so seperating the cream from a whey.
In the current review, we apply modern tools and methods to analyze the properties of CLU protein. That is very beneficial in that it permits detecting flaws or contaminations that reduce planning much less secure and also much less effective beforehand. Its this process that helps us to maintain our high-quality standards and deliver a product that enables healthcare provider as well as the patients.
Our world class modern manufacturing facility has been established for large scale production of Yaohai Biomanufacturing rekombinantního prasečího inzulínu forest. To ensure that we make our production processes highly efficient and effective, these facilities are equipped with the most technologically-advanced aid available. We also spent years assembling a world-class team of experts who obsess over refactoring our manufacturing process to maximize the knowledge we can derive from this unruly, spiky little molecule. The team is learning the hard way how to try and provide some of what our customers need from us!
We all adopt a form of modular working helps us to understand what our customers want and then work with them in creating the perfect solution for their specific needs. We follow up with our customers to see if they are ok a while. We are also investigating on novel approaches to its recombinant production. And these efforts allow us to deliver best in class products.
Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have a quality system which is in line with current GMP standards and international regulations. Our regulatory team is knowledgeable in global regulatory frameworks to accelerate biological launches. We ensure traceable manufacturing processes and top-quality products that are compliant with the requirements of the US FDA, EU EMA, Australia TGA, and Recombinant Clusterin (CLU) Manufacturing. Yaohai BioPharma has successfully passed the audit on site of the European Union's qualified Person (QP) for our GMP quality system and production site. In addition, we've cleared the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.
Yaohai Bio-Pharma is a leading microbial biologics CDMO. Our main focus has been the production of Recombinant Clusterin (CLU) Manufacturing and therapeutics to treat pets, human and veterinary health. We have state-of-the-art RD platforms and manufacturing technology that cover the entire manufacturing process beginning with the development of microbial strains Cell banking, process and method development, through commercial and clinical manufacture that ensures the successful delivery of innovative solutions. Over time we've gained a vast knowledge of microbial-based bio processing. We have successfully completed more than 200 global projects, and help our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react promptly to market demands and provide tailored CDMO services due to our experience and expertise.
Yaohai Bio-Pharma, a Recombinant Clusterin (CLU) Manufacturing manufacturer of biological products, is a specialist in microbial fermentations. We have built a modern factory equipped with modern facilities and strong RD and manufacturing capabilities. Five drug substance production lines that are compliant with GMP standards for microbial purification and ferment, as well as two fill and finish lines for vials as well as cartridges, as well as needles that are pre-filled, are readily available. The available fermentation scales vary from 100L to 500L, 1000L, to 2000L. Filling volumes vary from 1ml to 25ml. Syringes or cartridges pre-filled are filled with the equivalent of 1-3ml. Our cGMP-compliant production facility ensures the availability of stable clinical samples and commercial products. The big molecules that are produced at our plant are readily available for international delivery.
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, Recombinant Clusterin (CLU) Manufacturing, 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.