Výroba rekombinantných klastrov (CLU). Slovensko

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  The Importance of Quality Control in Recombinant Clusterin Production

  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.

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  Scaling up Recombinant Clusterin Manufacturing for Commercial Use

  Our world class modern manufacturing facility has been established for large scale production of  Yaohai Biovýroba rekombinantného bravčového 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!

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  Meeting Global Demands for Recombinant Clusterin in Drug Developmen

  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.

Why choose Yaohai Recombinant Clusterin (CLU) Manufacturing?

• Systém kvality a súlad s globálnymi predpismi

  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.

• Profesionálna odbornosť a rozsiahle skúsenosti

  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.

• Robustný dodávateľský reťazec a výrobné kapacity

  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.

• Prispôsobenie, efektívnosť a nákladová efektívnosť

  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.

Súvisiace kategórie produktov

• Produkcia prekurzora inzulínu ako inklúzneho telieska
• Výroba rekombinantných klastrov (CLU).
• E. coli Inclusion Body Purification Process
• Proces prekladania inklúzneho tela
• Proces solubilizácie inklúzneho tela

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