Biológiai tisztítási folyamat fejlesztése Magyarország

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  Innovative approaches to biologics purification for better patient outcomes

  In a quest for the best biologics, Yaohai is always coming up with something new and different to cleanse and so rule out any living pleasantries in their cleansing process. Occasionally, the adoption of a new practice might yield better outcomes and be more beneficial to consumer health. The identification of new modalities to alleviate the suffering that accompanies disease. 

  
  

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  Building a robust biologics manufacturing process from purification to delivery

  Yaohai is also seeking a robust, end-to-end way to manufacture biologics This means that from the start, when they process living things to take out unwanted parts (clean and split), all the way through to the end, when their biologics are delivered into patients who need them, everything is done extremely carefully. They focus on delivering high level of attention to all details, ensuring that their biologics are safe and effective in treating sick people. 

  
  

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  Balancing efficiency and quality in biologics purification process development

  Yaohai must also rapidly, safely be biologics. This is because they aim to help many sick people, so it very important that their medicine is made as fast as possible. In the meantime, Yaohai be must make sure their biologics are excellent too so people can use them to recover and keep healthy.

  
  

Why choose Yaohai Biologics Purification Process Development?

• Testreszabás, hatékonyság és költséghatékonyság

  Yaohai Bio-Pharma is experienced in biologicals derived from microbial sources. We provide customized RD solutions and manufacturing, while minimising potential risks. We have worked on various modalities, including recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies enzymes, plasmid DNA various mRNAs, and more. We have specialized in multiple microorganisms, including Biologics Purification Process Development intracellular and extracellular secretion (yields up to 15g/L) and intracellular soluble bacteria and inclusion body (yields up to 10g/L). We have also established a BSL-2 fermentation platform to create bacteria-based vaccines. We are experts in improving processes, boosting product yields, and decreasing production costs. We have a highly efficient technology team that ensures timely and top-quality project delivery. This allows us to bring your unique products faster to market.

• Szakmai szakértelem és kiterjedt tapasztalat

  Yaohai Bio-Pharma is a leading Microbial biologics CDMO. We have been focused on microbial-produced therapeutics and vaccines for human, veterinary, and the management of pet health. We are equipped with Biologics Purification Process Development RD platforms as well as manufacturing technology that encompass the entire process beginning with the development of microbial strains cells, methods and processes, to commercial and clinical manufacturing which ensures successful implementation of cutting-edge solutions. We have acquired a large amount of experience in bio processing of microbial cells. We have delivered over 200 global projects, and help our clients with navigating the laws from the US FDA, EU EMA, Australia TGA, and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide tailored CDMO services.

• Robusztus ellátási lánc és gyártási képességek

  Yaohai Bio-Pharma, a Biologics Purification Process Development 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.

• Minőségi rendszer és globális szabályozási megfelelőség

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and Biologics Purification Process Development. We have developed a solid quality system that adheres to current GMP standards and regulatory requirements worldwide. Our regulatory team is knowledgeable on global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable with high-quality products as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma successfully passed an on-site audit conducted by a Qualified Person from the European Union (QP) to examine our GMP process and manufacturing facility. We also successfully been through the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

Kapcsolódó termékkategóriák

• Biológiai analitikai módszerfejlesztés
• Biológiai készítményfejlesztés
• Biológiai tisztítási folyamat fejlesztése

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